Trial Information

Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial

OBJECTIVES:

Primary

- To evaluate the feasibility and acceptability of conducting a randomized clinical trial
evaluating communication and intimacy-enhancing intervention (CI) vs usual care (UC).

- To collect descriptive information and basic psychometrics on proposed study measures.

- To gather preliminary data regarding the impact of CI on couples' psychosocial
adaptation, relationship closeness, and sexual intimacy in order to calculate power for
a larger full scale trial.

OUTLINE: This is a multicenter study. Patients and their partners are randomized to 1 of 2
intervention arms.

- Arm I: Patients and their partners receive communication and intimacy-enhancing
intervention (CI) once a week comprising the following five 90-minute sessions:
Rationale and Overview; Basic Communication; Intimacy and Sexuality; Improving
Intimacy; and Reflecting on Changes and Cancer Survivorship.

- Arm II: Patients and their partners receive standard psychological and emotional care
(usual care [UC]) (i.e., social work consultations and referral to a psychiatrist or
psychologist, if requested or deemed necessary by the attending physician).

Physical impairment, psychological adjustment, relationship closeness, relationship
communication, sexual function and satisfaction, male self-esteem, relationship
satisfaction, intervention evaluation, and erectile dysfunction treatment utilization, and
referral are assessed at 1 week post-intervention or at 6-8 weeks post baseline and then at
3 months (for patients and their partners in arm I) and at 8 weeks post-baseline and then at
3 months (for patients and their partners in arm II).

PROJECTED ACCRUAL: A total of 50 patients and 50 partners will be accrued for this study.