Breast CancerIPSICNCT01881022
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer
A study testing Psychosexual Intervention in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychosexual Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Sep 2017
- 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 Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -Patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
- Patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e.
- chemotherapy, radiation, tamoxifen)
- Patient is at least 1 month post-treatment.
- Couples are in a committed relationship of at least 3 months duration at the time of diagnosis
- Participants must be fluent in English
- Participants must be 80 years of age or younger
- Participants will require convenient access to a computer with a reliable internet connection in a private setting and have access to videoconferencing software (available for download at no cost).
Who cannot join
- One or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic
- Couples who plan to participate in couples or sex counselling during the study
- Couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.
Read the detailed description
Many couples experience sexual problems following breast cancer treatment, and difficulties with intimacy and sexuality tend to extend past the 1 year post-treatment point. Given that resources available for couples who experience sexual distress after breast cancer are virtually non-existent, there is a need to develop and empirically evaluate psychosexual interventions for breast cancer patients and their partners.
The purpose of this study is to evaluate the feasibility, process, and outcomes of an online, couples-based intervention designed to address sexual problems encountered by many couples facing breast cancer. The intervention will take place in the form of six E-therapy sessions delivered via secure, encrypted videoconferencing software commonly used by health care providers practicing telemedicine. Each session will be supplemented by psychoeducational materials (i.e. reading and/or video) available through a privately accessed homepage for the study.
Thirty couples will participate in the study, and will be be randomized to either the treatment condition or the wait-list control condition. Participants assigned to the wait-list will have the option of receiving the online program once they have completed their commitment to the study (approximately 5 months later). In addition to completing standardized questionnaires, couples will participate in pre- and post-treatment interviews, which will be analyzed thematically in order to improve the intervention and its delivery.
The proposed project builds upon existing research pertaining to the sexual health implications of female cancer survivorship, and will fill a gap both in the literature and support available to breast cancer survivors experiencing sexual distress. Given that sexual distress is such a crucial concern for women with breast cancer, and that the majority of couples experiencing sexual difficulties may not receive adequate support in this regard, the goal of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help improve the quality of life of couples affected by breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Psychosexual Intervention
- Keywords
- Breast Cancer, Couples, Sexual Dysfunction, Psychosexual Intervention, Sex Therapy, Online Support, e-health
- Medical subject headings
- Breast Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosexual InterventionBehavioural
Couples will complete six weekly psychosexual counselling sessions. Each session will focus on areas relevant to sex therapy and sexual dysfunction in couples facing breast cancer (e.g. education, communication, body imagery, sensate focusing, and problem solving). Sessions will be one hour in length (Note: Session 1 will be 1.5 hours), during which couples will meet with a facilitator via videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| Psychosexual Intervention | Experimental | The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing. Receives: Behavioral: Psychosexual Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Secondary outcomes (7)
Revised Dyadic Adjustment Scale (RDAS)
The RDAS assesses couple's level of relationship satisfaction.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Maudsley Marital Questionnaire (marital sub-scale only)
The Maudsley Marital Questionnaire assesses martial quality and happiness.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Profile of Mood States Short Form (POMS-SF)
The POMS-SF assesses overall psychological adjustment.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Centre for Epidemiological Studies Depression Scale
This measure assesses psychological adjustment, specifically with respect to depressive symptoms.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Generalized Anxiety Disorder Assessment (GAD-7)
This measure assesses psychological adjustment, specifically with respect to anxiety
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Breast Cancer Prevention Trial Symptom Checklist
The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Spousal Skills Checklist
The SSC measures partners' perceived support of their female partners
Measured: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Principal investigator, Karen Fergus, Sunnybrook Health Sciences Centre
- Investigators
- Karen Fergus, PhD, Principal investigator, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881022
- Sponsor's protocol ID
- CBCF-092013
- Acronym
- IPSIC
- Status last verified
- Feb 2019
- First submitted
- 14 Jun 2013
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
- ClinicalTrials.gov ID
- NCT01881022
- Acronym / sponsor ID
- IPSIC / CBCF-092013
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Couples, Sexual Dysfunction, Psychosexual Intervention, Sex Therapy, Online Support, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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.
Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.
Detailed description
Many couples experience sexual problems following breast cancer treatment, and difficulties with intimacy and sexuality tend to extend past the 1 year post-treatment point. Given that resources available for couples who experience sexual distress after breast cancer are virtually non-existent, there is a need to develop and empirically evaluate psychosexual interventions for breast cancer patients and their partners.
The purpose of this study is to evaluate the feasibility, process, and outcomes of an online, couples-based intervention designed to address sexual problems encountered by many couples facing breast cancer. The intervention will take place in the form of six E-therapy sessions delivered via secure, encrypted videoconferencing software commonly used by health care providers practicing telemedicine. Each session will be supplemented by psychoeducational materials (i.e. reading and/or video) available through a privately accessed homepage for the study.
Thirty couples will participate in the study, and will be be randomized to either the treatment condition or the wait-list control condition. Participants assigned to the wait-list will have the option of receiving the online program once they have completed their commitment to the study (approximately 5 months later). In addition to completing standardized questionnaires, couples will participate in pre- and post-treatment interviews, which will be analyzed thematically in order to improve the intervention and its delivery.
The proposed project builds upon existing research pertaining to the sexual health implications of female cancer survivorship, and will fill a gap both in the literature and support available to breast cancer survivors experiencing sexual distress. Given that sexual distress is such a crucial concern for women with breast cancer, and that the majority of couples experiencing sexual difficulties may not receive adequate support in this regard, the goal of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help improve the quality of life of couples affected by breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosexual Intervention | Experimental | Behavioral: Psychosexual InterventionThe intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- -Patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
- Patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e.
- chemotherapy, radiation, tamoxifen)
- Patient is at least 1 month post-treatment.
- Couples are in a committed relationship of at least 3 months duration at the time of diagnosis
Key exclusion criteria (3 listed)
- One or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic
- Couples who plan to participate in couples or sex counselling during the study
- Couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
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 |
|---|---|---|
| Psychosexual InterventionCouples will complete six weekly psychosexual counselling sessions. Each session will focus on areas relevant to sex therapy and sexual dysfunction in couples facing breast cancer (e.g. education, communication, body imagery, sensate focusing, and problem solving). Sessions will be one hour in length (Note: Session 1 will be 1.5 hours), during which couples will meet with a facilitator via videoconferencing. | Behavioural | Psychosexual Intervention |
Primary outcome
Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
7 secondary outcomes
Revised Dyadic Adjustment Scale (RDAS)
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Maudsley Marital Questionnaire (marital sub-scale only)
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Profile of Mood States Short Form (POMS-SF)
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Centre for Epidemiological Studies Depression Scale
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Breast Cancer Prevention Trial Symptom Checklist
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Spousal Skills Checklist
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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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 principal investigator
Toronto Sunnybrook Regional Cancer 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 Psychosexual Intervention in people with Breast Cancer, 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 25 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up (time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up). 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 25 Feb 2019.