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

NCT ID: NCT01716702

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-09
• Study Completion Date: 2016-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Couples Prostate Cancer Support Group

Intervention Type: 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).

Wait-List Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah L McLeod, R.N., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Capital District Health Authority & Dalhousie University

Richard J Wassersug, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Karen Fergus, Ph.D., C. Psych.

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Odette Cancer Centre & York University

John Robinson, Ph.D., C. Psych.

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Centre & University of Calgary

John Oliffe, R.N, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Capital District

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA-RS/2013-076

Identifier Type: -

Identifier Source: org_study_id