This trial evaluates the helpfulness of a Couple Communication Skills Training intervention in patients with cancer and their spouses/intimate partners. Couples’ ability to communicate openly and effectively with each other about cancer-related concerns can improve their psychological adjustment and the quality of their relationship. This trial aims to see whether couple-based programs are helpful for couples in which one partner has cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04590885.
PRIMARY OBJECTIVE:
I. To evaluate whether the Couple Communication Skills Training (CCST) intervention will lead to a significantly greater increase in patient and partner relationship adjustment from pre-treatment to post-treatment and 3- month follow-ups compared to the Healthy Lifestyle Information (HLI) condition.
SECONDARY OBJECTIVES:
I. To evaluate whether the CCST intervention will lead to significantly greater improvements in (a) patient and partner individual psychological adjustment, and (b) patient health and health care outcomes from pre-treatment to post-treatment and at 3- month follow-up, compared to the HLI condition. .
II. To evaluate whether improvements in couple communication mediate the beneficial effects on the CCST intervention on patient and partner outcomes.
EXPLORATORY OBJECTIVES:
I. To explore whether role (patient vs. partner), sex, or cancer diagnosis moderate the effects of the CCST intervention.
II. To conduct an implementation-related process evaluation of the CCST intervention with the goal of expediting translation of the intervention into clinical practice.
OUTLINE: Patient-partner dyads are randomized to 1 of 2 arms.
ARM 1: Couples receive CCST intervention in six, 60-minute sessions conducted by a therapist via videoconference.
ARM 2: Couples receive Healthy Lifestyle Information (HLI) intervention in six, 60-minute sessions conducted by a therapist via videoconference.
After completion of study treatment, couples are followed up with shortly after the final session and then three months after the final session.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorLaura Porter