Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial.

Abstract

To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients' symptoms. In this SMART, patient-caregiver dyads were initially randomized to 4weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models. In the comparison of 4 adaptive intervention sequences: reflexology for 8weeks, reflexology for 4weeks followed by MP for 4weeks if no response to reflexology, MP for 8weeks, and MP for 4weeks followed by reflexology for 4weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one. Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains. ClinicalTrials.gov Identifier: NCT02759146.