Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00503646
First received: July 17, 2007
Last updated: September 16, 2013
Last verified: July 2009

July 17, 2007
September 16, 2013
May 2007
May 2010   (final data collection date for primary outcome measure)
  • Feasibility and acceptability [ Designated as safety issue: No ]
  • Descriptive characteristics of study measures [ Designated as safety issue: No ]
  • Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy [ Designated as safety issue: No ]
  • Feasibility and acceptability
  • Descriptive characteristics of study measures
  • Impact of communication intervention on couples' psychological adaptation, relationship closeness, and sexual intimacy
Complete list of historical versions of study NCT00503646 on ClinicalTrials.gov Archive Site
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Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
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.

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.

Interventional
Not Provided
Allocation: Randomized
  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sexual Dysfunction and Infertility
  • Sexuality and Reproductive Issues
  • Other: communication intervention
  • Other: counseling intervention
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
Not Provided
Manne S, Badr H, Zaider T, Nelson C, Kissane D. Cancer-related communication, relationship intimacy, and psychological distress among couples coping with localized prostate cancer. J Cancer Surviv. 2010 Mar;4(1):74-85. Epub 2009 Dec 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
United States
 
NCT00503646
07-069, MSKCC-07069
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: David W. Kissane, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Christian J. Nelson, PhD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP