Northouse,L.L.; Mood,D.W.; Schafenacker,A.; Montie,J.E.; Sandler,H.M.; Forman,J.D.; Hussain,M.; Pienta,K.J.; Smith,D.C.; Kershaw,T.; . (2007). Randomized clinical trial of a family intervention for prostate cancer patients and their spouses. Cancer, 110(12), 2809-2818.
Designed to enhance the quality of life of men diagnosed with prostate cancer and their spouses/partners, this couples-based intervention provides tailored support through three home visits and two telephone counseling sessions that address family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. The study showed decreased uncertainty and increased communication between patients and their spouses/partners.
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Prostate cancer is the most common cancer among men, accounting for 33% of all cancers diagnosed in American males. Available treatments for this form of cancer often have devastating side effects that can negatively impact the patient's quality of life. Side effects may include erectile dysfunction, urinary incontinence, bowel dysfunction, fatigue, hot flashes, and loss of muscle mass. The quality of life of spouses/partners, who are most likely to be the primary caregiver, is also affected by the illness. Research has shown that spouses of men with prostate cancer report feeling emotionally distressed and have problems with fatigue, tension, and decreases in their own sexual interest. Spouses' emotional distress may be attributed to their feelings of uncertainty, low self-efficacy in managing the effects of the illness, communication problems with their partner, and insufficient support from others. Research also has shown that spouses often display greater levels of distress than their husbands.
Studies have shown that spouses' inability to deal with distress is related not only to their own quality of life, but also that of the patient. Yet, to date, very few intervention programs have been created to help prostate cancer patients and their spouses cope with the effects of the illness and side effects from treatment. In addition, while some programs have addressed the needs of prostate cancer patients during the newly diagnosed phase of their illness, none have looked at their needs during the biochemical recurrence phase (post-treatment with rising prostate-specific antigen, PSA) or advanced phase.
The FOCUS Program is a couples-based intervention designed to help improve the quality of life for men with prostate cancer and their spouses/partners during all phases of the illness. This is accomplished by providing the couples with information and support through home visits and telephone counseling sessions conducted by trained nurses. Several core components are covered by the FOCUS Program, all aimed at teaching prostate cancer patients and their spouses/partners skills to help improve their overall quality of life. The content of the core areas is represented by the acronym FOCUS: Family involvement, Optimistic attitude, Coping effectiveness, Uncertainty reduction, and Symptom management. Specifically, program content includes: spouse/partner involvement, which encourages couples to work as a team, communicate openly about the illness, and provide one another with support; optimistic attitude, which helps couples maintain hope and focus on achievable short-term goals; coping effectiveness, which emphasizes techniques to reduce stress, active coping strategies, and healthy lifestyle behaviors; uncertainty reduction, which teaches couples how to obtain information and ways to live with uncertainty; and symptom management, which offers self-care strategies for managing symptoms.
The FOCUS Program consists of three 90-minute home visits and two 30-minute telephone sessions facilitated by master's-level nurses. While the program has core components, each session is tailored to fit the needs of couples in their particular phase of illness. The sessions address individual psychosocial as well as dyad/family concerns that are not usually addressed in standard care.
During each home visit, the nurse first assesses the couple's current functioning in the core areas. The nurse then educates the couple as to ways they can improve the areas in which they need assistance and acknowledges their strengths in the areas in which they are doing well. The nurse also provides an opportunity for the couple to ask questions and discuss their concerns. Informational booklets and other educational materials are provided during the session.
During the telephone sessions, the nurse conducts an updated assessment of the couple's functioning, provides an opportunity for the couple to ask questions and discuss their concerns, encourages positive coping strategies, and helps to problem-solve difficulties the couple has encountered.
The FOCUS Program includes 40 hours of training for master's-level nurses who administer the program to prostate cancer patients and their spouses. Nurses were required to view a training video and shadow experienced nurses before taking on their own caseload. The intervention itself consists of three structured 90-minute home visits and two 30-minute telephone sessions that occur between home visits. Sessions take place over a 4-month period, and both the patient and spouse/partner are required to attend each of the sessions together.
The primary audience for the FOCUS Program is men with prostate cancer and their spouses/partners.
The FOCUS Program is designed to be administered in patients' homes and by telephone. Patients may be recruited through medical establishments treating men with prostate cancer, such as surgery, radiation, and medical oncology clinics.
The FOCUS Program toolkit includes the following materials:
- FOCUS Intervention protocol manual (including the protocol for telephone sessions 2 and 4)
- The FOCUS Program: Intervention Program for Prostate Cancer Patients and Their Spouses/Partners Intervention Training Manual
- Overview of FOCUS Program Session 1
o Patient booklets
o Drug information sheets
o Symptom management cards
o Letting Go of Stress relaxation audiotape (by Emmett Miller)
- FOCUS Program Session 3
o Ten Commandments of Good Listening sheet
o Patient booklets
o Rhythmic Walking manual (by M. Winningham PhD, RN)
- FOCUS Program Session 5
o Patient booklets
o Referrals/brochures for community resources
- Working With Families of Cancer Patients (DVD)
About the Study
The sample consisted of 263 dyads, composed of patients with prostate cancer and their spouses, who were recruited from three large cancer centers in the Midwest. Patients were eligible if they were in one of three phases of illness: newly diagnosed, biochemical recurrence, or advanced. In addition, they had to be 30 years of age or older, have a life expectancy at least 12 months, have a spouse or cohabitating partner, and live within 75 miles of the participating cancer centers. Spouses or partners were eligible if they were 21 years of age or older, were identified by the patients as their primary caregiver, and had not been diagnosed with cancer within the prior year.
Patients were stratified by treatment center, phase of illness, and type of treatment, then randomized into control or experimental treatment groups along with their spouses. A team of master's-level nurses delivered the intervention and another team of nurses, who were blinded to group assignment, were responsible for data collection. Control group couples received standard clinic care, while those in the experimental group received standard clinic care plus the FOCUS Program, which consisted of three 90-minute home visits and two 30-minute telephone sessions with a master's-level nurse.
Data were collected at baseline and 4, 8, and 12 months after baseline. Of the 263 dyads who enrolled in the study, 235 (90%) completed the 4-month follow-up assessment, and 218 (83%) completed all 3 follow-up assessments. The final sample used for analyses consisted of 235 dyads (112 intervention, 123 control).
Participating couples completed questionnaires at baseline and at all three follow-up points. The following variables were assessed: quality of life (QOL), appraisal of illness, appraisal of caregiving, uncertainty, hopelessness, coping, self-efficacy, communication, general symptom distress, prostate-specific symptoms, and risk for distress. The instruments used to measure outcomes included:
- Medical Outcomes Study 12-item short form (MOS SF-12) - used to measure mental and physical QOL
- Functional Assessment of Cancer Treatment (FACT-G) - used to measure QOL
- Appraisal of Illness Scale - used to measure patients' appraisal of their illness
- Appraisal of Caregiving Scale - used to assess spouses' perception of caregiving
- Mishel Uncertainty in Illness Scale - used to measure uncertainty
- Beck Hopelessness Scale - used to measure hopelessness
- Brief COPE Scale - used to assess coping strategies
- Lewis Cancer Self-Efficacy Scale - used to measure self-efficacy
- Lewis Mutuality and Interpersonal Sensitivity Scale - used to assess communication
- Omega Screening Questionnaire - used to measure risk for distress
- 16-item Symptom Scale of the Omega Screening Questionnaire (OSQ) - used to measure general symptom distress
- Expanded Prostate Cancer Index Composite (EPIC) - used to measure prostate-specific symptoms
For quality assurance, intervention nurses (1) completed a 21-page protocol checklist that outlined interventions for each session; (2) recorded the percent of time they spent on the FOCUS components in each session; (3) audiotaped randomly selected home visits that were later reviewed for adherence to protocol guidelines; and (4) provided case presentations at monthly staff meetings. Thirty randomly selected protocol checklists were analyzed; 98.3% were found to adhere to study protocol.
Effects of the FOCUS Program on Uncertainty
- Among patients, mean scores for uncertainty at 4-month follow-up were 56.9 for the intervention group and 60 for the control group (p<.05). The range of scores was 28 to 140 for uncertainty. There were no significant differences between intervention and control group patients at 8- or 12-month follow-up.
- Among spouses/partners, mean scores for uncertainty at 4-month follow-up were 59.5 for the intervention group and 63.1 for the control group (p<.01). At 8-month follow-up, uncertainty continued to be significantly lower for spouses/partners in the intervention group, with means of 59.5 versus 62.2, respectively (p<.05). The range of scores was 28 to 140 for uncertainty. However, at 12-month follow-up, there was no significant difference between intervention and control group spouses/partners.
Effects of the FOCUS Program on Communication With Patient/Partner
- Among patients, mean scores for communication with spouse/partner at 4-month follow-up were 3.80 for the intervention group and 3.69 for the control group (p<.05). Intervention and control group patients' communication scores were not significantly different at the 8- or 12-month follow-up.
- Among spouses/partners, mean scores for communication with patient for the intervention and control groups were 3.74 and 3.57, respectively, at 4-month follow-up (p<.01), 3.66 and 3.52 at 8-month follow-up (p<.05), and 3.66 and 3.5 at 12-month follow-up (p<.01).
Effects of the FOCUS Intervention on Quality of Life for Spouse/Partner
- Quality of Life, both physical and mental, improved significantly for spouses/partners in the intervention group. At 4-month follow-up, mean scores on the MOS SF-12 Mental QOL measure were 50.9 for the intervention group and 49 for the control group (p<.05), while mean scores on the FACT-G were 86.5 for the intervention group and 83.5 for the control group (p<.01). At 8-month follow-up, scores on the MOS SF-12 Physical QOL measure were 44.9 for the intervention group and 42.9 for the control group (p<.05). At 12-month follow-up, scores on the MOS SF-12 Physical QOL measure were 44.6 for the intervention group and 42.3 for the control group (p<.01).
Effects of the FOCUS Intervention on Appraisal Variables for Spouse/Partner
- At 4-month follow-up, spouses in the intervention group showed significant improvement for all appraisal variables. Mean scores for appraisal of caregiving (which measures negative perceptions of caregiving) were 2.29 for the intervention group and 2.44 for the control group (p<.01). Mean scores for hopelessness were 2.47 for the intervention group and 3.07 for the control group spouses (p<.05).
Effects of the FOCUS Intervention on Coping Resources for Spouse/Partner
- Self-efficacy was significantly higher for spouses in the intervention group than for those in the control group at two of the three follow-up points. Mean scores for intervention and control group spouses were 144.1 and 138.8, respectively, at 4-month follow-up (p<.05) and 143.8 and 137.8 at 12-month follow-up (p<.05). At 12-month follow-up, active coping became significantly higher for intervention group spouses, with a mean of 30.5 compared to 28.9 among control group spouses (p<.05).
Effects of the FOCUS Intervention on Symptom Distress for Spouse/Partner
- Compared to control group spouses, intervention group spouses reported fewer problems related to their husbands' urinary symptoms as well as less symptom distress of their own (e.g., fewer fatigue and sleep problems). Mean scores for urinary symptom problems for intervention and control group spouses were 1.6 and 1.85, respectively, at 4-month follow-up (p<.05) and 1.53 and 1.81 at 8-month follow-up (p<.01). Mean scores for symptom distress for intervention and control group spouses at 4-month follow-up were 5.10 and 6.28, respectively (p<.01).
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