Northouse, L.L., Mood, D.W., Schafenacker, A., Kalemkerian, G., Zalupski, M., Lorusso, P., . . . Kershaw, T. (2013). Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psycho-Oncology, 22, 555–563.

To determine (a) whether patient/caregiver dyads randomly assigned to either an extensive or brief dyadic intervention (i.e., FOCUS program) would have better intermediary outcomes (i.e., less negative appraisals and increased resources) and primary outcomes (i.e., improved quality of life) than control patient/caregiver dyads receiving usual care, and (b) whether risk for distress and other antecedent factors (e.g., gender, type of dyadic relationship, cancer type) would moderate the effect of either the brief or extensive program on intermediary and primary outcomes

A stratified randomization process placed participants into groups according to risk status, cancer type, and research site. Participants were then randomly assigned to one of three study arms: control group (usual care), brief FOCUS group, or extensive FOCUS program. The FOCUS intervention was a home-based dyadic intervention used by the authors in previous randomized controlled trial studies and focused on providing support to the patient/caregiver unit. The FOCUS program addressed five content areas: family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. The brief FOCUS program intervention consisted of three contacts (two 90-minute home visits and one 30-minute phone encounter), while the extensive FOCUS program intervention included six contacts (four 90-minute home visits and two 30-minute phone discussions). Both interventions lasted 10 weeks. Trained intervention nurses delivered the home interventions, and attention occurred throughout the study to ensure treatment fidelity (protocol checklist, length of session, randomly tape-recorded sessions). Data were collected by research nurses blinded to dyads’ group assignment at baseline and at three and six months postbaseline for the three groups in the study.    

• The sample was comprised of 484 patient/caregiver dyads.  
• Mean patient age was 60.5 years (SD = 10.9); mean caregiver age was 56.7 years (SD = 12.6).
• Males represented 38.6% of patients and 44.2% of caregivers; females represented 61.4% of patients and 55.8% of caregivers.
• At enrollment, most patients had breast cancer (32%), followed by lung (29%), colorectal (25%), or prostate (13%) cancer.
• Mean years of education for participants was 14.8 years (SD = 2.7).
• The sample was 85.5% Caucasian, and 74% of caregivers were spouses.
• Patients (72%) and caregivers (66%) had comorbid conditions, including hypertension or heart problems; patients’ average length of time since diagnosis was 47 months, and 66%  were receiving chemotherapy; no significant differences existed between the three groups (usual care, brief intervention, and extended intervention) on changes in treatment, progression of disease, demographic or medical variables, or study attrition.
• The study had 62.4% retention.

• Multisite
• Home setting
• Four cancer centers in metropolitan areas of Michigan, Nevada, and Connecticut

• Active treatment phase for advanced cancer
• Late effects and survivorship

A longitudinal, repeated measures randomized controlled trial design was used. 

• Risk for Distress Scale (RDS): To measure demographics, health history, current concerns, and symptom distress; appropriate internal consistency values were collected at three assessment times.   
• Appraisal of Illness Scale (patients) and Appraisal of Caregiving (caregivers): To assess perceptions and appraisal  of cancer experience; appropriate internal consistency values were collected at three data collection times; averaged internal consistency range was 0.89–0.91 over three assessment periods.
• Mishel’s Uncertainty in Illness Scale: To measure the degree of uncertainty experienced during an illness    
• Beck Hopelessness Scale: To measure level of  hopelessness; averaged internal consistency range was 0.84–0.88 over three assessment periods.  
• Brief Cope: To measure active and avoidant coping behaviors; averaged internal consistency range was 0.78–0.88 over three assessment periods. 
• Healthy Behaviors: To assess activities encouraged in the intervention (i.e., healthy diet, exercise); averaged internal consistency range was 0.61–0.67 over three assessment periods.
• Lewis Mutuality and Sensitivity Scale: To assess communication within dyad; averaged internal consistency range was 0.93–0.94 over three assessment periods.
• Lewis Cancer Self-Efficacy Scale: To measure the level of self-efficacy; averaged internal consistency was 0.98 over three assessment periods.
• Social Support Questionnaire: To measure the level of dyadic support; averaged internal consistency range was 0.84–0.87 over three assessment periods.
• Functional Assessment of Cancer Therapy: To assess overall quality of life and four domains: social, emotional, functional, and physical well-being; averaged internal consistency range was 0.75–0.86 over three assessment periods.

Data collection occurred over four years with 62.4% retention for all data assessment points. Significant group by time interactions occurred and showed that the dyads in the FOCUS program (brief and extensive) had significant improvement in coping (p <0.05), self-efficacy(p < 0.05), social quality of life (p < 0.01),  and  caregivers’ emotional quality of life (p < 0.05). Extensive FOCUS program (p = 0.001) and brief FOCUS program (p = 0.033) dyads had decreased avoidant coping at three months, but this only remained in the brief group at six months. Extensive FOCUS program and brief program dyads maintained social quality of life at three and six months. Only brief FOCUS group couples significantly increased their use of healthy behaviors at three months (p = 0.001), but this was not sustained at the six-month assessment. Overall effects varied by intervention dose (extensive versus brief FOCUS program), and most were found only at three months. Risk for distress supported very few moderation effects.

Both brief and extensive FOCUS interventions supported positive dyadic outcomes, but few sustained outcomes were identified at six-month assessment. This study showed a six-week intervention significantly improved dyads’ self-efficacy, but a shorter three-week intervention significantly improved their use of healthy behaviors. Level of risk for distress did not significantly affect or moderate the outcomes of the intervention.

• Only patients’ risk status (high versus low [categorical variable]) was used to stratify patients into groups, thus limiting the sample found for study; using a continuous variable or a dyadic risk score might have produced different findings.
• The study needed to collect information on patients’ functional status over time for more complete interpretation of findings.
• The study had no attentional control.

This study offered insight into a theory-based intervention for advanced and diverse diagnosis of patients with cancer and their caregivers to improve their coping ability, self-efficacy, and quality of life as individuals and as dyads. Too often caregivers are ignored in patient oncology care, yet evidence indicates that the interdependency of patient and caregiver demands nursing interventions that respond to patient and caregiver cancer challenges. With a move toward more interdisciplinary oncology care and measurement of cost-effective and quality interventions, nurses will play an important role in supporting inpatient and outpatient practice environments that implement and evaluate multifaceted interventions known to improve dyadic response to cancer.