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.doi: 10.1002/pon.3036
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.
A longitudinal, repeated measures randomized controlled trial design was used.
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.
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.