Grds international conference on social science (4)

EFFECTIVENESS OF CHEMOTHERAPY

COUNSELING AMONG ONCOLOGY PATIENTS ON NAUSEA AND VOMITING BY

PHARMACISTS IN A GOVERNMENT HOSPITAL IN MALAYSIA-

A RANDOMISED CONTROLLED TRIAL

Name : Ummavathy PeriasamyProgram :PHD in Community HealthCo- Authors :Professor Dr.Sherina Mohd Sidik

:Professor Dr. Lekhraj Rampal :Dr. Siti Irma Fadhilah

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TABLE OF CONTENT• Introduction • Significance of Study • Study Justification• Objectives • Hypothesis • Literature Review • Materials and Methods • Results • Discussion • Conclusion • References

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INTRODUCTION• Cancer is a global public health concern.

According to the World Health Organization (WHO, 2007), by 2020 cancer related deaths will total above 11 million people worldwide, including 4.7 million people from developed countries and 5.5 million people from developing countries (NCI, 2004).

• Cancer refers to the uncontrolled growth and spread of cells. These cancer cells can reach almost all parts of the body, and growths usually invade surrounding tissues and may metastasize to distant sites (National Cancer Institute, 2004)

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• Cancer treatment can be done in four basic ways; through local treatments of surgery and radiotherapy, or through systemic treatments by using biological agents (for example hormones, antibodies and growth factors) and chemotherapy (NCI, 2008; NCI 2007).

• Chemotherapy, used alone or in combination with surgery and or radiotherapy, plays a major role in the treatment of cancer (NCI, 2008; NCI 2007).

• Counselling is designed to help cancer patients respond to challenges, the associated emotions and provide a safe environment for them to talk about their concerns (Forster, et al., 2003)

• In Malaysia, cancer is now the fourth leading cause of death among medically certified deaths and the estimated annual incidence of cancer is 30,000. National Cancer Registry estimate that 1 in 4 Malaysians may have cancer in their lifetimes (Lim, 2006).

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SIGNIFICANCE OF STUDY

• If this study is found to be effective, the present study would benefit the patients and the pharmacists.

• The pharmacist would be able to use the module as a guide during each counselling session with the oncology patients for every cycle during the chemotherapy regime.

• The module will enable pharmacists to spend more quality time with each patient receiving chemotherapy.

• Cancer patients would benefit by overcoming/reducing side effects (nausea and vomiting) induced by chemotherapy treatment and improve their quality of life.

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STUDY JUSTIFICATION

If the module is found to be effective in this study it can be implemented in other hospitals.

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OBJECTIVES

GENERAL OBJECTIVE:

•To develop, implement and evaluate the chemotherapy counselling module by pharmacists among oncology patients.

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SPECIFIC OBJECTIVES:

1.To develop and implement a module on chemotherapy counselling for cancer patients by pharmacists in government hospitals in Malaysia.

2.To evaluate the effectiveness of the chemotherapy counselling module in reducing chemotherapy induced physical effects (nausea and vomiting).

3.To evaluate the effectiveness of repetitive chemotherapy counseling in reducing chemotherapy induced physical effects (nausea and vomiting) among oncology patients receiving chemotherapy.

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HYPOTHESIS

• H1: The chemotherapy module is effective in reducing chemotherapy induced physical effects (nausea and vomiting).

• H2: Repetitive chemotherapy counselling is more effective than single counselling in reducing chemotherapy induced physical effects (nausea and vomiting).

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LITREATURE REVIEW• Cancer is the uncontrolled growth of abnormal cells in

the body (Moscow, et al., 2007).• It requires continuous treatment and monitoring over

the long term. To avoid drug related problems, cancer patients need advice on the appropriate self-care. This will ensure the maximum benefit from treatment (Possidente, et al., 2005).

• Patients require counselling to promote adherence, to educate patients on the adequate dosage, frequency of medication, what to do if dose is missed, timing of food and medication and any actions that should be taken in case of side effects (Brennan, 2004).

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LITREATURE REVIEW

• Chemotherapy is commonly used to treat cancer patients and reduce tumour relapse. However, chemotherapy induced side effects has been a major concern (Chabner, et al., 2005)

• Physical Effects (Prevelence) Nausea 90.9% (Piko, 2009 ) Vomiting 72.0% (Piko, 2009 )

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METHODOLOGY Study Location• The study was conducted at the day care unit and medical

wards Hospital Tuanku Jaafar, Seremban, Negeri Sembilan, Malaysia.

Study Design• A randomized placebo controlled study design was used in

this study. Study Population• Cancer patients (stage 1-4) aged 18 years old and above in

their first cycle and second cycle of chemotherapy treatment at Hospital Tuanku Ja’afar Seremban.

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SAMPLE SIZE CALCULATION

n2 = kn1

n1 = total number of sample in one group Zα = data for alpha; p =0.05, therefore 95% confidence interval desired (2 tailed test) =

1.96 Z β = data for beta; 10% beta error, therefore 90% power desired (one tailed test)=

1.28p1 = the proportion of disease free survival with chemotherapy at 5 years = 69% =

0.69 (NCI, 2012) p2 = The estimated proportion of disease free survival with chemotherapy at 5 years after intervention with the module on ‘Managing Patients on Chemotherapy’ by

Pharmacists (estimated proportion of overall survival with chemotherapy at 5 years with intervention:20% difference of the two groups) = 89% = 0.89

(Rosner, 2006)

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Zα = Z1 –α/2 = 1.96 Zβ = Z1 – β = 1.28 k = 1 (because n1 = n2 )

p1 = 0.69 p = (p1 + p2) / 2 = 0.79q1 = 1- 0.69 = 0.31 q = 1 – 0.79 =0.21p2 = 0.69 + 0.2 = 0.89 ∆ = p1 – p2 = 0.69 – 0.89 = - 0.2q2 = 1- 0.89 = 0.11

= 80.55 ~ 81 per group = 81 x 2 =162

The minimum number of participants required in this study was 81 for each group. Therefore, a total sample size of 162 for both intervention and control groups was fixed with equal numbers in each group.

(Rosner, 2006)

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Figure 1: MODULE DEVELOPMENT

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A Focus group Discussion (FGD) was conducted among 20 oncology patients at HTJS

Based on the information gathered from the FGD a preliminary chemotherapy counselling module was developed. Some material was combined from the ‘Chemotherapy and You’

module developed by the National Cancer Institute.

A pilot test was conducted, among 40 oncology patients at HTAN. A baseline evaluation was done on physical effects, psychological effects, self-esteem and quality of life. 20 patients were recruited

into the intervention group and another 20 were recruited into the control group.

Patients from the intervention group of the pilot test were followed up for the next

cycle and given counselling based on the preliminary module. The control group continued receiving the current practice.

A second and third follow up was done consecutively and the outcome of the repetitive chemotherapy counselling was evaluated.

This was followed by an evaluation among pharmacist at HTJS to determine the need and

also the information needed in the module guide. All feedback were noted.

All information collected were incorporated into the chemotherapy counselling module in consultation with a panel of experts. The final version of the ‘Managing Patients on Chemotherapy’ by pharmacist

module was checked and rechecked to establish content validity

•INCLUSION CRITERIA Patients aged 18 years old and above with any type of cancer and stage undergoing chemotherapy treatment at HTJS for their first and second chemotherapy cycle. The ability of the patients to communicate well during the study and those who were Malaysian citizens.

•EXCLUSION CRITERIA Patients with severe communication problems such as speech or hearing difficultiesAny suicidal, tendencies, or psychotic features.

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Figure 2. STUDY POPULATION

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• List of patients registered for chemotherapy was obtained. Explanation of the study being conducted was given to the patients• The consent was obtained• Patient who met the inclusion and exclusion criteria were recruited into the study.

Randomization and Blinding

INTERVENTION GROUP

-Baseline evaluation was done using a set of validated and pretested questionnaires (similar to the control group)-1st counselling; was conducted after the baseline evaluation, where patients were counselled using the module on ‘Managing Patients on Chemotherapy’

-Patients were followed up according to their appointment dates for their next chemotherapy cycles-The same questionnaires were distributed again. This was followed by the 2nd counselling session.

The same step was repeated; where the same questionnaires were administered and this was followed by the 3rd counselling session. Each time, the evaluation was done first followed by repeated counselling using the module as a guide.

CONTROL GROUP

-A baseline evaluation was done using a set of validated and pretested questionnaires- Patients were given basic explanation on chemotherapy side-effects depending on the pharmacist own knowledge.

-Patients were followed up according to their appointment date. -The same questionnaires were then distributed again for their next chemotherapy cycle

-This step was repeated consecutively for the 2nd and 3rd evaluation. Throughout the evaluation no counselling was done, unless there were any questions asked which were addressed based on the pharmacists’ knowledge.

VARIABLES

Independent variables

Intervention Module (those receiving and not receiving the module)

Dependent variables

Physical effects due to chemotherapy;

(nausea; vomiting)

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INSTRUMENT

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QUESTIONNAIRE VALIDATED ADVERSE EVENT

National Cancer Institute Common Toxicity Criteria version 4.0,

National Cancer InstituteCommon Terminology Criteria for Adverse Events v4.0 NCI, NIH, DHHS. May 29, 2009

Trotti, A., Byhardt, R., Stetz, J., Gwede, C., Karen, F.C., Gunderson,L., McCormick,B., Morris∫, M., Rich, T., International Journal of Radiation Oncology*Biology*Physics. 47(1): 13-47

SCORE SEVERITY

0 NO

1 MILD

2 MODERATE

3 SEVERE

4 LIFE TREATENING

Validity and ReliabilityInstrument : Validity of Module and QuestionnaireInstrument : Reliability of Questionnaire• Reliability of the questionnaire was measured by checking the internal consistency

using Cronbach’s Alpha and values above 0.7 were considered as acceptable and shown in Table 1 below.

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Instrument Number of items Cronbach’s AlphaPhysical effects * 2 0.70

*

*Physical effects: (nausea, vomiting)

ETHICS APPROVAL• Medical Research Ethics Committee of Faculty of

Medicine and Health Sciences, Universiti Putra Malaysia

• National Medical Research Register (NMRR)• Permission from Hospital Tuankku Ja’afar,

Seremban and Hospital Tuanku Ampuan Najihah, Kuala Pilah before commencement of the study and pilot test

• Patient information sheet that explained the purpose of the study and other informations (risk, benefits) was given to patients and written consent was obtained prior to data collection.

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DATA ANALYSISData was analyzed using Statistical Package for Social Sciences Software, version 21.0. Level of significance of p<0.05.

•Data was tested for normality.

•Descriptive analysis: mean, standard deviation and 95% confidence interval.

•Inferential analysis was carried out using independent t-test for comparison of mean differences of scores and chi square. McNemar's test was used to determine two sample proportions for detecting changes in responses due to intervention •One way ANOVA (to look at the group main effect)•Two-way repeated measures ANOVA test was employed to look at the main and interaction effects within and between means scores for physical effects (nausea and vomiting), on each chemotherapy counseling session. It used partial eta squared (η2) as a measure of effect size.

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RESULTS

Response rate :

161patients out of 162 giving a response rate of 99.38%.

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Characteristics Frequency, n (%) Total Test p valueIntervention group Control group

1.Age< 4545-5455-64> 64TotalMean, SD95%CI

8(9.9)14(17.3)21(25.9)38(46.9)81(100)

67.46(1.38)(66.08-68.84)

13(16.3)15(18.8)27(33.8)25(31.1)80(100)

63.52(1.43)(62.09-64.95)

21(13.1)29(18.0)48(29.8)63(39.1)161(100)

65.49(1.41)(64.08-66.90)

χ2

t 0.1680.219

2.Gender Male Female

34(42.0)47(58.0)

42(52.5)38(47.5)

76(47.2)85(52.8)

χ2 0.181

3.Race Malay Chinese Indian Others

44(54.3)22(27.2)14(17.3)

1(1.2)

40(50.0)26(32.5)10(12.5)

4(5.0)

