Non-invasive interventions for improving well-being and quality of life in patients with lung...

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Lung Cancer (2005) 50, 163—176 Non-invasive interventions for improving well-being and quality of life in patients with lung cancer—–A systematic review of the evidence Elinor Thompson a , Ivan Sol` a a,, Mireia Subirana a,b a Iberoamerican Cochrane Centre, Hospital de la Santa Creu i Sant Pau, Casa de Convalesc` encia, St. Antoni Maria Claret 171, 08041 Barcelona, Spain b Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Sant Antoni Maria Claret 171, 08041 Barcelona, Spain Received 4 April 2005; accepted 30 June 2005 KEYWORDS Systematic review; Lung neoplasms; Palliative care; Quality of life; Nursing process; Holistic health; Patient care Summary Despite advances in lung cancer treatment, the outlook for most patients remains grim. Many of them face a short survival time during which they may suffer physical and psychological problems related with the cancer and the treatment side-effects. There is a need for a high quality care to support patients and reduce symptoms as much as possible. This systematic review found that a spe- cialised nursing programme to reduce breathlessness was effective and that after patients’ treatment had finished, those cared by nurses did as well or even better than those cared by doctors. © 2005 Elsevier Ireland Ltd. All rights reserved. 1. Introduction Over one million people around the world die every year of lung cancer [1]. Although treatment advances have led to a steady increase in sur- vival, outlook for the majority with the disease remains grim with most patients having an average survival of about 8 months from diagnosis. During their last few months, patients may undergo inva- sive and toxic therapies while their general health gradually declines. People with lung cancer face a depressing and anxiety provoking future which can Corresponding author. Tel.: +34 93 291 95 27; fax: +34 93 291 95 25. E-mail address: [email protected] (I. Sol` a). have a devastating effect on their psychological and emotional health as well as that of their families and carers [2]. Non-invasive interventions may be helpful in attenuating symptoms, forming part of a holistic care package and facilitating an integra- tive approach to cancer care. This review assesses the effectiveness of non-invasive interventions in improving the well-being and the quality of life of patients with lung cancer. 2. Methods We searched Medline, CINAHL, CancerLit, Psyc- INFO, EMBASE, and the Cochrane Central Register of Controlled Trials to identify all published ran- 0169-5002/$ — see front matter © 2005 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.lungcan.2005.06.004

Transcript of Non-invasive interventions for improving well-being and quality of life in patients with lung...

Lung Cancer (2005) 50, 163—176

Non-invasive interventions for improvingwell-being and quality of life in patients with lungcancer—–A systematic review of the evidence

Elinor Thompsona, Ivan Sola a,∗, Mireia Subiranaa,b

a Iberoamerican Cochrane Centre, Hospital de la Santa Creu i Sant Pau, Casa de Convalescencia, St.Antoni Maria Claret 171, 08041 Barcelona, Spainb Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Sant Antoni MariaClaret 171, 08041 Barcelona, Spain

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eceived 4 April 2005; accepted 30 June 2005

KEYWORDSSystematic review;Lung neoplasms;Palliative care;Quality of life;Nursing process;Holistic health;Patient care

Summary Despite advances in lung cancer treatment, the outlook for mostpatients remains grim. Many of them face a short survival time during which theymay suffer physical and psychological problems related with the cancer and thetreatment side-effects. There is a need for a high quality care to support patientsand reduce symptoms as much as possible. This systematic review found that a spe-cialised nursing programme to reduce breathlessness was effective and that afterpatients’ treatment had finished, those cared by nurses did as well or even betterthan those cared by doctors.© 2005 Elsevier Ireland Ltd. All rights reserved.

. Introduction

ver one million people around the world dievery year of lung cancer [1]. Although treatmentdvances have led to a steady increase in sur-ival, outlook for the majority with the diseaseemains grim with most patients having an averageurvival of about 8 months from diagnosis. Duringheir last few months, patients may undergo inva-ive and toxic therapies while their general healthradually declines. People with lung cancer face aepressing and anxiety provoking future which can

∗ Corresponding author. Tel.: +34 93 291 95 27;ax: +34 93 291 95 25.

E-mail address: [email protected] (I. Sola).

have a devastating effect on their psychological andemotional health as well as that of their familiesand carers [2]. Non-invasive interventions may behelpful in attenuating symptoms, forming part ofa holistic care package and facilitating an integra-tive approach to cancer care. This review assessesthe effectiveness of non-invasive interventions inimproving the well-being and the quality of life ofpatients with lung cancer.

2. Methods

We searched Medline, CINAHL, CancerLit, Psyc-INFO, EMBASE, and the Cochrane Central Registerof Controlled Trials to identify all published ran-

169-5002/$ — see front matter © 2005 Elsevier Ireland Ltd. All rights reserved.oi:10.1016/j.lungcan.2005.06.004

164 E. Thompson et al.

Table 1 Included studies

1. Nursing interventions to manage breathlessness (two studies, 143 patients with lung cancer), (Corner, 1996a;Bredin, 1999a)

2. Nursing programmes (three studies, 416 patients with lung cancer), (McCorkle, 1989a; Sarna, 1998a; Moore, 2002a)3. Nutritional interventions (one study, 96 patients with lung cancer) (Evans, 1987)4. Psychotherapeutic interventions (1 study, 64 patients with lung cancer), (Linn, 1982)5. Exercise (one study, 104 patients with lung cancer) (Wall, 2000a).6. Reflexology (one study, 10 patients with lung cancer) (Stephenson, 2000)

a Studies which included exclusively lung cancer patients.

domised controlled trials and controlled clinical tri-als that assessed non-invasive interventions for thecare of lung cancer patients. Non-invasive inter-ventions were defined as: (i) physical treatmentnot requiring catheterisation, skin puncture, intu-bation, incision, drainage, endoscopy or pharma-cological intervention [3] and (ii) any treatment oraction performed to enhance well-being or qual-ity of life. Studies that included patients with lungcancer as well as cancers in other sites (e.g. breast,colon, etc.) were only included if separate data onpatients with lung cancer were reported.

Outcome measures were: (i) well-being definedas: a subjective or objective perception of improve-ment in physical health, or of symptoms related tocancer, to metastases, or to side-effects of treat-ment of the illness, and/or a subjective or objectiveperception of improvement of psychological func-tioning and (ii) quality of life defined as: an indi-vidual’s perception of position in life in the contextof the culture and value systems in which he or shelives and in relation to their goals, expectations,standards and concerns [4].

Two reviewers independently assessed all 814references retrieved by the searches to identify

if most of the criteria were either not met or notreported.

Descriptive and quantitative data was extractedindependently from included studies by two review-ers using a pre-designed form. Discrepancies wereresolved by discussion with a third reviewer wherenecessary.

2.1. Characteristics of included studies

Nine studies were included in this review. We clas-sified these studies into six groups according to theinterventions assessed (see Table 1). All trials useda randomised, controlled design unless otherwisestated.

2.1.1. Nursing intervention to managebreathlessnessTwo studies, one of which was a single centrepilot Corner [19] for the second, multi-centre trialBredin [20], evaluated a nursing intervention tomanage breathlessness in patients with lung can-cer and mesothelioma. The intervention, which wasindividually tailored to each patient, was basedofppisdisedItb1tafo

potentially relevant studies. A total of 66 full textarticles were reviewed of which 20 were potentiallyeligible for inclusion in the review. Of these, twowere excluded [5,6] because the outcome (placeof death) did not correspond to the review’s inclu-sion criteria. A further nine [7—15] were excludedbecause separate data on patients with lung cancerwere not reported.

We analysed the following individual componentsof study quality [16] rather than assigning a quanti-tative score as this has been criticised as being mis-leading rather than useful [17,18]: (i) randomisa-tion method, (ii) randomisation concealment, (iii)blinding, (iv) reporting of follow-up/losses, (v) sam-ple size calculation. We judged a study to be ofhigh quality if all of the criteria were met (with theexception of blinding if this were impossible giventhe intervention), of medium quality if there wasdoubt over one of the criteria and of low quality

n breathlessness rehabilitation techniques andocused on integrating the psychological and thehysical aspects of dyspnoea. Intervention groupatients attended a weekly nursing clinic for a min-mum of 3 and up to 8 weeks (6 weeks in the pilottudy). Patients in the control group received stan-ard care as well as having their breathlessness andts effects on their lives monitored. Outcome mea-ures in both studies were: (1) patient’s subjectivexperience of breathlessness, levels of anxiety andepression [21] and physical functioning [22—24].n-depth interviews with patients were also under-aken in the pilot study to explore experience ofreathlessness. Outcomes were measured at weeks, 4 and 12 (pilot study) and 1, 4 and 8 (multicen-re study). Improvements from baseline to weeks 4nd 12 were reported in the first study, and changerom baseline to week 8 was reported for the sec-nd study.

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2.1.2. General nursing programmesTwo trials assessed the effectiveness of nurse fol-low up programmes compared with standard physi-cian follow up for patients with lung cancer. Inthe earlier study, McCorkle [25] patients wererandomly allocated to one of three possible pro-grammes: (i) specialised home care programme(OHC) delivered by masters’ level nurses trainedto provide care to patients with advanced cancer,(ii) standard home care programme (SHC) deliv-ered by an interdisciplinary team of health pro-fessionals, (iii) office care programme (OC) pro-vided by the patient’s physician without involvingany specialised home nursing care. Primary out-comes were: (i) symptom distress, (ii) pain, (iii)patient concerns, (iv) mood, (v) functional status,(vi) health perceptions and (vii) health service util-isation all measured using standarised instruments[26—31].

The second study of nurse follow up [32] com-pared the effectiveness of nurse led follow up withconventional medical follow up in patients withlung cancer who had completed initial treatmentand were expected to survive at least 3 months.Patients randomised to the intervention group wereactcnprfrupdops

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2.1.3. Nutritional interventionsIn a study of the effects of a nutritional interven-tion [37], patients with either previously untreatedmetastatic NSCLC or colorectal cancer were ran-domised at the start of chemotherapy to one ofthree groups: (i) nutritional advice interventiondescribed as ‘‘standard’’ consisting mainly of oralnutrition supplemented if necessary by enteral orparenteral support to achieve a targeted caloricintake (TCI), (ii) nutritional intervention whichaimed to increase dietary protein intake so that25% of the total caloric intake was from proteinsources, with additional daily zinc and magnesiumsupplements—–‘‘augmented’’ nutrition and (iii) nospecific nutritional intervention or counselling—–adlib diet (control group). All patients with lung can-cer received vindesine and cisplatin chemotherapy.Outcomes of interest were: (1) tumour response tochemotherapy and survival duration according tothe level of nutritional intervention, (2) the effectsof the nutritional intervention on the tolerance tochemotherapy, and (3) the effect of pretreatmentnutritional intake, weight loss and serum albuminon survival duration.

