An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer

Breast Cancer Clinical Trial

— IPSIC  

Official title:

An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881022
• Other study ID #: CBCF-092013
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: February 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Psychosexual Intervention
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.

Locations

Country	Name	City	State
Canada	Sunnbrook Odette Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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