Trial details

Trial short name: An Internet-delivered Intervention for Re-adjustment to Sexual Intimacy with a Permanent Ostomy after Colorectal Cancer

Official title: An Internet-delivered Intervention for Re-adjustment to Sexual Intimacy with a Permanent Ostomy after Colorectal Cancer

Principal Investigator: Dr. Karen Fergus

Cancer type: Gastrointestinal
Cancer location: Colorectal
Disease stage: Early and Advanced Cancer
Trial phase: Other
Intervention: Online Intervention

Registration #: NCT03526952

Contact name: Molly McCarthy

Contact phone: 416-480-6100 ext. 81447

Trial description:
The purpose of this study is to evaluate the efficacy of a novel and brief online intervention to support couples' sexual re-adjustment when one individual is living with a permanent ostomy after treatment for colorectal cancer. Patients living with a permanent ostomy after colorectal cancer who meet certain eligibility criteria may be able to participate with their partners. There will be two groups of couples participating in this study; one group will receive the professionally facilitated intervention delivered through a secure online videoconferencing platform while the other group will receive written educational information about sex with an ostomy after colorectal cancer. Patients and partners who participate will know which group they are assigned to and those in the educational group will have the option of receiving the online intervention after they finish their participation. All participation is online, therefore travel to Sunnybrook is not required and couples from across Ontario with access to the Internet may participate.

Inclusion Criteria: • Diagnosis of colorectal cancer within their lifetime • Received medical treatment for colorectal cancer, which may or may not have included chemotherapy and/or radiation • Patients who are in a committed intimate relationship, regardless of length of relationship • Patients who have a permanent ostomy due to colorectal cancer (i.e., colostomy, ileostomy) • Over the age of 18 years • Self-report changes in their sexual/intimate relationship to the colorectal cancer and/or permanent ostomy • Access to the Internet in a private space (webcams can be provided) • Residing anywhere in Ontario (not only the GTA) Exclusion Criteria: • Living outside of Ontario • Not fluent in English (i.e. speaking, reading, and writing) • Experiencing high levels of distress in their relationship and would be better suited for formal couples therapy; the Kansas Marital Satisfaction Survey will be verbally administered to patients and partners to screen for distress and highly distressed couples will be referred to Sunnybrook Patient and Family Services • Currently experiencing mental health concerns that would interfere with study participation. (e.g., suicidality, psychotic disorders, substance abuse, spousal abuse etc.) • Attending or want to attend couples or sex therapy during their participation