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ssessed either by phone or in the clinic by specifi-ally trained nurse specialists using a protocol. Fur-her contacts were made as necessary and patientsould initiate contact themselves. The focus ofursing follow up was on information provision, sup-ort and service coordination, but the nurse wasesponsible for all care unless the patient neededurther treatment. Patients in the control groupeceived conventional medical (physician) followp. Primary outcomes were quality of life [33] andatient satisfaction measured using a specificallyesigned and validated questionnaire [34]. Sec-ndary outcomes were overall, symptom-free androgression-free survival, and general practitioneratisfaction.

One study [35] assessed the effects on symp-om distress of using a structured nursing assess-ent protocol in patients with advanced lung

ancer. All patients completed structured instru-ents for the assessment of symptoms. Ques-

ionnaires from patients allocated to the inter-ention group were summarised and shared withhe nursing staff to help enhance their assess-ent of the patient’s needs while questionnaires

rom control group patients were placed in sealednvelopes and these patients received standardursing needs assessments. The actual interven-ions which nurses then undertook were not a focusf the study. Outcomes measured were symptoms,motional distress and functional status [21,26,30,6].

.1.4. Psychotherapeutic interventionne study assessed the effects of counselling inatients with end stage cancer, with results forung cancer patients reported separately [38]. Allatients were seen by the same counsellor withxpertise in care in the end of life stage, severalimes a week from entry to the study until death.he therapist also offered support to the patient’selatives after the death. The main outcome mea-ure of interest was quality of life, defined byepression, self-esteem, life satisfaction, alien-tion and locus of control each assessed usingalidated measurement scales [29,39—42], othereasures included functional status [43] and sur-

ival from study entry and from diagnosis untileath.

.1.5. Exercisene study evaluated the effects of a pre-operativexercise programme [44] in improving the subjec-ive perception of hope and power, measured usingalidated instruments [45,46] in patients with earlytage lung cancer. The exercise programme con-isted of a number of structured arm, leg andreathing exercises as well as stair climbing andalking.

.1.6. Reflexologyhe only study in this category had a pre/postrossover study design and evaluated the effectf a short reflexology intervention in patients with

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breast and lung cancer [47]. Patients served as theirown controls.

3. Results

An overview of the design, quality and results ofeach study is shown in Table 2. Given the hetero-geneity of both interventions and outcomes mea-sured we did not undertake a quantitative poolingof the results. Critical review of the study designof each article found that four were of high qual-ity, two of medium quality and three of low qual-ity (Table 2). Four interventions were found to bemore effective than the control intervention. Anursing intervention improved breathlessness com-pared with no intervention [19,20], nursing followup programmes provided equal or better patientsatisfaction and symptom control compared withphysician follow up [32], a counselling interven-tion improved quality of life [38], and finally anexercise programme improved the power percep-tion on preoprerative patients [44]. There was noevidence that a nutritional intervention improvedwell-being. The studies of a nurse protocol [35] and

be questioned [48] and further research needs toaddress how potential barriers to successful imple-mentation of this kind of programme in clinicalpractice might be overcome.

Also effective were the two nurse led follow upprogrammes. McCorkle found a delay in increase insymptom distress, patient dependency and reducedhealth perceptions in the two groups who receivedthe nursing care programmes compared with thephysician office care group. These findings suggestthat providing care in the home may help to delaythe onset of deterioration and increased depen-dency by about 6 weeks compared with the stan-dard care group. Although, a relatively short time,this may nevertheless have a high value for thepatient at the end of their life. The later study [32]was of a high quality design and showed significantimprovements at 3 months not only in patient satis-faction, but also in degree of dyspnoea experiencedamong those in the intervention group comparedwith the control group. At 12 months, althoughnumbers left in the study were smaller and find-ings less reliable, there were significant improve-ments in emotional functioning in patients who hadreceived the nurse follow up programme comparedw

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of reflexology [47] were of insufficient quality todraw conclusions.

4. Discussion

In this review of studies of non-invasive interven-tions for the treatment and care of patients withlung cancer, we included nine studies covering sixtypes of intervention. Although several other stud-ies were identified by the searches in which pal-liative interventions were applied in patients withcancer, including those with lung cancer, only stud-ies in which data on lung cancer patients could beseparately identified were included.

Three interventions were found to be moreeffective than control. Nursing intervention toimprove breathlessness. The high quality, multicen-tre study by Bredin et al. (preceded by a pilot study[19]) found that a multi-faceted, individually tai-lored intervention to help reduce breathlessnesswas more effective than no intervention. Althoughthese findings are encouraging, the multi-centrestudy required the recruitment of nurses from sixdifferent centres around the UK, and considerableeffort was undertaken to ensure that the interven-tion was delivered in a uniform way. The feasibilityof undertaking such training and the practicalitiesof delivering such an intervention under similar con-ditions in normal day to day clinical practice may

ith controls.Although the services provided in these two stud-

es were different in many aspects, not least inhe provision at home versus hospital, there wereevertheless some common features which mayave acted on a similar mechanism to produceome relatively non-specific but tangible improve-ents in the patient’s illness experience. It is

nown that patients with cancer have consider-ble need for emotional and psychological support49] and it seems credible that physicians work-ng in busy hospital outpatient clinics or even pri-ate offices may not be able to provide same levelf empathy as that provided by nurses in theserogrammes.

These two studies were conducted in differ-nt countries, over 10 years apart. Although theirndings may give some general pointers as to theffectiveness of nurse follow up programmes in theommunity for patients with lung cancer, furtheresearch in different settings is needed to con-rm the findings. Harmonising research such thathe same outcomes are evaluated in different stud-es with the same measurement instruments wouldnable more robust conclusions to be drawn moreuickly. In both studies the nurses who were givinghe care underwent specific training programmes.urther information is needed on what would con-titute appropriate training to enable a nurse toive an optimal level of psychological and emo-ional support while being sufficiently alert to the

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Table 2 Characteristics of included studies

Study Participants (IG,interventiongroup; CG,control group)

Study quality Results (IG, intervention group; CG, control group) Comments

Ref: Corner Diagnosis: lungcancer

Randomisation:not described

IG CG p Scores aremedianimprovementfrom baseline

Intervention: Non-pharmacologicalintervention forbreathlessness inlung cancer

N: 20 (IG = 11) Allocationconcealment: notdescribed

Breathlessness at best Positive scoresindicateimprovement

Setting: singlecentre, UK

M/F: 12/8 Blinding: no 4 weeks 0.7 −1.5 P = comparison ofchange scoresbetween the twogroups using theMann—Whitneytest

Median age:55(IG); 69(CG)

Follow-up fullyreported: yes

12 weeks 0.5 −0.5 <0.02

Sample sizecalculation: no

Breathlessness at worst

Overall qualityassessment: low

4 weeks 0.3 0

12 weeks 3.5 0 <0.05Distress due to breathlessness4 weeks 3.0 0.512 weeks 5.3 −1.0 <0.01

Ref: Bredin Diagnosis: lungcancer andmesothelioma

Randomisation:adequate

IG CG p Scores aremedian changefrom baseline

Intervention: non-pharmacologicalintervention forbreathlessness inlung cancer

N: 103 availablefor analysis(IG = 51)

Allocationconcealment: yes

Breathlessness at best Negative scoresindicateimprovement

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Table 2 (Continued )

Study Participants (IG,interventiongroup; CG,control group)

Study quality Results (IG, intervention group; CG, control group) Comments

Setting: six centres,UK

M/F: 76/27 Blinding: no 8 weeks 1.3 7.0 0.03 Only itemsshowingstatisticallysignificantdifferencebetween groupsare shown fornon-breathlessnessoutcomes

mean age:68(IG); 67(CG)

Follow-upreported: yes

Breathlessness at worst

Sample sizecalculation: yes

8 weeks 1.0 4.8 0.14

Overall qualityassessment: high

Distress due to breathlessness

8 weeks 0 10 0.09WHO performance status8 weeks 0 2 0.02Depression (HAD scale)8 weeks 0.5 6 0.02Physical symptoms (Rotterdamscale—–subitems: R41, R43, R44)8 weeks 0 5.5 0.05

Ref: McCorkle Diagnosis: lungcancer

Randomisation:adequate

IG1 IG2 CG p Occasions (Occ)approximately 6weeks apart

Intervention: homenursing care forlung cancerpatients

N: 166 Allocationconcealment:adequate

Enforced social dependency Similar trendseen also forsymptom distress

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Setting:multicentre,Washington state,USA

Home care(IG)1 = 45

Blinding: no Occ1 22.33 21.68 21.74

Home care(IG)2 = 42

Follow-upreported:incomplete

Occ2 22.67 20.97 24.85 0.02

Office care(CG) = 46

Sample sizecalculation: yes

Occ3 24.57 24.90 25.17

M/F: 105/61 Overall qualityassessment:medium

Mean age: 66(range 18—89)

Ref: Moore Diagnosis: Lungcancer andmesothelioma

Randomisation:adequate

3 Months IG CG p Scores onEORTC’s qualityof life corequestionnaireshowingsignificantdifferencesbetween groups.Values aremedians

Intervention: nurseled follow upversusconventionalphysicianfollow-up

N: 202 (IG = 99) Allocationconcealment: yes

Dyspnoea 25.0 33.3 0.03 Score onvalidated patientsatisfactionquestionnaire.Values aremedians

Setting:multicentre, UK

M/F: 140/63 Blinding: no 12 Months

Mean age: 67(range 49—89)

Follow-upreported: yes

Emotional functioning 91.7 66.7 0.03

Sample sizecalculation: yes

Patient satisfaction

Overall qualityassessment: high

Organisation of care 81.3 71.9 <0.001

Information and advice 77.1 68.8 <0.001Satisfaction with care 78.4 70.0 0.005

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Table 2 (Continued )

Study Participants (IG,interventiongroup; CG,control group)

Study quality Results (IG, intervention group; CG, control group) Comments

Ref: Sarna Diagnosis: lungcancer (stage IIIor IV)

Randomisation:not reported

Multivariate summary showed meansymptom distress scores higher in controlgroup subjects compared with interventiongroup

Intervention:structured nursingassessment ofsymptom distress

N: 48 Allocationconcealment: notreported

Setting:multicentre, USA

M/F: 24/24 Blinding: no

Mean age: 62(39—79)

Follow-upreported: nolossesSample sizecalculation: noOverall qualityassessment: low

Ref: Evans Diagnosis: NSCLC(patients withcolorectal canceralso included instudy but onlyNSCLC reportedhere)

Randomisation:adequate

No significant difference in tumour responsebetween groups or in survival (SG = 27.5%;AG = 20%; CG = 14.7%).

Although 60% ofpatients in bothcontrol groupsrequired enteralnutrition byprotocol only 10%in the SG, and 7%in the AGreceived it. Themain reason forwhich waspatient refusal

Intervention: oralnutritionalsupport duringchemotherapy

N: 96 Allocationconcealment: yes

Caloric intake increased significantly in bothintervention groups compared with controlgroup (SG and AG = 91% vs. CG = 62%;p < 0.0001). Less weight loss in interventiongroup was observed, but difference was notsignificant (SG and AG = −1.2% vs.CG = −3.1%; p = 0.6).

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Setting: threecentres USA andCanada

M/F: 64/32 Blinding: no Median survival times were similar in allgroups (SG = 8 months; AG = 7 months; CG = 6months), with no significant differencesbetween groups. There were no significantdifferences between any of groups in eitherthe percentage of target dose ofchemotherapy achieved, or in the degreesof toxicity experienced.

Median age:IG1 = 57, IG2 = 59,CG = 61

Follow-up fullyreported: yes

Sample sizecalculation: noOverall qualityassessment: high

Ref: Linn Diagnosis:end-stage (stageIV) lung cancer(the study alsoincluded patientswith other typesof cancer, butonly data aboutlung cancerpatients isreported here)

Randomisation:adequate

Quality of life Higher mean QOLscores indicatesless favourableresponse

Intervention:counselling forquality of life,functional statusand survival

N: 64 (IG = 33) Allocationconcealment: notreported

At 3 months:

Setting: singlecentre, USA

M/F: 64/0 Blinding:assessors blinded

Significant differences in favour ofintervention group (p < 0.05) in mean scoresfor the following 4/5 QOL variables (IG vs.CG):

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Table 2 (Continued )

Study Participants (IG,interventiongroup; CG,control group)

Study quality Results (IG, intervention group; CG, control group) Comments

Median age: 58(range 45—77)

Follow-up fullyreported: data onone patient werelost

Depression: 10.8 vs. 14.2; F = 7.69

Sample sizecalculation: no

Alienation: 3.2 vs. 4.9; F = 4.68

Overall qualityassessment:medium

Life satisfaction: 36 vs. 48.1; F = 9.07

Self esteem: 43.4 vs. 56.3; F = 8.23At 12 months:Significant differences in favour ofintervention group (<0.05) for all QOLvariablesF-ratio for multivariate difference=18.78(p < 0.01)Functional status and degree of impairment:no significant differencesSurvival: no significant differences

Ref: Wall Diagnosis: lungcancer (stage IA,IB, IIA, IIB, or IIIANSC carcinoma)

Randomisation:adequate

Hope: no significant differences betweenthe groups at any time of the study

Higher meanpower scoresindicates morefavourableresponse

Intervention:preoperativeexerciseprogramme forwell-being(measuredthrough thepatients’perceptions ofhope andperceivedself-power)

N: 104 (IG=53) Allocationconcealment:adequate

Power: differences were observed betweengroups over time, showing a beneficialeffect of participation in the exerciseprogramme (F(2) = 12.09; p < 0.001)

Baseline: 7—10days beforesurgery at thetime of diagnosis

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Setting: singlecenter, USA

M/F: 53.8%/46.2% Blinding: no Power at baseline: IG: 274.1(37) vs. CG:277.5(36.1)

T2: day beforesurgery,coinciding withthe end of theexercise program

Median age: 65(37—83)

Follow-up fullyreported: yes

Power at T2: IG: 284.7(39.3) vs. CG:267.2(43.9)

T3: 4—6 aftersurgery

Sample sizecalculation: yes

Significant increase in the IG (t(51) = −2.68,p = .01)

No statisticallysignificantdifferencesbetween groupswere found forthe relation ofhope and power

Overall qualityassessment: high

Significant decrease in the CG (t(50) = 2.72,p = .01)Power at T3: IG: 292.3(39.3) vs. CG:266.3(45.5)Significant increase in the IG between BLand T3 (t(48) = −3.73, p = .001), but notbetween T2 and T3.Sustained decrease in the CG (t(47) = −0.29,p = 0.78)

Ref: Stephenson Diagnosis: lungcancer (fivepatients withmetastases)

Randomisation:adequate

Mean pre-intervention anxiety scores werehigher than those of the pre-control time(53.60 (S.D. = 30.6) vs. 39.60 (S.D. = 29.96)).Mean post-intervention scores lower thanpost-control time scores (20 (S.D. = 22.36)vs. 33.60 (S.D. = 24.94)).

