Multimodal psychosocial intervention for family caregivers of patients undergoing hematopoietic stem cell transplantation: A randomized clinical trial

Abstract

Background Caregivers of patients undergoing hematopoietic stem cell transplantation (HCT) experience an immense caregiving burden before, during, and after HCT. Methods We conducted an unblinded, randomized trial of a psychosocial intervention (BMT‐CARE) for caregivers of patients undergoing autologous and allogeneic HCT at Massachusetts General Hospital. Caregivers were randomly assigned to BMT‐CARE or usual care. BMT‐CARE was tailored to the HCT trajectory and integrated treatment‐related education and self‐care with cognitive‐behavioral skills to promote coping. Caregivers assigned to BMT‐CARE met with a trained interventionist (a psychologist or a social worker) in person, via telephone, or via videoconferencing for 6 sessions starting before HCT and continuing up to day +60 after HCT. The primary endpoint was feasibility, which was defined as at least 60% of eligible caregivers enrolling and completing 50% or more of the intervention sessions. We assesed caregiver quality of life (QOL; Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), psychological distress (Hospital Anxiety and Depression Scale), self‐efficacy (Cancer Self‐Efficacy Scale–Transplant), and coping (Measures of Current Status) at baseline and 30 and 60 days after HCT. We used mixed linear effect models to assess the effect of BMT‐CARE on outcomes longitudinally. Results We enrolled 72.5% of eligible caregivers (100 of 138), and 80% attended 50% or more of the intervention sessions. Caregivers randomized to BMT‐CARE reported improved QOL (B = 6.11; 95% CI, 3.50‐8.71; P < .001), reduced caregiving burden (B = –6.02; 95% CI, –8.49 to –3.55; P < .001), lower anxiety (B = –2.18; 95% CI, –3.07 to –1.28; P < .001) and depression symptoms (B = –1.23; 95% CI, –1.92 to –0.54; P < .001), and improved self‐efficacy (B = 7.22; 95% CI, 2.40‐12.03; P = .003) and coping skills (B = 4.83; 95% CI, 3.04‐6.94; P < .001) in comparison with the usual‐care group. Conclusions A brief multimodal psychosocial intervention tailored for caregivers of HCT recipients is feasible and may improve QOL, mood, coping, and self‐efficacy while reducing the caregiving burden during the acute HCT period.

Enhanced coping and self‐efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention

“…Although the current study is an exploratory analysis, the overall study sample size (n = 100) was based on the feasibility of obtaining preliminary data to determine effect sizes for caregiver outcomes and to inform sample sizes for a future multisite study. 6 For exploring preliminary intervention effects, prior studies have suggested that at least 30 participants are needed in each group to estimate a parameter with a power analysis. 14,15…”

“…The full trial and intervention procedures have been reported previously. 6 Briefly, caregivers assigned to BMT-CARE participated in a 6-session coping skills intervention that integrated HCT-related medical information with cognitive-behavioral strategies to enhance caregiver knowledge and skills across the transplant trajectory. Sessions took place approximately weekly for 4 weeks and then every other week for the remaining 2 sessions, with the first session occurring Cancer December 15, 2020 before HCT and the last occurring up to day +60 after HCT.…”

“…Sessions were a median of 55 minutes long (range, 25-80 minutes). 6 Among those assigned to the BMT-CARE intervention, 30 caregivers (67%) attended all 6 sessions, 6 (13%) attended 3 to 5 sessions, and 2 (4.4%) attended 1 to 2 sessions. Therapists rated caregivers' home practice as mostly complete on average (median, 5; range, 1-7).…”

“…Cancer December 15, 2020 Our group recently reported findings from a single-center randomized controlled trial evaluating the feasibility and preliminary efficacy of a brief multimodal psychosocial intervention (BMT-CARE) for caregivers of patients receiving HCT. 6 BMT-CARE was informed by Van Houtven's organizational framework for caregiving interventions, 7 which outlines that a caregiver intervention may influence caregiver psychological and QOL outcomes via pathways of acquired caregiving skills in the clinical, management-related, or psychological realms. We found that BMT-CARE was feasible, and caregivers assigned to BMT-CARE reported better mood, QOL, self-efficacy, and coping skills as well as a reduced caregiving burden in comparison with the usual-care control group.…”

Understanding the Impact of Patients’ Disease Types on Caregiving Time and Caregiver Burden: An Analysis of the Health Information National Trends Survey

“…Based on ndings of this study, researchers could also consider tailoring interventions based on patients and caregivers' needs and preferences [66][67][68][69]. Findings suggest though tailored and generic interventions both have potential to decrease caregivers' anxiety and depression symptoms, tailored interventions are more likely to induce sustained long-term health improvements in caregivers [66].…”