A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners

Abstract

Background: Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design.

Methods: Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 30% of eligible couples consent, ≥ 70% of enrolled couples are retained, and ≥ 50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial.

Discussion: This trial will provide important information regarding the feasibility of a behavioral intervention in a vulnerable yet understudied population using videoconferencing and descriptive data regarding spiritual well-being and other indices of QOL in both mNSCLC patients and their partners.

Trial registration: ClinicalTrials.gov NCT02596490.

Keywords: Couples; Feasibility; Metastatic non-small cell lung cancer; Mind-body intervention; Quality of life; Randomized control trial; Study protocol.

Conflict of interest statement

Ethics approval of this protocol was granted by the MD Anderson Institutional Review Board. The trial will be conducted in compliance with the Declaration of Helsinki. Informed written consent will be obtained from all participants. The research team has received approval from the sponsors (National Institutes of Health/National Cancer Institute and American Cancer Society) to amend the original protocol regarding delivery of the CBMB intervention. The original protocol intervention all CBMB and AC sessions were delivered face-to-face. The protocol was amended prior to enrollment of any participants.Not applicableThe authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.