Anxiety wasmeasured with anvisual analoguescale (reliableaccording to theauthors)

Intervention: footreflexology foranxiety

N: 10 (fivepatients receivedthe interventionfirst)

Allocationconcealment:inadequate

post-/pre-score difference = −33.6;p = 0.002.

Setting: singlemedical-oncologyunit, USA

M/F: 8/2 Blinding: no Post-/initial score difference = −6; p = 0.99.

Mean age: 68.7(2.69)

Follow-up fullyreported: nolosses

Difference between groups = −27.6; p = 0.02.

Sample sizecalculation: no

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need for referral for medical care should the needarise.

The third trial to show beneficial results evalu-ated the effectiveness of counselling in late stagelung cancer patients and found short term, posi-tive effects of the intervention on depression lev-els, life satisfaction and self esteem. This trialwas of medium quality and it was noteworthy thatall the counselling sessions were given by a singlepsychotherapist. These findings would need to bereproduced in a larger study, involving several ther-apists to verify their reproducibility.

Findings from Bredin, Corner, Moore, McCorkleand Linn support the notion that a supportive inter-vention may have benefits not only on emotionaland psychological states (anxiety, depression) butalso on physical symptoms such as dyspnoea. Impor-tant aims of such an intervention appear to be toincrease the patient’s understanding of their illnessand its meaning for them, to increase their abilityto be active participants in their own therapy andto give them an opportunity to express and exploretheir feelings and concerns about their symptoms,diagnosis and future. Whatever its exact format, anintervention that enables the patient to develop a

cal location of that tumour (lung, breast, prostate,etc.) but also by the social, psychological and emo-tional meanings that arise from that cancer site[51].

For the sake of practicality we categorised stud-ies by the type of intervention delivered, but mightequally have categorised studies on the basis of thestage of the illness [51]. Interventions were differ-ent in their purpose depending on the progressionof the patient’s illness. At the early phase of diag-nosis, interventions tested were more educationoriented, providing patients with coping skills andguiding the management of disease-related issues.In more advanced disease stages, the interventionscentred more on individual needs complemented byemotional support, while interventions tested forpatients with terminal illness focused on improvingpatient quality of life and developing strategies tomanage existential issues and topics related withmourning among relatives and carers. This alter-native classification raises the question as to whatkind of non-invasive interventions are best suitedat different stages of the disease for a patient withcancer?

Finally there is a need for further research intoptttaTpcfdirdtreiarp

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supportive and empathetic relationship with a suit-ably trained health professional appears to be key[50].

The best way to deliver this kind of service (eco-nomically and practically) and who are the mostappropriate professionals to provide it is not clearfrom the studies included in this review. Nursesare not counsellors but have multi-faceted skills,whereas counsellors may have the psychotherapeu-tic skills but have less knowledge of the disease pro-cess. This supports the need for multi-disciplinaryteams to cater for the individual needs of patientsbut also interdigitating with conventional medicalservices providing treatment and support. Such aservice is likely to be resource intensive not onlyin terms of need for professional time but also pro-fessional training and ongoing support and practicalarrangements.

We have concentrated for this review, whichformed part of a larger study assessing the feasibil-ity of bringing together quantitative and qualitativeresearch evidence, on lung cancer patients only.Many of the interventions would benefit patientswith other cancers, indeed we excluded severalstudies from this review because the interventionwas delivered to patients with different cancersand it was not possible to separate the data onlung cancer. More qualitative research is needed toexplore whether and what different illness experi-ences may be depending on the site of the primarycancer—–influenced not only by the actual physi-

alliative care interventions. Such research needso try and illuminate the underlying mechanismshat link psychological and emotional mechanismso physical symptoms (the why question) as wells assessing effectiveness (the what question).he difficulties in conducting randomised trials inalliative care are well recognised [52]. We haveoncentrated only on randomised controlled trialsor the purpose of this review but other valuableata from qualitative studies can also add to thensights gained from these [53—57], we report aeview of this evidence elsewhere [58]. Where ran-omised controlled trials are conducted these needo be coordinated so that maximum use of scarceesources can be obtained. Such research shouldxplore the effectiveness and feasibility of provid-ng this kind of care within the ‘real life’ settings opposed to the sometimes artificial setting of aesearch study, and should fully take into accountatients’ and carers’ specific needs and wishes.

ther published version of this review

his paper is based on a Cochrane review publishedn The Cochrane Library [59]. Sola I, Thompson, Subirana M, Lopez C, Pascual A. Non-invasiventerventions for improving well-being and qualityf life in patients with lung cancer. The Cochraneatabase of Systematic Reviews 2004, Issue 4, Art.o.: CD004282 (Copyright Cochrane Library, repro-

Non-invasive interventions for improving well-being and quality of life 175

duced with permission). Cochrane reviews are reg-ularly updated as new evidence emerges and inresponse to comments and criticisms.

Acknowledgements

This study was supported by a grant from Institutode Salud Carlos III, AETS 02/10050. The authors aremembers of the ‘‘Red Tematica de Medicina Basadaen la Evidencia’’ (FIS G03/090).

References

[1] International Agency for Research on Cancer. Cancer inci-dence, mortality and prevalence worldwide. GLOBOCAN2000. 2000.

