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

NCT01716702 | Completed DMC

• 1 other identifier: CDHA-RS/2013-076
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Psychosocial Intervention; Sexual Rehabilitation; Online Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Sexual Function from Baseline to 13 weeks

  Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Secondary Outcomes (1)

• Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks

  Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Other Outcomes (1)

• Change in Profile of Mood States Short Form from baseline to 13 weeks

  Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Study Arms (2)

Couples Prostate Cancer Support Group

EXPERIMENTAL

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

Wait-List Control

NO INTERVENTION

Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.

Interventions

Couples Prostate Cancer Support Group BEHAVIORAL

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).

Couples Prostate Cancer Support Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital District

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 30, 2012
• Study Start: July 9, 2012
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: August 21, 2024

Record last verified: 2014-03

Locations

CA (1)