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Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

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ClinicalTrials.gov Identifier: NCT03624972
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: Starting the Conversation Video Behavioral: Sexual and Menopausal Health Resources Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
Actual Study Start Date : May 27, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resources Only
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
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.

Experimental: Resources + Video
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
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.

Behavioral: Sexual and Menopausal Health Resources
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.

No Intervention: Clinician Arm
Seven clinicians will be consented to this study in order to have their clinic visits with the participating patients audio recorded. Only demographic information will be collected from the clinicians via self-report.



Primary Outcome Measures :
  1. Change in Self-Reported Self-Efficacy for Communicating About Sexual Health Issues [ Time Frame: baseline, 2 weeks , 2 months ]
    Patients' self-reported self-efficacy for communication about sexual health concerns with their breast cancer provider. The items about sexual health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about sexual health and asking her provider about sexual health. Response options range from 0 (not at all confident) to 10 (extremely confident).

  2. Change in Self-Reported Outcome Expectancies for Sexual Health Communication [ Time Frame: baseline, 2 weeks, 2 months ]
    Patients' outcome expectancies for communicating with their breast cancer providers about sexual health (i.e., their beliefs that communicating about sexual health will lead to positive outcomes), measured through a 5-item scale. Response options range from 0 (not at all) to 10 (very much).

  3. Percentage of clinic visits where patient asks at least one question about sexual health [ Time Frame: 2 weeks ]
    As coded from clinic visit audio, the percentage of visits where the patient asks at least one question about sexual health during their encounter.

  4. Percentage of clinic visits where patient initiates conversation about sexual health [ Time Frame: 2 weeks ]
    As coded from clinic visit audio, the percentage of visits where the patient raises the topic of sexual health during their encounter.


Secondary Outcome Measures :
  1. Recruitment rates (Feasibility) [ Time Frame: baseline ]
    Recruitment rates, as measured by percentage of patients enrolled out of patients approached for the study.

  2. Retention rates (Feasibility) [ Time Frame: 2 weeks and 2-months ]
    Retention rates, as measured by percentage of patients who remain on study for follow-up assessments

  3. Intervention Acceptability [ Time Frame: 2 weeks ]
    Acceptability of study, as measured through responses on Program Evaluation

  4. Sexual Function [ Time Frame: baseline and 2 months ]
    Patient sexual function, as measured through the Patient Reported Outcomes Measurement Information System Sexual Function (PROMIS SexFS) Brief Profile (Female)

  5. Change in general Self-Efficacy for Communication with Provider [ Time Frame: baseline, 2 weeks, 2 months ]
    Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5). The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers. Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score. Higher scores indicate higher self-efficacy.

  6. Change in Self-Efficacy for Menopausal Health Communication [ Time Frame: baseline, 2 weeks, 2 months ]
    Self-reported self-efficacy for communicating with providers about menopausal health. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 1 (not at all confident) to 10 (extremely confident).

  7. Change in Self-Efficacy for Communication about Treatment-Related Side Effects [ Time Frame: baseline, 2 weeks, 2 months ]
    Self-reported self-efficacy for communicating with providers about treatment-related side effects. The items about treatment-related side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment-related side effects and asking her provider about treatment-related side effects. Response options range from 1 (not at all confident) to 10 (extremely confident).

  8. Change in Outcome Expectancies for Communication about Menopausal Health [ Time Frame: baseline, 2 weeks, 2 months ]
    Patients' self-reported outcome expectancies for communicating with their breast cancer providers about menopausal health, (i.e., their beliefs that communicating about menopausal health will lead to positive outcomes), measured through a 5-item scale. Response options range from 0 (not at all) to 10 (very much).

  9. Change in Outcome Expectancies for Communication about Treatment-Related Side Effects [ Time Frame: baseline, 2 weeks, 2 months ]
    Patients' outcome expectancies for communicating with their breast cancer providers about side effects of treatment, (i.e., their beliefs that communicating about treatment-related side effects in general will lead to positive outcomes), measured through a 5-item scale. Response options range from 0 (not at all) to 10 (very much).

  10. Change in Barriers to Communicating about Sexual Health [ Time Frame: baseline and 2 months ]
    Patient barriers to communication about sexual health, as measured through a 14-item scale. Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed"). Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree. A mean barrier score will be taken from this scale.

  11. Change in Patient Anxiety [ Time Frame: baseline and 2 months ]
    Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety.

  12. Change in Patient Depression [ Time Frame: baseline and 2 months ]
    Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression.

  13. Change in Patient Quality of Life [ Time Frame: baseline and 2 months ]
    Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score. The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer. Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unable to speak English
  2. 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
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624972


Contacts
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Contact: Jennifer B Reese, PhD 215-214-3223 jennifer.reese@fccc.edu
Contact: Kristen A Sorice, BA 215-214-1433 kristen.sorice@fccc.edu

Locations
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United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Kristen Sorice, BA    215-214-1433    kristen.sorice@fccc.edu   
Principal Investigator: Jennifer B Reese, PhD         
Sponsors and Collaborators
Fox Chase Cancer Center
American Cancer Society, Inc.

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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT03624972     History of Changes
Other Study ID Numbers: 14-833-02
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fox Chase Cancer Center:
communication
sexual health
menopausal health

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases