Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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

Karen Fergus, PhD

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.

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

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

The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.

The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.

The RDAS assesses couple's level of relationship satisfaction.

The Maudsley Marital Questionnaire assesses martial quality and happiness.

The POMS-SF assesses overall psychological adjustment.

This measure assesses psychological adjustment, specifically with respect to depressive symptoms.

This measure assesses psychological adjustment, specifically with respect to anxiety

The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.

The SSC measures partners' perceived support of their female partners

Canadian Breast Cancer Foundation

Sunnybrook Health Sciences Centre

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Sarcoma

Trophoblastic Neoplasms

Neoplasms, Germ Cell and Embryonal

Fallopian Tube Neoplasms

Endometrial Neoplasms

Peritoneal Neoplasms

Germinoma

Ovarian Neoplasms

Gestational Trophoblastic Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Fallopian Tube Diseases

Adnexal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Vulvar Diseases

Vaginal Diseases

Pregnancy Complications, Neoplastic

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Fallopian Tube Cancer

Vulvar Cancer

Ovarian Germ Cell Tumor

Gestational Trophoblastic Tumor

Uterine Sarcoma

Central Nervous System Germinoma

Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.

Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

behavioral, psychological or informational intervention

Participate in psychological intervention

Kristen M. Carpenter, Ph.D

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

Psychosexual Intervention for Gynecologic and Breast Cancer Patients

Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained.

Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain. Items are rated using the Likert scales. 95% confidence intervals will be obtained.

95% confidence intervals will be obtained.

The Likert scale will be used. 95% confidence intervals will be obtained.

The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer	NCT01881022	Breast Cancer	Psychosexual In...	- 80 Years	Sunnybrook Health Sciences Centre
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer	NCT01881022	Breast Cancer	Psychosexual In...	- 80 Years	Sunnybrook Health Sciences Centre
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer	NCT01764802	Ovarian Sarcoma Ovarian Stromal... Stage I Uterine... Stage I Vaginal... Stage I Vulvar ... Stage IA Cervic... Stage IA Endome... Stage IA Fallop... Stage IA Ovaria... Stage IA Ovaria... Stage IA Primar... Stage IB Cervic... Stage IB Endome... Stage IB Fallop... Stage IB Ovaria... Stage IB Ovaria... Stage IB Primar... Stage IC Fallop... Stage IC Ovaria... Stage IC Ovaria... Stage IC Primar... Stage II Endome... Stage II Gestat... Stage II Uterin... Stage II Vagina... Stage II Vulvar... Stage IIA Cervi... Stage IIA Fallo... Stage IIA Ovari... Stage IIA Ovari... Stage IIA Prima... Stage IIB Cervi... Stage IIB Fallo... Stage IIB Ovari... Stage IIB Ovari... Stage IIB Prima... Stage IIC Fallo... Stage IIC Ovari... Stage IIC Ovari... Stage IIC Prima... Stage III Gesta... Stage III Uteri... Stage III Vagin... Stage III Vulva... Stage IIIA Cerv... Stage IIIA Endo... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIA Ovar... Stage IIIA Prim... Stage IIIB Cerv... Stage IIIB Endo... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIB Ovar... Stage IIIB Prim... Stage IIIC Endo... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Ovar... Stage IIIC Prim... Breast Cancer	behavioral, psy... behavioral, psy...	21 Years - 80 Years	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for psychosexual intervention