84(52.2)48(29.8)24(14.9)

5(3.1)

χ2 0.394

4.Religion Islam Buddha Hindu Christian Others No Religion

44(54.3)22(27.2)14(17.3)

1(1.2)0(0)0(0)

40(50.0)26(32.5)10(12.5)

3(3.8)1(1.2)0(0)

84(52.2)48(29.8)24(14.9)

4(2.5)1(0.6)0(0)

χ2 0.527

5.Marital Status Single Married Widowed Divorced Separate

8(9.9)54(66.7)10(12.3)

5(6.2)4(4.9)

3(3.8)62(77.5)11(13.7)

2(2.5)2(2.5)

11(6.9)116(72.1)21(13.0)

7(4.3)6(3.7)

χ2 0.306

Table 2: Socio- demographic characteristics of patients (n=161)

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Characteristics Frequency, n (%) Total Test p valueIntervention group Control group

6.Number of Children No Child 1-2 3-4 >4

11(13.6)

26(32.1)23(28.4)21(25.9)

7(8.8)

27(33.7)31(38.7)15(18.8)

18(11.2) 53(32.9)

54(33.5) 36(22.4)

χ2 0.490

7. Number of Family member Living Together None 1-2 3-4 >4

7(8.6)20(24.7)18(22.3)36(44.4)

7(8.8)17(21.2)23(28.8)33(41.2)

14(8.6)37(23.0)41(25.5)69(42.9)

χ2 0.902

8. Education level Primary Secondary University None

15(18.5)32(39.5)16(19.8)18(22.2)

18(22.5)23(28.8)17(21.2)22(27.5)

33(20.5)55(34.2)33(20.5)40(24.8)

χ2 0.538

9. Working Yes No Retired

32(39.5)33(40.7)16(19.8)

27(33.8)28(35.0)25(31.2)

59(36.6)61(37.9)41(25.5)

χ2 0.246

10.Monthly Income No income < 1501 1501-3500 >3500

33(40.7)14(17.3)22(27.2)12(14.8)

28(35.0)18(22.5)16(20.0)18(22.5)

61(37.9)32(19.9)38(23.6)30(18.6)

χ2 0.381


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Characteristics Frequency, n (%) Total Test p value

Intervention group Control group

11. Cancer Type Breast Colorectal Cervical Ovarian Lymphoma Stomach Others

30(37.0)23(28.4)7(8.8)4(4.9)4(4.9)6(7.4)7(8.6)

18(22.5)25(31.2)8(10.0)3(3.8)6(7.5)

10(12.5)10(12.5)

48(29.8)48(29.8)15(9.3)7(4.3)10(6.3)16(9.9)17(10.6)

χ2 0.516

12. Cancer Stage Stage 1 Stage 2 Stage 3 Stage 4

7(8.6)

16(19.8)30(37.0)28(34.6)

9(11.2)

12(15.0)28(35.0)31(38.8)

16(9.9)

28(17.4)58(36.1)59(36.6)

χ2 0.792

13. Number of Chemo- therapy cycle 1st cycle 2nd cycle

49(60.5) 32(39.5)

47(58.8)33(41.2)

96(59.6)65(40.4)

.

χ2 0.418

14. Family History of Cancer Yes No

42(51.9)39(48.1)

32(40.0)48(60.0)

74(46.0)87(54.0)

χ2 0.131


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Characteristics Frequency, n (%) Total Test p value

Intervention group

Control group

16. Treated with antidepressant Yes No

5(6.2)76(93.8)

9(11.2)71(88.8)

14(8.7)147(91.3)

FET 0.194

17. Alternative Medication Yes No

8(9.9)73(90.1)

8(10.0)72(90.0)

16(9.9)145(90.1)

FET 0.539

18. Hormone Medication Yes No

27(33.3)54(66.7)

20(25.0)60(75.0)

47(29.2)114(70.8)

χ2 0.245

19.Joined Cancer Support Society Yes No

5(6.2)76(93.8)

1(1.2)79(98.8)

6(3.7)155(96.3)

FET 0.108

Chi square test (χ2), Independent t test (t)*Significant at p <0.05


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Outcome measures

Mean score(SD) p-value

Overall Intervention Control

Physical effects

Nausea 1.18(1.10) 1.21(1.11) 1.15(1.09) 0.731

Vomiting 1.45(1.10) 1.48(1.12) 1.41(1.08) 0.692

Table 6 : Baseline comparison on mean scores of physical effects (nausea and vomiting) due to chemotherapy treatment for cancer patients between the

intervention and control group

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Table 7 : Baseline comparison of physical effects (nausea and vomiting) due to chemotherapy treatment for cancer patients between the intervention and control group.

Outcome measures Frequency, n (%) Total pa valueIntervention group Control

Group

Physical Effects1. Nausea None Mild Moderate Severe Life- Threatening

28(34.6)23(28.4)18(22.2)12(14.8)

0(0)

30(37.5)20(25.0)18(22.5)12(15.0)

0(0)

58(36.0)43(26.7)36(22.4)24(14.9)

0(0)

0.885

2. Vomiting None Mild Moderate Severe Life-Threatening

19(23.5)23(28.4)22(27.1)15(18.5)

2(2.5)

20(25.0)23(28.8)22(27.5)14(17.5)1(1.2)

39(24.2)46(28.6)44(27.3)29(18.0)

3(1.9)

0.984

PHYSICAL EFFECTS

NAUSEA

Nausea Frequency, n (%) Change (%)

p value

Baseline 1st counselling

None 28(34.6) 31(38.3) 3.7 0.019*

Mild 23(28.4) 25(20.9) -7.5Moderate 18(22.2) 15(18.5) -3.7

Severe 12(14.8) 10(12.3) -2.5Life threatening 0(0) 0(0) 0.0

Baseline 2nd counselling

None 28(34.6) 33(40.7) 6.1 0.001*Mild 23(28.4) 26(32.1) 3.7Moderate 18(22.2) 14(17.3) -4.9Severe 12(14.8) 8(9.9) -4.9

Life threatening 0(0) 0(0.0) 0.0

Baseline 3rd counsellingNone 28(34.6) 38(46.9) 12.3 0.001*Mild 23(28.4) 27(33.3) 4.9

Moderate 18(22.2) 10(12.3) -9.9Severe 12(14.8) 6(7.4) -7.4Life threatening 0(0) 0(0.0) 0.0

Table 8a Change in physical effects: NAUSEA in the intervention group

p value was calculated using a Mc Nemar test*Significant at p < 0.05

Table 8a Change in physical effects: NAUSEA in the intervention group

Nausea Frequency, n (%) Change(%)

p value

1st counselling 2nd counselling

None 31(38.3) 33(40.7) 2.4 0.001*

Mild 25(20.9) 26(32.1) 11.2

Moderate 15(18.5) 14(17.3) -1.2

Severe 10(12.3) 8(9.9) -2.4


1st counselling 3rd counselling

None 31(38.3) 38(46.9) 8.6 0.001*

Mild 25(20.9) 27(33.3) 12.4

Moderate 15(18.5) 10(12.3) -6.2

Severe 10(12.3) 6(7.4) -4.9


2nd counselling 3rd counselling

None 33(40.7) 38(46.9) 6.2 0.001*

Mild 26(32.1) 27(33.3) 1.2

Moderate 14(17.3) 10(12.3) -5.0

Severe 8(9.9) 6(7.4) -2.5

Life threatening 0(0.0) 0(0.0) 0.0


Nausea Frequency, n (%) Change(%)

p value

Baseline 1st follow-up

None 30(37.5) 17(21.2) -16.3 0.001*

Mild 20(25.0) 23(28.8) 3.8

Moderate 18(22.5) 21(26.2) 3.7

Severe 12(15.0) 19(23.8) 8.8

Life threatening 0(0.0) 0(0) 0.0

Baseline 2nd follow-up

None 30(37.5) 11(13.8) -23.7 0.001*

Mild 20(25.0) 27(33.8) 8.8

Moderate 18(22.5) 21(26.2) 3.7

Severe 12(15.0) 21(26.2) 11.2


Baseline 3rd follow-up

None 30(37.5) 1(1.2) -36.3 0.001*

Mild 20(25.0) 28(35.0) 10.0

Moderate 18(22.5) 25(31.2) 8.7

Severe 12(15.0) 26(32.6) 17.6



Table 8b Change in physical effects: NAUSEA in the control group

Table 8b Change in physical effects: NAUSEA in the control group

Nausea Frequency, n (%) Change (%) p value

1st follow-up 2nd follow-up

None 17(21.2) 11(13.8) -7.4 0.017*

Mild 23(28.8) 27(33.8) 5.0

Moderate 21(26.2) 21(26.2) 0

Severe 19(23.8) 21(26.2) 2.4

Life threatening 0(0) 0(0) 0.0

1st follow-up 3rd follow-upNone 17(21.2) 1(1.2) -20 0.001*

Mild 23(28.8) 28(35.0) 6.2

Moderate 21(26.2) 25(31.2) 5.0

Severe 19(23.8) 26(32.6) 8.8


2nd follow-up 3rd follow-upNone 11(13.8) 1(1.2) -12.6 0.001*

Mild 27(33.8) 28(35.0) 1.2

Moderate 21(26.2) 25(31.2) 5.0

Severe 21(26.2) 26(32.6) 6.4



Table 8c Group main effect on Nausea at baseline, 1st follow-up, 2nd follow-up and 3rd follow-up

Outcome measures Mean ± SD (95%CI) F p value

Intervention group (n =81)

Control group (n= 80)

Nausea One way ANOVA

Baseline 1.21 ± 1.11(0.96-1.46) 1.15 ± 1.09(0.91-1.39) 0.015 0.731

1st follow-up 1.09 ± 1.09(0.85-1.33) 1.58± 1.17(1.32-1.83) 7.565 0.007*

2nd follow-up 0.96± 0.99(0.74-1.18) 1.70 ± 1.11(1.45-1.95) 19.787 0.001*

3rd follow-up 0.80± 0.93(0.60-1.01) 2.01± 0.96(1.80-2.23) 66.066 0.001*

*Significant at p < 0.05

Table 8d Summary table of two way repeated measures ANOVA for Nausea

Source Type III Sum of Squares

df Mean square

F p value PartialȠ2

Nausea

Group 56.793 1 56.793 13.496 0.001* 0.078

Error(Between) 669.095 159 4.208

Time 4.393 2.640 1.664 15.875 0.001* 0.091

Group*Time 33.753 2.640 12.786 121.976 0.001* 0.434

Error (within) 43.998 419.733 0.105

*Significant at p<0.05

F

Figure 3 The interaction plot between group and time for means of Nausea

Table 8e Multiple pair wise comparisons of Nausea for the Intervention group

Group – time comparisonPairs

Meandifference

95% CI formean

difference

p value

Pair 1Baseline vs 1st follow-up 0.123 0.024 - 0.223 0.007*

Pair 2

Baseline vs 2nd follow-up 0.247 0.116 - 0.377 0.001*

Pair 3

Baseline vs 3rd follow-up 0.407 0.259 – 0.556 0.001*

Pair 4

1st follow-up vs 2nd follow-up 0.123 0.024 – 0.223 0.007*

Pair 5

1st follow-up vs 3rd follow-up 0.284 0.148 – 0.420 0.001*

Pair 6

2nd follow-up vs 3rd follow-up 0.160 0.049 – 0.272 0.001*

Adjustment for multiple comparisons using Bonferroni test

Table 8f Multiple pair wise comparisons of Nausea for the control group

Adjustment for multiple comparisons using Bonferroni test*Significant at p < 0.05


Meandifference

95% CI formean

difference

p value

Pair 1Baseline vs 1st follow-up -0.425 -0.576 – (-0.274) 0.001*

Pair 2

Baseline vs 2nd follow-up -0.550 -0.701 – (-0.399) 0.001*

Pair 3

Baseline vs 3rd follow-up -0.863 -0.978 – (-0.747) 0.001*

Pair 4

1st follow-up vs 2nd follow-up -0.125 -0.226 – (-0.024) 0.007*

Pair 5

1st follow-up vs 3rd follow-up -0.438 -0.589 – (-0.286) 0.001*

Pair 6

2nd follow-up vs 3rd follow-up -0.313 -0.454 – (-0.171) 0.001*

PHYSICAL EFFECTS

VOMITING

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Table 9a Change in physical effects: VOMITING in the intervention group


Vomiting Frequency, n (%) Change (%)

p value

Baseline 1st counselling

None 19(23.5) 23(28.4) 4.9 0.001*

Mild 23(28.3) 26(32.1) 3.8

Moderate 22(27.2) 20(24.7) 2.5

Severe 15(18.5) 10(12.3) -6.2

Life threatening 2(2.5) 2(2.5) 0.0

Baseline

2nd counselling

None 19(23.5) 24(29.6) 6.1 0.001*

Mild 23(28.3) 27(33.4) 5.1

Moderate 22(27.2) 19(23.5) -3.7

Severe 15(18.5) 10(12.3) -6.2

Life threatening 2(2.5) 1(1.2) -1.3

Baseline 3rd counselling

None 19(23.5) 38(46.9) 14.5 0.001*

Mild 23(28.3) 27(33.4) 5.1

Moderate 22(27.2) 10(12.3) -14.9

Severe 15(18.5) 6(7.4) -11.1


Table 9a Change in physical effects: VOMITING in the intervention group


Vomiting Frequency, n (%) Change(%)

p value

1st counseling 2nd counselling

None 23(28.4) 24(29.6) 1.2 0.001*

Mild 26(32.1) 27(33.4) 1.3

Moderate 20(24.7) 19(23.5) -1.2

Severe 10(12.3) 10(12.3) 0


1st counselling 3rd counselling

None 23(28.4) 38(46.9) 18.5 0.001*

Mild 26(32.1) 27(33.4) 1.3

Moderate 20(24.7) 10(12.3) -12.4

Severe 10(12.3) 6(7.4) -4.9


2nd counselling 3rd counselling

None 24(29.6) 38(46.9) 17.3 0.001*

Mild 27(33.4) 27(33.4) 0

Moderate 19(23.5) 10(12.3) -11.2

Severe 10(12.3) 6(7.4) -4.9



Table 9b Change in physical effects: VOMITING in the control group

Vomiting Frequency, n (%) Change(%)

p value

Baseline 1st follow-up

None 20(25.0) 17(21.2) -3.8 0.029*

Mild 23(28.8) 23(28.8) 0Moderate 22(27.5) 22(27.5) 0Severe 14(17.5) 17(21.3) 3.8Life threatening 1(1.2) 1(1.2) 0.0

Baseline 2nd follow-upNone 20(25.0) 13(16.2) -8.8 0.001*Mild 23(28.8) 25(31.3) 2.5Moderate 22(27.5) 22(27.5) 0Severe 14(17.5) 19(23.8) 6.3Life threatening 1(1.2) 1(1.2) 0

Baseline 3rd follow-upNone 20(25.0) 10(12.5) -12.5 0.001*Mild 23(28.8) 27(33.8) 5.0Moderate 22(27.5) 22(27.5) 0Severe 14(17.5) 19(23.8) 6.3Life threatening 1(1.2) 2(2.5) 1.3

Table 9b Change in physical effects: VOMITING in the control group


Vomiting Frequency, n (%) Change (%) p value

1st follow-up 2nd follow-up

None 17(21.2) 13(16.2) -5.0 0.046*

Mild 23(28.8) 25(31.2) 2.4Moderate 22(27.5) 22(27.5) 0Severe 17(21.2) 19(23.8) 2.6Life threatening 1(1.2) 1(1.2) 0

1st follow-up 3rd follow-upNone 17(21.2) 10(12.5) -8.7 0.007*Mild 23(28.8) 27(33.8) 5.0Moderate 22(27.5) 22(27.5) 0Severe 17(21.2) 19(23.8) 2.6Life threatening 1(1.2) 2(2.5) 1.3

2nd follow-up 3rd follow-upNone 13(16.2) 10(12.5) -3.7 0.199Mild 25(31.2) 27(33.8) 2.6Moderate 22(27.5) 22(27.5) 0Severe 19(23.8) 19(23.8) 0Life threatening 1(1.2) 2(2.5) 1.3

Table 9c Group main effect on VOMITING at baseline, 1st follow-up, 2nd follow-up and 3rd follow-up

Outcome measures Mean ± SD (95%CI) F p value

Intervention group (n =81)

Control group (n= 80)

Vomiting One way ANOVA

Baseline 1.48 ± 1.12(1.23-1.73) 1.41 ± 1.09(1.17-1.65) 0.157 0.692

1st follow-up 1.28 ± 1.09(1.04-1.52) 1.53± 1.09(1.28-1.77) 1.973 0.162

2nd follow-up 1.22± 1.05(0.99-1.45) 1.63 ± 1.06(1.39-1.86) 5.874 0.016*

3rd follow-up 0.80 ± 0.93(0.60-1.01) 1.70 ± 1.05(1.47-1.93) 33.123 0.001*

*Significant at p < 0.05

Table 9d Summary table of two way repeated measures ANOVA for VOMITING

*Significant at p<0.05

Source Type III Sum of Squares

df Mean square

F p value PartialȠ2

Vomiting

Group 21.814 1 21.814 5.133 0.025* 0.031

Error(Between) 675.730 159 4.250

Time 3.793 2.466 1.538 15.588 0.001* 0.089

Group*Time 19.669 2.466 7.794 80.833 0.001* 0.337

Error (within) 38.688 392.079 0.099

F

Figure 4 The interaction plot between group and time for means of VOMITING

Table 9e Multiple pair wise comparisons of VOMITING for the Intervention group



Meandifference

95% CI formean

difference

p value

Pair 1Baseline vs 1st follow-up 0.198 0.077- 0.318 0.001*

Pair 2

Baseline vs 2nd follow-up 0.259 0.127 - 0.392 0.001*

Pair 3

Baseline vs 3rd follow-up 0.679 0.530 – 0.828 0.001*

Pair 4

1st follow-up vs 2nd follow-up 0.062 -0.011 – 0.135 0.146

Pair 5

1st follow-up vs 3rd follow-up 0.481 0.330 – 0.633 0.001*

Pair 6

2nd follow-up vs 3rd follow-up 0.420 0.270 – 0.569 0.001*

Table 9f Multiple pair wise comparisons of VOMITING for the control group



Meandifference

95% CI formean

difference

p value

Pair 1Baseline vs 1st follow-up -0.112 -0.209 – (-0.016) 0.013*

Pair 2

Baseline vs 2nd follow-up -0.212 -0.337 – (-0.088) 0.001*

Pair 3

Baseline vs 3rd follow-up -0.287 -0.425 – (-0.150) 0.001*

Pair 4

1st follow-up vs 2nd follow-up -0.100 -0.191– (-0.009) 0.024*

Pair 5

1st follow-up vs 3rd follow-up -0.175 -0.291 – (-0.059) 0.001*

Pair 6

2nd follow-up vs 3rd follow-up -0.075 -0.155 – (-0.005) 0.080

DISCUSSIONAssociation between PHYSICAL EFFECTS and effectiveness of chemotherapy counselling

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Association between

PHYSICAL EFFECTS

This Study

Other Studies DiscussionResearcher Finding

Nausea , Vomiting

Yes Liekweg, et al., 2004;Wu, et al., 2005

Yes Need for the pharmacist involvement grew significantly with the shift from a disease-centered to a patient-centered care

Education for caregivers and cancer patients given with information on the available effective strategies helps improve nausea and vomiting

LIMITATIONS

• Time Constraint

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CONCLUSION

• Chemotherapy counselling module developed for pharmacist together with repetitive counselling was effective among oncology patients receiving chemotherapy in reducing nausea and vomiting

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RECOMMENDATIONS• A multisite study is recommended in order to

achieve a more heterogeneous group of population and to minimize cross contamination that would affect the internal validity of the study.

53

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