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Intervention Group for Colorectal Cancer

N/A
Waitlist Available
Led By Karen Fergus, PhD, C.Psych
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this questionnaire will be completed by participants at t0 (baseline), t1 (within 1-week after intervention), t2 (1-month after intervention), and t3 (3-months after intervention)
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Colorectal Cancer
  • Sexual Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this questionnaire will be completed by participants at t0 (baseline), t1 (within 1-week after intervention), t2 (1-month after intervention), and t3 (3-months after intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and this questionnaire will be completed by participants at t0 (baseline), t1 (within 1-week after intervention), t2 (1-month after intervention), and t3 (3-months after intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in communication about sex from four different time points
Change in mutual identity from four different time points
Change in perceived self efficacy in coping with sexual and intimate changes from four different time points
+2 more
Secondary outcome measures
Change in psychological adjustment (anxiety) from four different time points
Change in psychological adjustment (depression) from four different time points
Change in relational adjustment from four different time points
+2 more
Other outcome measures
Expectancy for Change
Therapeutic Alliance

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment
Group II: Educational Comparison GroupActive Control1 Intervention
Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,550,562 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,638 Total Patients Enrolled
York UniversityOTHER
58 Previous Clinical Trials
17,416 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
2018. "An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03526952.
~9 spots leftby Apr 2025
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