[2] Sarna L. Effectiveness of structured nursing assessmentof symptom distress in advanced lung cancer. Oncol NursForum 1998;25:1041—8.

[3] Official Journal of the European Communities L. Directive2001/83/EC on the community code relating to medicinalproducts for human use. November 28, 2001;311:p. 67.

[4] World Health Organization. Study protocol for the WorldHealth Organization project a develop a Quality of Life

[

[

[

[

[

[15] Greer S, Moorey S, Baruch JD, Watson M, RobertsonBM, Mason A, et al. Adjuvant psychological therapy forpatients with cancer: a prospective randomised trial. BMJ1992;304:675—80.

[16] Juni P, Altman DG, Egger M. Assessing the quality of con-trolled clinical trials. BMJ 2001;323:42—6.

[17] Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ,Gavaghan DJ, et al. Assessing the quality of reports of ran-domized clinical trials: is blinding necessary? Control ClinTrials 1996;17:1—12.

[18] Downs SH, Black N. The feasibility of creating a checklist forthe assessment of the methodological quality both of ran-domised and non-randomised studies of health care inter-ventions. J Epidemiol Community Health 1998;56:377—84.

[19] Corner J, Plant H, A’Hern R, Bailey C. Non-pharmacologicalintervention for breathlessness in lung cancer. Pall Med1996;10:299—305.

[20] Bredin M, Corner J, Krishnasamy M, Plant H, Bailey C, A’HernR. Multicentre randomised controlled trial of nursing inter-vention for breathlessness in patients with lung cancer. BMJ1999;318:901—4.

[21] Zigmond AS, Snaith RP. The hospital anxiety and depressionscale. Acta Psychiatr Scand 1983;67:361—70.

[22] Kinsman RA, Yaroush RA, Fernandez E, Diks JE, Schocket M,Fukupera J. Symptoms and experiences in chronic bronchi-tis and emphysema. Chest 1983;83:755—61.

[23] World Health Organisation. WHO handbook for reportingresults of cancer treatment. Geneve: World Health Organ-isation, 1979.

[

[

[

[

[

[

[

[

[

[

[

assessment instrument (WHOQOL). Quality of Life ResearchGroup, 1993.

[5] Grande GE, Todd CJ, Barclay SI, Farquhar MC. Does hospi-tal at home for palliative care facilitate death at home?Randomised controlled trial. BMJ 1999;319:1472—5.

[6] Grande GE, Todd CJ, Barclay SI, Farquhar MC. A random-ized controlled trial of a hospital at home service for theterminally ill. Palliat Med 2000;14:375—85.

[7] Forester B, Kornfeld DS, Fleiss JL, Thompson S. Psychother-apy during radiotherapy: effects on emotional and physicaldistress. Am J Psychiatr 1985;142:22—7.

[8] Forester B, Kornfeld DS, Fleiss JL. Group psychotherapyduring radiotherapy: effects on emotional and physical dis-tress. Am J Psychiatr 1993;150:1700—6.

[9] Ovesen L, Allingstrup L, Hannibal J, Mortensen EL, HansenOP. Effect of dietary counseling on food intake, bodyweight, response rate, survival, and quality of life in cancerpatients undergoing chemotherapy: a prospective, random-ized study. J Clin Oncol 1993;11:2043—9.

10] Wilkie DJ, Kampbell J, Cutshall S, Halabisky H, Harmon H,Johnson LP, et al. Effects of massage on pain intensity, anal-gesics and quality of life in patients with cancer pain: a pilotstudy of a randomized clinical trial conducted within hos-pice care delivery. Hosp J 2000;15:31—53.

11] Jacobsen PB, Meade CD, Stein KD, Chirikos TN, SmallBJ, Ruckdeschel JC. Efficacy and costs of two forms ofstress management training for cancer patients undergoingchemotherapy. J Clin Oncol 2002;20:2851—62.

12] Li Z, Zhang H, Zhang H. Psychological intervention on men-tal health of perioperative patients with cancer. Chin Men-tal Health J 2002;16:147—8.

13] Rawl S, Given B, Given C, Champion V, Kozachik S, BartonD, et al. Intervention to improve psychological functioningfor newly diagnosed patients with lung cancer. Oncol NursForum 2002;29(6):967—75.

14] Weinrich SP, Weinrich MC. The effect of massage on pain incancer patients. Appl Nurs Res 1990;3(4):140—5.

24] DeHaes J, Olschewsky M, Fayers P, Visser MRM, Cull A,Hopwood P. The Rotterdam Symptom Checklist: A Manual.Groningen: Northern Centre for Healthcare Research, Uni-versity of Groningen; 1996.

25] McCorkle R, Benoliel J, Donaldson G, Georgiadou F, Moin-pour C, Goodell B. A randomized clinical trial of home nurs-ing care for lung cancer patients. Cancer 1989;64:1375—82.

26] McCorkle R, Young K. Development of symptom distressscale. Cancer Nurs 1978;1:373—8.

27] Weisman AD, Worden J. Project Omega: Coping and Vulner-ability in Cancer Patients. Boston: Harvard Medical School;1977.

28] McNair D, Lorr M, Dropplemen L. Edits Manual: Profile ofMood States. San Diego: Educational and industrial testingservices; 1971.

29] Benoliel JQ, McCorkle R, Young K. The development of asocial dependency scale. Res Nurs Health 1980;3:3—10.

30] Stewart AL, Kamberg CJ. Physical functioning measures.In: Stewart AL, Ware JE, editors. Measuring Functioningand Well-Being: The Medical Outcomes Study Approach.Durham, NC: Duke University Press; 1992. p. 86—101.

31] Melzack R. The short form McGill pain questionnaire: majorproperties and scoring methods. Pain 1987;30:191—7.

32] Moore S, Corner J, Haviland J, Wells M, Salmon E, NormandC, et al. Nurse led follow up and conventional medical fol-low up of patients with lung cancer: randomised trial. BMJ2002;325:1145—51.

33] Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A,Duez NJ, et al. The European Organization for Research andTreatment of Cancer QLQ-C30: a quality-of-life instrumentfor use in international clinical trials in oncology. J NatlCancer Inst 1993;85:365—76.

34] Thomas LH, McColl E, Priest J, Bond S, Boys R. TheNewcastle satisfaction with nurses scale: an instrumentfor quality assessment of nursing care. Qual Health Care1996;5:67—74.

176 E. Thompson et al.

[35] Sarna L. Effectiveness of structured nursing assessmentof symptom distress in advanced lung cancer. Oncol NursForum 1998;25:1041—8.

[36] Karnofsky DA, Burchenal J. Clinical evaluation of chimio-therapeutic agents in cancer. In: MacLeod CM (ed.), Evalu-ation of Chemotherapeutic Agents. NY: Columbia Press, pp.191—205.

[37] Evans WK, Nixon DW, Daly JM, Ellenberg SS, Gardner L,Wolfe E, et al. A randomized study of oral nutritional sup-port versus al lib nutritional intake during chemotherapyfor advanced colorectal and non-small-cell lung cancer. JClin Oncol 1987;5:113—24.

[38] Linn M, Linn B, Harris R. Effects of counseling for late stagecancer patients. Cancer 1982;16:1048—55.

[39] Sherwood JJ. Self-identity and referents others. Sociometry1965;28:66—81.

[40] Cantril H. The Pattern Of Human Concerns. New Brunswick,NJ: Rutgers University Press; 1965.

[41] Srole L. Social integration and certain corollaires: anexploratory study. Am Sociol Rev 1956;21:709—16.

[42] Rotter JB. Generalised expectancies for internal versusexternal control of reinforcement. Psychol Monogr 1966:80.

[43] Linn MW. A rapid disability rating scale. J Am Ger Soc1967;15:211—4.

[44] Wall L. Changes in hope and power in lung cancer patientswho exercise. Nurs Sci Quat 2000;13:234—42.

[45] Herth K. Abbreviated instrument to measure hope:development and psychometric evaluation. J Adv Nurs1992;17:1251—9.

[46] Barrett, EAM. Development of an instrument to measure

ness intervention into clinical practice. Eur J Oncol Nurs2003;7:33—8.

[49] National Cancer Alliance. Patient-Centred Services: WhatPatients Say? Oxford: NCA; 1996.

[50] Thompson E, Subirana M, Sola I, Lopez C, Pascual A. Effec-tiveness of non-invasive and non-pharmacological interven-tions to improve well-being of lung cancer patients: system-atic review. Unpublished final report, AETS 02/10050, 2002.

[51] Fawzy FI. Psychosocial interventions for patients withcancer: what works and what doesn’t. Eur J Cancer1999;35:1559—64.

[52] Higginson I. Evidence based palliative care. BMJ1999;319:462—3.

[53] O’Driscoll M, Corner J, Bailey C. The experience of breath-lessness in lung cancer. Eur J Cancer Care 1999;8:37—43.

[54] The A-M, Hak T, Koeter G, van der Wal G. Collusion indoctor-patient communication about imminent death: anethnographic study. BMJ 2000;321:1376—81.

[55] The A-M, Hak TK, Gerrit van der Wal. Radiographic imagesand the emergence of optimism about recovery in patientswith small cell lung cancer: an ethnographic study. LungCancer 2003;41:113—20.

[56] Murray SA, Boyd K, Kendall M, Worth S, Benton TF,Clausen H. Dying of lung cancer or cardiac failure. BMJ2002;325:929—34.

[57] Murray SA, Grant E, Grant A, Kendall. Dying from cancerin developed and developing countries: lessons from twoqualitative interview studies of patients and their carers.BMJ 2003;326:368—73.

[58] Thompson E, Sola I, Subirana M. A review of qualitative

[

power as knowing participation in change. Unpublishedmanuscript, 1987.

[47] Stephenson N, Weinrich S, Tavakoli A. The effects of footreflexology on anxiety and pain in patients with breast anglung cancer. Oncol Nurs Forum 2000;27:67—72.

[48] Johnson M, Moore S. Research into practice: the real-ity of implementing a non-pharmacological breathless-

research into the experience of lung cancer to comple-ment a systematic review of palliative care interventions,in press.

59] Sola I, Thompson E, Subirana M, Lopez C, Pascual A. Non-invasive interventions for improving well-being and qualityof life in patients with lung cancer. The Cochrane Databaseof Systematic Reviews 2004, Issue 4, Art. No.: CD004282.