Colorectal CancerNCT03526952
An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
A study testing Internet-Delivered Intervention for Sexual Re-Adjustment and Written Educational Material in people with Colorectal Cancer and Sexual Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Sexual Dysfunction
- What is being tested?
- Internet-Delivered Intervention for Sexual Re-Adjustment and Written Educational Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Karen Fergus, PhD, 416-480-6100 ext. 81447, karen.fergus@sunnybrook.ca
Molly McCarthy, MA, 416-480-6100 ext. 81447, molly.mccarthy@sunnybrook.ca
About this study
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.
- Conditions
- Colorectal Cancer, Sexual Dysfunction
- Being tested
- Internet-Delivered Intervention for Sexual Re-Adjustment, Written Educational Material
- Medical subject headings
- Colorectal Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Delivered Intervention for Sexual Re-AdjustmentOther
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.
Written Educational MaterialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Couples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment Receives: Other: Internet-Delivered Intervention for Sexual Re-Adjustment |
| Educational Comparison Group | Active comparator | Couples in this group will receive only written educational material about sexuality and intimacy with an ostomy. Receives: Other: Written Educational Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 (5)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start4 May 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), York University
- Responsible party
- Sponsor
- Investigators
- Karen Fergus, PhD, C.Psych, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526952
- Sponsor's protocol ID
- 352-2016
- Status last verified
- Mar 2019
- First submitted
- 10 Apr 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will be shared via publication(s) in an academic journal and/or conference presentation(s)
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet Delivered Intervention for Re-Adjustment to Sexual Intimacy With an Ostomy After Cancer
- ClinicalTrials.gov ID
- NCT03526952
- Acronym / sponsor ID
- 352-2016
- Conditions
- Colorectal Cancer, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), York University
- Study start
- 4 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Internet-Delivered Intervention for Sexual Re-AdjustmentCouples in this group will receive the Internet-Delivered Intervention for Sexual Re-Adjustment |
| Educational Comparison Group | Active comparator | Other: Written Educational MaterialCouples in this group will receive only written educational material about sexuality and intimacy with an ostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Delivered Intervention for Sexual Re-AdjustmentCouples 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. | Other | Intervention Group |
| Written Educational MaterialCouples 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. | Other | Educational Comparison Group |
Primary outcome
Change in sexual functioning from four different time points
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)
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
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)
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
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)
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
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)
"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
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)
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.
5 secondary outcomes
Change in relational adjustment from four different time points
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)
Change in psychological adjustment (depression) from four different time points
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)
Change in psychological adjustment (anxiety) from four different time points
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)
Patients' change in adjustment to colorectal cancer from four different time points
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)
Patients' change in adjustment to bladder cancer from four different time points
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided. The study will be shared via publication(s) in an academic journal and/or conference presentation(s)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Fergus, PhD, C.Psych principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Delivered Intervention for Sexual Re-Adjustment and Written Educational Material in people with Colorectal Cancer and Sexual Dysfunction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Molly McCarthy, M.A. (416-480-6100 ext. 81447, molly.mccarthy@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual functioning from four different time points (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.