Objective: To determine through a randomized controlled trial how, after adjusting for caregiver depression at intake, a 10 contact, 20 week nursing intervention compared with conventional care affects the level of caregiver involvement in the management of patients’ symptoms reported at 20 weeks? This research addresses an important question: Are depressed caregivers less likely to respond to interventions designed to assist them in managing symptoms of their patients with cancer who are undergoing a new course of chemotherapy than non-depressed caregivers?
Design: A randomized clinical trial was implemented in oncology treatment settings.
Population: Patients with a new diagnosis of a solid tumor and undergoing a first course of chemotherapy, who had a family caregiver, with both able to speak and read English, and without hearing deficits that limited telephone conversation were eligible for enrollment.
Sample: Recruiters approached all consecutive patients meeting criteria, explained the study, provided a brochure summarizing their roles. Patients and family caregivers who consented were interviewed at baseline and randomized to the experimental or control group. One hundred seventeen (117) caregivers were in the experimental and 118 in the control group. At entry approximately 30% of the caregivers in each group reported CESD scores at 16 or higher with females reported slightly higher depression scores than males. Forty five percent (45%) of caregivers were male, 55% female. Sixty percent (60%) were spouses with the remainder adult children; 60% had some college education and 60% in each group were employed.
Variables: Caregiver measures were obtained at baseline 10, 20 and 32 weeks. The CESD (reliability above .89 on all observations) was used to measure depression. Involvement in symptom management was assessed by asking caregivers if their patient experienced any of the 12 symptoms (Yes/No); if yes, did they assist with the management of that symptom (Yes/No). Responses were recorded on a yes/no response scale. Caregivers’ ratings of limitation and bother for each symptom, and confidence in management were rated on a 5-point scales. Proportions and summary scales scores were created and adjusted by numbers of symptoms identified.
Methods: All patients and caregivers were interviewed at baseline, 10, 20 and 32 weeks. Patients and caregivers in the experimental arm received the 10 contact, 20-week intervention. The first intervention was in person with both the patient and their caregiver. Subsequent interventions alternated between in person and telephone contacts. The 10 week interview was conducted after the 4th intervention, the 20 week immediately following the end of the intervention and the 32 week interview 12 weeks later. To address the research questions multi-variate measures adjusting for baseline covariates were used.
Experimental Intervention: Nurse interveners assessed each patient and caregiver at each contact. Assessments focused on 12 symptoms, caregiver role strain and caregiver health. All patient severity of symptoms, and impact upon limitations that reached threshold were transferred to the caregiver plan of care. The nurse and the caregiver determined which problems to address. Intervention strategies were drawn from an evidence-based list around symptom management, communication, support, teaching/information. Caregivers were assigned tasks by the nurse intervener to assist their patients with symptoms, function and to alleviate emotional distress. Each problem was evaluated at subsequent contacts and interventions continued, changed or deleted as appropriate. Problems caregivers encountered such as tasks of caring, role strain and emotional distress were managed through strategies specific to the “caregivers” problems.
Findings: Caregivers who scored 16 or higher on the CESD at intake were not significantly different from their counterparts in the control with respect to identification of numbers of interventions. Depressed caregivers in the experimental group were more likely to be involved in symptom assistance than those in the control. Depressed caregivers in the experimental group were more confident in managing symptoms than their counterparts in the control and as numbers of symptoms reported increased depressed caregivers in the experimental group were more likely to say they were confident in managing these symptoms. Thus, depressed caregivers were assisted by the intervention compared with those in the control group. This pattern was more pronounced among depressed as opposed to non-depressed caregivers in each group.
Conclusion: Nursing interventions can positively influence caregiver outcomes. Caregiver depression needs to be considered and addressed as clinical applications directed toward improving family caregiver involvement in management of patient symptoms associated with cancer treatment.
Implications: Thus focusing on the family member may enhance the therapeutic clinical outcomes of the patient.
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