Clinical trial NCT01881022: An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer
Official title: An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Couples
Sexual Dysfunction
Psychosexual Intervention
Sex Therapy
Online Support
e-health
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2013-06-19
Enrollment: 36
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Secondary outcomes:
measure: Revised Dyadic Adjustment Scale (RDAS)
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
measure: Maudsley Marital Questionnaire (marital sub-scale only)
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
measure: Profile of Mood States Short Form (POMS-SF)
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
measure: Centre for Epidemiological Studies Depression Scale
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
measure: Breast Cancer Prevention Trial Symptom Checklist
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
measure: Spousal Skills Checklist
timeFrame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Other outcomes:
measure: Program Expectancy Questionnaire
timeFrame: Pre-treatment (0 weeks)
Locations:
city: Toronto
country: Canada
facility: Sunnbrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Karen Fergus, PhD
role: PRINCIPAL_INVESTIGATOR
References: