Clinical trial NCT03526952: An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
Official title: An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Sexual Dysfunction
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: York University
First posted: 2018-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in sexual functioning from four different time points
timeFrame: 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)
measure: Change in communication about sex from four different time points
timeFrame: 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)
measure: Change in perceived self efficacy in coping with sexual and intimate changes from four different time points
timeFrame: 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)
measure: Change in relational identity or closeness from four different time points
timeFrame: 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)
measure: Change in mutual identity from four different time points
timeFrame: 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)
Secondary outcomes:
measure: Change in relational adjustment from four different time points
timeFrame: 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)
measure: Change in psychological adjustment (depression) from four different time points
timeFrame: 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)
measure: Change in psychological adjustment (anxiety) from four different time points
timeFrame: 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)
measure: Patients' change in adjustment to colorectal cancer from four different time points
timeFrame: This questionnaire will be completed by patients diagnosed with colorectal cancer at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)
measure: Patients' change in adjustment to bladder cancer from four different time points
timeFrame: This questionnaire will be completed by patients diagnosed with bladder cancer at T0 (baseline), T1 (within 1-week after intervention), T2 (1-month after intervention), and T3 (3-months after intervention)
Other outcomes:
measure: Expectancy for Change
timeFrame: This questionnaire will be completed once at T0 (baseline)
measure: Therapeutic Alliance
timeFrame: This questionnaire will be completed once at T1 (within 1-week after intervention)
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Karen Fergus, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References: