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

S

Sunnybrook Health Sciences Centre

Status

Unknown

Conditions

Sexual Dysfunction
Colorectal Cancer

Treatments

Other: Internet-Delivered Intervention for Sexual Re-Adjustment
Other: Written Educational Material

Study type

Interventional

Funder types

Other

Identifiers

NCT03526952
352-2016

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment
Treatment:
Other: Internet-Delivered Intervention for Sexual Re-Adjustment
Educational Comparison Group
Active Comparator group
Description:
Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.
Treatment:
Other: Written Educational Material

Trial contacts and locations

1

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Central trial contact

Molly McCarthy, M.A.

Data sourced from clinicaltrials.gov

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