Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

NCT03624972 | Completed Results

• 1 other identifier: 14-833-02
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.

Conditions

Breast Cancer Female

Keywords

communication; sexual health; menopausal health

Outcome Measures

Primary Outcomes (6)

• Self-Reported Self-Efficacy for Communicating About Sexual Health Issues

  Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.

  2 weeks

• Self-Reported Self-Efficacy for Communicating About Sexual Health Issues

  Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy.

  2 months

• Self-Reported Outcome Expectancies for Sexual Health Communication

  Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.

  2 weeks

• Self-Reported Outcome Expectancies for Sexual Health Communication

  Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes.

  2 months

• Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit

  As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.

  2 weeks

• Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit

  As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred).

  2 weeks

Secondary Outcomes (19)

• Recruitment Rates (Feasibility)

  baseline

• Retention Rates (Feasibility)

  2 weeks

• Retention Rates (Feasibility)

  2 months

• Intervention Acceptability

  2 weeks

• Sexual Activity

  2 months

Study Arms (3)

Resources Only

ACTIVE COMPARATOR

Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit.

Behavioral: Sexual and Menopausal Health Resources

Resources + Video

EXPERIMENTAL

Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit.

Behavioral: Starting the Conversation Video; Behavioral: Sexual and Menopausal Health Resources

Clinician Arm

NO INTERVENTION

Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants.

Interventions

Starting the Conversation Video BEHAVIORAL

The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.

Resources + Video

Sexual and Menopausal Health Resources BEHAVIORAL

Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal \& sexual health clinic.

Resources + Video; Resources Only

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving any treatment for breast cancer or have completed acute treatment for breast cancer \< 10 years ago
• Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
• Willing to have clinic visit audio recorded

You may not qualify if:

• Unable to speak English
• Eastern Cooperative Oncology Group (ECOG) Performance score \> 2 OR too ill to participate as judged by physician, self-report, or observation of the research team member
• Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Communication

Interventions

Sex

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Dr. Jennifer Reese, Associate Professor
• Organization: Fox Chase Cancer Center

Jennifer.Reese@fccc.edu

215-214-3223

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 10, 2018
• Study Start: May 27, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)