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


N/A
18 Years
N/A
Open (Enrolling)
Both
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction and Infertility, Sexuality

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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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Outcome Measure:

Feasibility and acceptability

Safety Issue:

No

Principal Investigator

David W. Kissane, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

Unspecified

Study ID:

CDR0000557017

NCT ID:

NCT00503646

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sexual Dysfunction and Infertility
  • Sexuality
  • psychosocial effects of cancer and its treatment
  • sexual dysfunction and infertility
  • sexuality and reproductive issues
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage I prostate cancer
  • Infertility
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497