PDF of accompanying PowerPoint
Transcript of PDF of accompanying PowerPoint
The FOCUS Program:The FOCUS Program:Helping Cancer Patients and Family Helping Cancer Patients and Family
Their CaregiversTheir Caregivers
Laurel Northouse PhD, RN, FAANProfessor of Nursing
University of Michigan
Co-director, Socio-behavioral ProgramU of M Comprehensive Cancer Center
OverviewOverview
Significance of the Research
Description of the FOCUS Program
Results from Three Randomized Trials
Dissemination Plans
Significance of ResearchSignificance of Research
The effects of cancer extend from patients to family caregivers
Like a stone dropping in a pond …
Reciprocal Relationship in PartnersReciprocal Relationship in Partners’’Emotional Distress Emotional Distress
Patient r = .29 Spouse
Couples react as an “emotional system”
PatientsPatients’’ Symptoms Affect Spouses Symptoms Affect Spouses
As patients’ symptoms increase, spouses report a decrease in quality of life
Patient symptoms Spouse Effect
Urinary incontinence Social quality of life
Erectile dysfunction Sexual satisfaction
Fatigue Quality of life
Emotional Toll on Spouse CaregiversEmotional Toll on Spouse Caregivers
Spouses report more symptoms of depression than patients in advanced phase of illness
Clinical Depression p valuePatients 23% <.0001Spouses 39%
Braun et al. JCO 2007
Why Help Family Caregivers of Why Help Family Caregivers of Cancer Patients?Cancer Patients?
Affected by illness -- “co-suffers”
Lack preparation for caregiving role
Little support from health professionals
Distressed caregiver hinders patient’s adjustment
Description of the FOCUS ProgramDescription of the FOCUS Program
q
Delivered by a Masters-prepared nurse
Core Program Content Core Program Content
F = Family Involvement
O = Optimistic Attitude
C = Coping Effectiveness
U = Uncertainty Reduction
S = Symptom Management
F = Family InvolvementF = Family Involvement
Promote open communicationEncourage mutual support and teamworkIdentify family strengthsHelp children in the family to cope
Promote Family CommunicationPromote Family Communication
O = Optimistic AttitudeO = Optimistic Attitude
Encourage optimistic thinkingSharing fears and negative thoughtsMaintaining hope
Optimism BrochureOptimism Brochure
C = Coping EffectivenessC = Coping Effectiveness
Help them cope with stressEncourage healthy lifestyle behaviorsIdentify possible benefits of illness
Help Families CopeHelp Families Cope
U = Uncertainty ReductionU = Uncertainty Reduction
Provide information about treatments and medication
Teach them how to obtain information from professionals or other trusted sources
Help them live with uncertainty
S = Symptom ManagementS = Symptom Management
Assess symptoms in patient and family caregiver
Teach them self-care strategies
Teach Symptom Management
Treatment FidelityTreatment Fidelity
Nurses followed a 21-page protocol checklist of interventions
Nurses audio-taped randomly selected sessions
Nurses gave case presentations at monthly intervention meetings
Intervention TeamIntervention TeamMastersMasters--prepared Nursesprepared Nurses
Completed 42-hour training programViewed FOCUS training videoNew nurses accompanied experienced
nurses on home visits to learn roleNurses maintained own caseload of
couples
Evaluation of FOCUS ProgramEvaluation of FOCUS Program
Breast Cancer Clinical TrialAmerican Cancer Society
Prostate Cancer Clinical TrialNational Cancer Institute
Advanced Cancer Clinical TrialNational Cancer Institute
The FOCUS Study The FOCUS Study –– Initial TrialInitial Trial
Recurrent Breast Cancer Patients and Recurrent Breast Cancer Patients and Family CaregiversFamily Caregivers
Funded by AmericanCancer Society
Sample: 134 patientsand their caregivers
Purpose of StudyPurpose of Study
To test the effects of a family intervention (FOCUS Program) on patient and spouse outcomes
Appraisal variables
Coping resources
Quality of life
STRESSSTRESS--COPING FRAMEWORKCOPING FRAMEWORK
OutcomesMediatorsAntecedents
Factors• Person• Social• Disease treatment
Appraisal• Threat• Hopelessness• Uncertainty
Coping Resources
• CopingStrategies
Quality of Life
• Patient• Caregiver
FOCUS
Study DesignStudy DesignRandomized Clinical TrialRandomized Clinical Trial
Control Group Experimental Group
“Standard Care”“Standard Care”
+FOCUS Program
Eligible Couples
Random Assignment
Program DeliveryProgram Delivery
Initial Phase Booster Phase
HomeVisit
1
HomeVisit
2
HomeVisit
3
PhoneCall
1
PhoneCall
2
Study ResultsStudy ResultsIntervention Intervention vsvs ControlsControls
PatientsLess negative appraisal of illness F = 4.49, p = .04
Less hopelessness F = 9.48, p = .002
CaregiversLess negative view of caregiving F = 3.90, p = .04
Northouse et al., Psycho-Oncology, 2005
FOCUS Study FOCUS Study –– Second Trial Second Trial Adapted to Prostate CancerAdapted to Prostate Cancer
N = 222 dyads
Includes 3 phases of prostate cancer
Funded by the National Cancer InstituteFunded by the National Cancer Institute
STRESSSTRESS--COPING FRAMEWORKCOPING FRAMEWORK
OutcomesMediatorsAntecedents
Factors• Person• Social• Disease treatment
Appraisal• Threat• Hopelessness• Uncertainty
Coping Resources
• Coping strategy• Self-efficacy• Communication
Quality of Life
• Patient• Caregiver
FOCUS
Study DesignStudy DesignRandomized Clinical TrialRandomized Clinical Trial
Control Group Experimental Group
“Standard Care”“Standard Care”
+FOCUS Program
Eligible Couples
Random Assignment
Stratified by:• Research Site• Phase of Illness• Treatment
FOCUSProgram
Phone Call
Delivered over three-month period
Revised Program Delivery
Phone Call
Home visit
Homevisit
Home visit
5 contacts
Longitudinal AssessmentsLongitudinal Assessments
Baseline 4 mo. 8 mo. 12 mo.Time 1 Time 2 Time 3 Time 4
Interventionor
Control
Prostate Study Results: PatientsProstate Study Results: PatientsIntervention Intervention vsvs ControlsControls
Less uncertainty F = 3.69, p = .03
Better communication F = 3.48, p = .03
Higher quality of life F = 3.21, p = .07
No differences: appraisal of illness, hopelessness, symptoms, or self-efficacy
Northouse et al. Cancer, 2007
Prostate Study Results: SpousesProstate Study Results: SpousesIntervention Intervention vsvs ControlsControls
Less negative appraisal F = 8.54, p = .002
Less hopelessness F = 4.15, p = .03
Less uncertainty F = 7.43, p = .009
More self-efficacy F = 3.83, p = .02
Better communication F = 9.71, p = .002
Higher quality of life F = 8.91, p = .004
Satisfaction with InterventionSatisfaction with Intervention
Patients’ mean satisfaction score = 4.5
Spouses’ mean satisfaction score = 4.5
Satisfaction Scores1————————————————5
low high
What did we learn?What did we learn?
Both patients and caregivers benefit from an intervention
Some participants need the intervention more than others
Rethink the “one-size-fits-all”interventions
Examine risk-for-distress and intervention dose
Current StudyCurrent StudyRisk for Distress and Intervention DoseRisk for Distress and Intervention Dose
Aim 1. Compare two doses of family intervention vs. control
Aim 2. Examine effect of patient “risk for distress”on study outcomes
Current Study Design
Screening for Risk for DistressScreening for Risk for Distress
Assesses risk of future emotional distress
A multi-dimensional scale
Predicted high and low distress in 73% of patients screened at baseline
Determining Risk StatusDetermining Risk Status
Range of Risk for Distress Scores0 ———————————————— 24low high
8 and below
9 and above
Preliminary results from current study: Range of RFD scores: 1 to 19
SampleSample
Advanced cancer patients and caregiversTarget: 475 patient-caregiver dyadsCurrently enrolled: 440 dyads
Enrollment rate: Overall 68% Retention rate: 69%
Data Collection and Intervention
Study Still in ProgressStudy Still in Progress
Enrollment should be completed May, 2009Results of Randomized Clinical Trial
available in Fall, 2009.
Translation Efforts to DateTranslation Efforts to Date
Prostate FOCUS program will be available on NCI Cancer Planet web-site (coming soon)
• Intervention protocol• Staff training manual• All brochures and handouts
Plans to translate program to tailored web-based program
Future Dissemination Plans:Future Dissemination Plans:FOCUS ProgramFOCUS Program
Research funding to facilitate translation to clinical and community settings
Analysis of cost savings and cost of delivery
Consider application to other chronic illnesses
SummarySummary
Testing family-based interventionsIdentifying families at risk of distressExamining intervention doseTranslating intervention to practice