Back to resultsAn Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
Primary Purpose
Colorectal Cancer, Sexual Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Internet-Delivered Intervention for Sexual Re-Adjustment
Written Educational Material
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer
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
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Educational Comparison Group
Arm Description
Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment
Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.
Outcomes
Primary Outcome Measures
Change in sexual functioning from four different time points
Sexual Functioning Questionnaire (SFQ): A measure sexual functioning developed specifically for cancer patients and their partners. This measure includes 22 scored items and nine subscales related to different areas of concern (i.e., Interest, Desire, Arousal, Satisfaction, Activity, Orgasm, Masturbation, Relationship, and Problems). For these subscales, higher scores represent better functioning. The optional 5-item Health Impact Scale assess the impact of cancer on the patient's sexual functioning and can be adapted for the partner. For the Health Impact subscale, higher scores represent greater impact.
Change in communication about sex from four different time points
Dyadic Sexual Communication Scale (DSC): The DSC scale is a 13-item scale that measures how respondents perceive the discussion of sexual matters with their partners. Items are rated on a 6-point Likert type scale (1 = Disagree Strongly, 6 = Agree Strongly).
Change in perceived self efficacy in coping with sexual and intimate changes from four different time points
Sexual Self-Efficacy: A 3-item questionnaire for assessing individual's perceived self-efficacy in coping with sexual and intimate change in the context of cancer. Respondents rate their level of confidence in coping with these changes on a scale of 0-100 (0 = cannot do at all, 100 = highly certain can do).
Change in relational identity or closeness from four different time points
"We-ness" Questionnaire: A measure of the degree partner's perceive themselves more as being a unit ("we/us") than two separate identities ("I/me" or "you/him/her"), which encompassed an intertwined structure of affective, cognitive, and behavioural facets. The questionnaire includes 16-items about facets of couples' mutual identity and respondents use a 5-point Likert scale to rate the degree to which these facets contribute to their sense of mutual identity in their current relationship. Higher scores represent a greater sense of shared identity.
Change in mutual identity from four different time points
Inclusion of Other In Self Scale (IOSS): The IOSS is a one-item, visual measure of the degree to which one views one's partner as being part of one's self-concept. Respondents choose one of seven Venn-diagram type images that represent varying degrees of mutual identity. Higher scores represent greater degrees of self-other overlap in identity.
Secondary Outcome Measures
Change in relational adjustment from four different time points
Revised Dyadic Adjustment Scale: A 14-item self-report questionnaire measuring respondents' relational adjustment in terms of consensus, satisfaction, and cohesion. Items are scaled on a 6-point Likert scale.
Change in psychological adjustment (depression) from four different time points
Centre for Epidemiological Studies Depression Scale- Revised (CESD-R): A brief 20-item self-report measure of depressive symptoms experienced over the past week. Respondents indicate how often they have experienced the symptoms over the past week using a 5-point Likert scale. Higher scores indicate higher risk for clinical depression.
Change in psychological adjustment (anxiety) from four different time points
Generalized Anxiety Disorder-7 (GAD-7): A brief, 7-item, self-report measure of generalized anxiety. Respondents indicate how often they have experienced symptoms of generalized anxiety over the past two weeks, using a 4-point Likert scale. Higher scores indicate greater levels of difficulty.
Patients' change in adjustment to colorectal cancer from four different time points
Functional Assessment for Cancer Treatment - Colorectal Cancer (FACT-C): The "Colorectal Cancer" subscale of the FACT-C will be completed by patients only as a measure of their adjustment to the colorectal cancer and ostomy. The subscale includes 9-items about physical and psychological symptoms related to colorectal cancer and respondents are to indicate the degree to which they experienced these symptoms in the past week using a 5-point Likert scale (0 = not at all, 5 = very much).
Patients' change in adjustment to bladder cancer from four different time points
Functional Assessment for Cancer Treatment - Bladder Cancer (FACT-Bl): The "Bladder Cancer" subscale of the FACT-Bl will be completed by patients only as a measure of their adjustment to the colorectal cancer and ostomy. The subscale includes 9-items about physical and psychological symptoms related to bladder cancer and respondents are to indicate the degree to which they experienced these symptoms in the past week using a 5-point Likert scale (0 = not at all, 5 = very much).
Full Information
NCT ID
NCT03526952
First Posted
April 10, 2018
Last Updated
March 8, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), York University
1. Study Identification
Unique Protocol Identification Number
NCT03526952
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Sexual Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment
Arm Title
Educational Comparison Group
Arm Type
Active Comparator
Arm Description
Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy.
Intervention Type
Other
Intervention Name(s)
Internet-Delivered Intervention for Sexual Re-Adjustment
Intervention Description
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
Intervention Name(s)
Written Educational Material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sexual functioning from four different time points
Description
Sexual Functioning Questionnaire (SFQ): A measure sexual functioning developed specifically for cancer patients and their partners. This measure includes 22 scored items and nine subscales related to different areas of concern (i.e., Interest, Desire, Arousal, Satisfaction, Activity, Orgasm, Masturbation, Relationship, and Problems). For these subscales, higher scores represent better functioning. The optional 5-item Health Impact Scale assess the impact of cancer on the patient's sexual functioning and can be adapted for the partner. For the Health Impact subscale, higher scores represent greater impact.
Time Frame
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)
Title
Change in communication about sex from four different time points
Description
Dyadic Sexual Communication Scale (DSC): The DSC scale is a 13-item scale that measures how respondents perceive the discussion of sexual matters with their partners. Items are rated on a 6-point Likert type scale (1 = Disagree Strongly, 6 = Agree Strongly).
Time Frame
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)
Title
Change in perceived self efficacy in coping with sexual and intimate changes from four different time points
Description
Sexual Self-Efficacy: A 3-item questionnaire for assessing individual's perceived self-efficacy in coping with sexual and intimate change in the context of cancer. Respondents rate their level of confidence in coping with these changes on a scale of 0-100 (0 = cannot do at all, 100 = highly certain can do).
Time Frame
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)
Title
Change in relational identity or closeness from four different time points
Description
"We-ness" Questionnaire: A measure of the degree partner's perceive themselves more as being a unit ("we/us") than two separate identities ("I/me" or "you/him/her"), which encompassed an intertwined structure of affective, cognitive, and behavioural facets. The questionnaire includes 16-items about facets of couples' mutual identity and respondents use a 5-point Likert scale to rate the degree to which these facets contribute to their sense of mutual identity in their current relationship. Higher scores represent a greater sense of shared identity.
Time Frame
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)
Title
Change in mutual identity from four different time points
Description
Inclusion of Other In Self Scale (IOSS): The IOSS is a one-item, visual measure of the degree to which one views one's partner as being part of one's self-concept. Respondents choose one of seven Venn-diagram type images that represent varying degrees of mutual identity. Higher scores represent greater degrees of self-other overlap in identity.
Time Frame
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 Outcome Measure Information:
Title
Change in relational adjustment from four different time points
Description
Revised Dyadic Adjustment Scale: A 14-item self-report questionnaire measuring respondents' relational adjustment in terms of consensus, satisfaction, and cohesion. Items are scaled on a 6-point Likert scale.
Time Frame
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)
Title
Change in psychological adjustment (depression) from four different time points
Description
Centre for Epidemiological Studies Depression Scale- Revised (CESD-R): A brief 20-item self-report measure of depressive symptoms experienced over the past week. Respondents indicate how often they have experienced the symptoms over the past week using a 5-point Likert scale. Higher scores indicate higher risk for clinical depression.
Time Frame
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)
Title
Change in psychological adjustment (anxiety) from four different time points
Description
Generalized Anxiety Disorder-7 (GAD-7): A brief, 7-item, self-report measure of generalized anxiety. Respondents indicate how often they have experienced symptoms of generalized anxiety over the past two weeks, using a 4-point Likert scale. Higher scores indicate greater levels of difficulty.
Time Frame
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)
Title
Patients' change in adjustment to colorectal cancer from four different time points
Description
Functional Assessment for Cancer Treatment - Colorectal Cancer (FACT-C): The "Colorectal Cancer" subscale of the FACT-C will be completed by patients only as a measure of their adjustment to the colorectal cancer and ostomy. The subscale includes 9-items about physical and psychological symptoms related to colorectal cancer and respondents are to indicate the degree to which they experienced these symptoms in the past week using a 5-point Likert scale (0 = not at all, 5 = very much).
Time Frame
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)
Title
Patients' change in adjustment to bladder cancer from four different time points
Description
Functional Assessment for Cancer Treatment - Bladder Cancer (FACT-Bl): The "Bladder Cancer" subscale of the FACT-Bl will be completed by patients only as a measure of their adjustment to the colorectal cancer and ostomy. The subscale includes 9-items about physical and psychological symptoms related to bladder cancer and respondents are to indicate the degree to which they experienced these symptoms in the past week using a 5-point Likert scale (0 = not at all, 5 = very much).
Time Frame
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 Pre-specified Outcome Measures:
Title
Expectancy for Change
Description
Credibility/expectancy questionnaire: A brief 6-item measure of treatment expectancy and rationale credibility.
Time Frame
This questionnaire will be completed once at T0 (baseline)
Title
Therapeutic Alliance
Description
Working Alliance Inventory Short Form-Revised (WAI-SR): The WAI-SR will be used to measure each participant's working alliance with the therapist facilitating the two session intervention. The WAI-SR is a 12-item self-report measure of working alliance from the client's perspective that uses a 5-point Likert scale, where higher score represent better working alliance between client and therapist.
Time Frame
This questionnaire will be completed once at T1 (within 1-week after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly McCarthy, M.A.
Phone
416-480-6100
Ext
81447
Email
molly.mccarthy@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fergus, PhD, C.Psych
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Fergus, PhD
Phone
416-480-6100
Ext
81447
Email
karen.fergus@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Molly McCarthy, MA
Phone
416-480-6100
Ext
81447
Email
molly.mccarthy@sunnybrook.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study will be shared via publication(s) in an academic journal and/or conference presentation(s)
Learn more about this trial
An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
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