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

NCT01881022 | Completed

• 1 other identifier: CBCF-092013
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Couples; Sexual Dysfunction; Psychosexual Intervention; Sex Therapy; Online Support; e-health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Revised Dyadic Adjustment Scale (RDAS)

  pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up

• Maudsley Marital Questionnaire (marital sub-scale only)

  pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up

• Profile of Mood States Short Form (POMS-SF)

  pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up

• Centre for Epidemiological Studies Depression Scale

  pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up

• Generalized Anxiety Disorder Assessment (GAD-7)

  pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up

Other Outcomes (1)

• Program Expectancy Questionnaire

  Pre-treatment (0 weeks)

Study Arms (1)

Psychosexual Intervention

EXPERIMENTAL

The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.

Behavioral: Psychosexual Intervention

Interventions

Psychosexual Intervention BEHAVIORAL

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.

Psychosexual Intervention

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

Sunnbrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Karen Fergus, PhD

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

CA (1)