Breast Cancer Clinical Trial
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.
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.
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