Breast Cancer Clinical Trial
— IPSICOfficial title:
An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
NCT number | NCT01881022 |
Other study ID # | CBCF-092013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | September 2017 |
Verified date | February 2019 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 80 Years |
Eligibility |
Inclusion Criteria: -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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnbrook Odette Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Canadian Breast Cancer Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Program Expectancy Questionnaire | The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective. | Pre-treatment (0 weeks) | |
Primary | 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. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up | |
Secondary | Revised Dyadic Adjustment Scale (RDAS) | The RDAS assesses couple's level of relationship satisfaction. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up | |
Secondary | Maudsley Marital Questionnaire (marital sub-scale only) | The Maudsley Marital Questionnaire assesses martial quality and happiness. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up | |
Secondary | Profile of Mood States Short Form (POMS-SF) | The POMS-SF assesses overall psychological adjustment. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up | |
Secondary | Centre for Epidemiological Studies Depression Scale | This measure assesses psychological adjustment, specifically with respect to depressive symptoms. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up | |
Secondary | Generalized Anxiety Disorder Assessment (GAD-7) | This measure assesses psychological adjustment, specifically with respect to anxiety | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up | |
Secondary | Breast Cancer Prevention Trial Symptom Checklist | The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments. | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up | |
Secondary | Spousal Skills Checklist | The SSC measures partners' perceived support of their female partners | pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up |
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