The FOCUS Program: Helping Cancer Patients and Family Their Caregivers. Laurel Northouse PhD, RN, FAAN Professor of Nursing University of Michigan
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1 The FOCUS Program: Helping Cancer Patients and Family Their Caregivers Laurel Northouse PhD, RN, FAAN Professor of Nursing University of Michigan Co-director, Socio-behavioral Program U of M Comprehensive Cancer Center
2 Overview Significance of the Research Description of the FOCUS Program Results from Three Randomized Trials Dissemination Plans
3 Significance of Research The effects of cancer extend from patients to family caregivers Like a stone dropping in a pond
4 Reciprocal Relationship in Partners Emotional Distress Patient r =.29 Spouse Couples react as an emotional system
5 Patients Symptoms Affect Spouses As patients symptoms increase, spouses report a decrease in quality of life Patient symptoms Urinary incontinence Erectile dysfunction Fatigue Spouse Effect Social quality of life Sexual satisfaction Quality of life
6 Emotional Toll on Spouse Caregivers Spouses report more symptoms of depression than patients in advanced phase of illness Clinical Depression p value Patients 23% <.0001 Spouses 39% Braun et al. JCO 2007
7 Why Help Family Caregivers of Cancer Patients? Affected by illness -- co-suffers Lack preparation for caregiving role Little support from health professionals Distressed caregiver hinders patient s adjustment
8 Description of the FOCUS Program q Delivered by a Masters-prepared nurse
9 Core Program Content F = Family Involvement O = Optimistic Attitude C = Coping Effectiveness U = Uncertainty Reduction S = Symptom Management
10 F = Family Involvement Promote open communication Encourage mutual support and teamwork Identify family strengths Help children in the family to cope
11 Promote Family Communication
12 O = Optimistic Attitude Encourage optimistic thinking Sharing fears and negative thoughts Maintaining hope
13 Optimism Brochure
14 C = Coping Effectiveness Help them cope with stress Encourage healthy lifestyle behaviors Identify possible benefits of illness
15 Help Families Cope
16 U = 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
17 S = Symptom Management Assess symptoms in patient and family caregiver Teach them self-care strategies
18 Teach Symptom Management
19 Treatment Fidelity Nurses followed a 21-page protocol checklist of interventions Nurses audio-taped randomly selected sessions Nurses gave case presentations at monthly intervention meetings
20 Intervention Team Masters-prepared Nurses Completed 42-hour training program Viewed FOCUS training video New nurses accompanied experienced nurses on home visits to learn role Nurses maintained own caseload of couples
21 Evaluation of FOCUS Program Breast Cancer Clinical Trial American Cancer Society Prostate Cancer Clinical Trial National Cancer Institute Advanced Cancer Clinical Trial National Cancer Institute
22 The FOCUS Study Initial Trial Recurrent Breast Cancer Patients and Family Caregivers Sample: 134 patients and their caregivers Funded by American Cancer Society
23 Purpose of Study To test the effects of a family intervention (FOCUS Program) on patient and spouse outcomes Appraisal variables Coping resources Quality of life
24 STRESS-COPING FRAMEWORK Antecedents Mediators Outcomes Factors Person Social Disease treatment F O C U S Appraisal Threat Hopelessness Uncertainty Coping Resources Coping Strategies Quality of Life Patient Caregiver
25 Study Design Randomized Clinical Trial Eligible Couples Random Assignment Control Group Standard Care Experimental Group Standard Care + FOCUS Program
26 Program Delivery Initial Phase Booster Phase Home Visit 1 Home Visit 2 Home Visit 3 Phone Call 1 Phone Call 2
27 Study Results Intervention vs Controls Patients Less negative appraisal of illness F = 4.49, p =.04 Less hopelessness F = 9.48, p =.002 Caregivers Less negative view of caregiving F = 3.90, p =.04 Northouse et al., Psycho-Oncology, 2005
28 FOCUS Study Second Trial Adapted to Prostate Cancer N = 222 dyads Includes 3 phases of prostate cancer Funded by the National Cancer Institute
29 STRESS-COPING FRAMEWORK Antecedents Mediators Outcomes Factors Person Social Disease treatment F O C U S Appraisal Threat Hopelessness Uncertainty Coping Resources Coping strategy Self-efficacy Communication Quality of Life Patient Caregiver
30 Study Design Randomized Clinical Trial Eligible Couples Stratified by: Research Site Phase of Illness Treatment Control Group Random Assignment Experimental Group Standard Care Standard Care + FOCUS Program
31 Revised Program Delivery FOCUS Program 5 contacts Home visit Phone Call Home visit Phone Call Home visit Delivered over three-month period
32 Longitudinal Assessments Baseline 4 mo. 8 mo. 12 mo. Time 1 Time 2 Time 3 Time 4 Intervention or Control
33 Prostate Study Results: Patients Intervention vs Controls 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
34 Prostate Study Results: Spouses Intervention vs Controls 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
35 Satisfaction with Intervention Satisfaction Scores 1 5 low high Patients mean satisfaction score = 4.5 Spouses mean satisfaction score = 4.5
36 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
37 Current Study Risk 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
38 Current Study Design
39 Screening 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
40 Determining Risk Status Range of Risk for Distress Scores 0 24 low high 8 and below 9 and above Preliminary results from current study: Range of RFD scores: 1 to 19
41 Sample Advanced cancer patients and caregivers Target: 475 patient-caregiver dyads Currently enrolled: 440 dyads Enrollment rate: Overall 68% Retention rate: 69%
42 Data Collection and Intervention
43 Study Still in Progress Enrollment should be completed May, 2009 Results of Randomized Clinical Trial available in Fall, 2009.
44 Translation 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 webbased program
45 Future Dissemination Plans: FOCUS 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
46 Summary Testing family-based interventions Identifying families at risk of distress Examining intervention dose Translating intervention to practice
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