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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Couples Prostate Cancer Support Group
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Psychosocial Intervention, Sexual Rehabilitation, Online Intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Capital DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Couples Prostate Cancer Support Group

Wait-List Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change in Sexual Function from Baseline to 13 weeks

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2012
Last Updated
March 13, 2014
Sponsor
Nova Scotia Health Authority
Collaborators
Canada: Beatrice Hunter Cancer Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01716702
Brief Title
A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
Official Title
A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Canada: Beatrice Hunter Cancer Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Psychosocial Intervention, Sexual Rehabilitation, Online Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Couples Prostate Cancer Support Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.
Intervention Type
Behavioral
Intervention Name(s)
Couples Prostate Cancer Support Group
Intervention Description
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).
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Other Pre-specified Outcome Measures:
Title
Change in Profile of Mood States Short Form from baseline to 13 weeks
Description
This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
Time Frame
Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah L McLeod, R.N., Ph.D.
Phone
902-473-2964
Email
DeborahL.McLeod@cdha.nshealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L McLeod, R.N., Ph.D.
Organizational Affiliation
Capital District Health Authority & Dalhousie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard J Wassersug, Ph.D.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Fergus, Ph.D., C. Psych.
Organizational Affiliation
Sunnybrook Odette Cancer Centre & York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Robinson, Ph.D., C. Psych.
Organizational Affiliation
Tom Baker Cancer Centre & University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Oliffe, R.N, Ph.D.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital District
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah L McLeod
Phone
902-473-2964
Email
DeborahL.McLeod@cdha.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Deborah L McLeod, R.N., Ph.D.

12. IPD Sharing Statement

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

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