A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Canada: Beatrice Hunter Cancer Research Institute
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01716702
First received: October 16, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.

Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.

What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.

Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.


Condition Intervention
Prostate Cancer
Behavioral: Couples Prostate Cancer Support Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Change in Sexual Function from Baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in Profile of Mood States Short Form from baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]
    This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.


Estimated Enrollment: 48
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Couples Prostate Cancer Support Group

The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

Behavioral: Couples Prostate Cancer Support Group

The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

No Intervention: Wait-List Control
Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men who have been treated for localized prostate cancer
  • AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
  • Must have a heterosexual, co-cohabiting partner who is willing to participate
  • Must speak and read English
  • Must be able to use a computer and have internet access

Exclusion Criteria:

  • Homosexual couples will not be included in this study
  • Major self-reported psychiatric illness
  • Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716702

Contacts
Contact: Deborah L McLeod, R.N., Ph.D. 902-473-2964 DeborahL.McLeod@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Capital District Recruiting
Halifax, Nova Scotia, Canada
Contact: Deborah L McLeod    902-473-2964    DeborahL.McLeod@cdha.nshealth.ca   
Principal Investigator: Deborah L McLeod, R.N., Ph.D.         
Sponsors and Collaborators
Capital District Health Authority, Canada
Canada: Beatrice Hunter Cancer Research Institute
Investigators
Principal Investigator: Deborah L McLeod, R.N., Ph.D. Capital District Health Authority & Dalhousie University
Principal Investigator: Richard J Wassersug, Ph.D. University of British Columbia
Principal Investigator: Karen Fergus, Ph.D., C. Psych. Sunnybrook Odette Cancer Centre & York University
Principal Investigator: John Robinson, Ph.D., C. Psych. Tom Baker Cancer Centre & University of Calgary
Principal Investigator: John Oliffe, R.N, Ph.D. University of British Columbia
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01716702     History of Changes
Other Study ID Numbers: CDHA-RS/2013-076
Study First Received: October 16, 2012
Last Updated: March 13, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
Prostate Cancer
Psychosocial Intervention
Sexual Rehabilitation
Online Intervention

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 01, 2014