An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-04

Study Completion Date

2019-08-31

Brief Summary

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This study investigates the feasibility and efficacy of an Internet-delivered intervention for the sexual and intimate re-adjustment of couples in which one partner is living with a temporary or permanent ostomy (e.g., colostomy, ileostomy, urostomy) following treatment for colorectal and/or bladder cancer. The two session intervention will be delivered via online videoconferencing and will focus on facilitating couples' communication around their sexual and intimate relationship. Exercises from sex therapy will be used to scaffold conversations about motivations for having sex, intimacy and sensual pleasure, and relational strengths for coping. The intervention aims to enhance couples' ability to cope with the changes in their sexual and intimate relationship. A group of couples receiving written educational material only will be used as a comparison group to measure change in sexual and intimate adjustment over time.

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Detailed Description

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Conditions

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Colorectal Cancer Sexual Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment

Group Type EXPERIMENTAL

Internet-Delivered Intervention for Sexual Re-Adjustment

Intervention Type OTHER

Couples will meet with a therapist via video-conferencing for two 1.5-hr sessions. The therapist will facilitate couples' communication about their sexual and intimate relationship while providing psychoeducation about couple coping and sexuality after cancer and with an ostomy. Discussion will focus on current concerns, motivations for sex, relational strengths, and intimacy and sensual pleasure. Couples will also be encouraged to practice a sensate focusing exercise between sessions.

Educational Comparison Group

Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.

Group Type ACTIVE_COMPARATOR

Written Educational Material

Intervention Type OTHER

Couples will receive written educational material for patients coping with changes in intimacy and sexuality when living with a permanent ostomy. This educational material is published by the United Ostomy Associations of America, Inc. and is available for free download from their website. Couples will have two weeks to read this material.

Interventions

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Internet-Delivered Intervention for Sexual Re-Adjustment

Couples will meet with a therapist via video-conferencing for two 1.5-hr sessions. The therapist will facilitate couples' communication about their sexual and intimate relationship while providing psychoeducation about couple coping and sexuality after cancer and with an ostomy. Discussion will focus on current concerns, motivations for sex, relational strengths, and intimacy and sensual pleasure. Couples will also be encouraged to practice a sensate focusing exercise between sessions.

Intervention Type OTHER

Written Educational Material

Couples will receive written educational material for patients coping with changes in intimacy and sexuality when living with a permanent ostomy. This educational material is published by the United Ostomy Associations of America, Inc. and is available for free download from their website. Couples will have two weeks to read this material.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients meeting all of the following criteria will be eligible for the study:

* Patients who have had a diagnosis of colorectal and/or bladder cancer within their lifetime
* Patients who are at least 1-month post active treatment for colorectal and/or bladder cancer
* Patients who have an ostomy due to colorectal and/or bladder cancer (e.g., colostomy, ileostomy, urostomy; permanent or temporary)
* Patients who are in a committed intimate relationship
* Patients who report changes in their sexual/intimate relationship associated with colorectal and/or bladder cancer and/or living with an ostomy
* Patients who have access to the Internet in a private space
* Patients who reside in Ontario
* Patients who are 18 years of age or older

OR

Partners of patients who meet the above criteria and who are 18 years of age or older

Exclusion Criteria

Patients/couples will be excluded from study participation if:

* Patient is undergoing active treatment for cancer
* Patient or partner report high levels of relational distress and would be better suited to couples therapy
* Couple is attending or plans to attend couples or sex therapy concurrently with participation in study
* Patient or partner is currently experiencing mental health concerns that would interfere with study participation (e.g., suicidal ideation, psychotic disorders, substance abuse, spousal abuse)
* Patient or partner lack English proficiency

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes