Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer, Cancer, Psychiatric, Women's Studies |
Therapuetic Areas: | Oncology, Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | May 2007 |
Communication and Intimacy-Enhancing Intervention for Men Diagnosed With Early Stage Prostate Cancer and Their Partners: A Pilot and Feasibility Trial
RATIONALE: Participating in a therapy program may enhance communication and intimacy between
men with prostate cancer and their partners.
PURPOSE: This randomized clinical trial is studying how well therapy enhances communication
and intimacy for men with early stage prostate cancer and for their partners.
men with prostate cancer and their partners.
PURPOSE: This randomized clinical trial is studying how well therapy enhances communication
and intimacy for men with early stage prostate cancer and for their partners.
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.
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.
DISEASE CHARACTERISTICS:
- Patient has a primary diagnosis of localized (early stage) prostate cancer
- Has undergone surgery within the past year
- Patient and partner married or cohabiting and relationship duration ≥ 1 year
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1 at the time of initial recruitment
- Lives within 2-hour commuting distance from recruitment center (MSKCC or FCCC)
- No significant self-identified hearing impairment that would preclude study
participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
We found this trial at
2
sites
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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