Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

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.

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.

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

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.

Starting the Conversation Video

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.

Sexual and Menopausal Health Resources

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.

Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study

Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study

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.

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.

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

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).

Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.

Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.

Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.

Acceptability of intervention, as measured through the item "Overall, how satisfied were you with this program?". Responses options include Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. Responses of "satisfied" or "very satisfied" indicate acceptability. Number of patients reporting acceptability and number of patients not reporting acceptability are presented.

Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days.

Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction scale (PROMIS SexFS) Brief Profile Version 2.0. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10). Higher scores for all domains except Vaginal Discomfort signify better function.

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 (Range: 5-25). Higher scores indicate higher self-efficacy.

Patient barriers to communication about sexual health, as measured through a 13-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 total barrier score will be taken from this scale (Range: 13-65). Higher scores indicate more perceived barriers to communication.

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.

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.

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.

Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment 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 side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.

Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. 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 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported.

Five items assessed the belief that discussing treatment side effects 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.

Five items assessed the belief that discussing menopausal 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.

American Cancer Society, Inc.

Fox Chase Cancer Center

An adverse event is defined as a distress reaction during any study event, including survey completion and intervention participation.

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.

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.

Resources Only

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.

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.

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.

Resources + Video

Clinicians were consented in order to have their clinic visits audio recorded.

Clinician Arm

Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data was not collected from clinician participants.

Total

Baseline/outcomes data was not analyzed from clinician participants (N=9)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Months Since Breast Cancer Diagnosis

Relationship Status

Education Level

Employment Status

Sexual Orientation

Menopausal Status

Breast cancer stage was assigned by their oncologist using AJCC 7th and 8th edition staging criteria, with stage I having the best prognosis and stage IV having the worst prognosis.

Breast Cancer Stage

Surgery Received

Chemotherapy Received

Endocrine Therapy Received

Ovarian Suppression Therapy Received

Radiation Therapy Received

Immunotherapy Received

Self-Efficacy for Communicating About Sexual Health Issues

Outcome Expectancies for Communicating About Sexual Health Issues

Vaginal lubrication

Vaginal discomfort

Sexual satisfaction

Sexual interest

Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the PROMIS SexFS Brief Profile Version 2.0. Higher scores for all domains except Vaginal Discomfort signify better function. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10).

The sexual interest item was administered to all participants, and the lubrication, vaginal discomfort, and satisfaction items were only administered to participants who reported being sexually active. Baseline/outcomes data was not analyzed from clinician participants (N=9)

Sexual Function

General Self-Efficacy for Communication With Provider

Patient barriers to communication about sexual health, as measured through a 13-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 and are summed for a total Barrier score (Range: 13-65). Higher scores indicate more perceived barriers to communication.

Barriers to Communicating About Sexual Health

Patient Anxiety

Patient Depression

Quality of Life

Sexual Activity

Dr. Jennifer Reese, Associate Professor

All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment.

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

69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up.

Self-Reported Outcome Expectancies for Sexual Health Communication

64/71 participants in the Resources Only arm and 63/73 participants in the Resources + Video arm had their clinic encounters audio recorded and coded. Common reasons why encounters were not recorded include scheduling issues (patient canceled/rescheduled her appointment or attended at a time when recorders were not available) and patient being seen by a non-participating provider (i.e., a provider that did not agree to have their visits audio recorded).

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

Encounters where the provider raised the topic of sexual health were excluded from this analysis, as it is not known whether the patient would have raised the topic had the provider not raised it first.

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

Recruitment rates are calculated for all potential study candidates.

All Participants

177 eligible candidates were approached for participation in the intervention trial.

Recruitment Rates (Feasibility)

Retention Rates (Feasibility)

Resources + Video Group Only

Participants who did not complete the intervention (i.e., reported not watching the vide) and did not complete the 2-week survey were not administered this item. 64/73 participants both completed the intervention and the 2-week follow-up survey.

Intervention Acceptability

Sexually active

Not sexually active

69/71 Resources Only and 71/73 Resources + Video participants completed the 2-month follow-up. Only participants who reported being sexually active in the past month were given the items regarding vaginal lubrication, vaginal discomfort, and sexual satisfaction (32/69 Resources Only patients and 50/71 Resources + Video patients). All participants were given the item on sexual interest.

Self-Reported Anxiety

Self-Reported Depression

Self-Reported Quality of Life

Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects

Self-Reported Self-Efficacy for Communicating About About Menopausal Health

Self-Reported Outcome Expectancies for Communication About Treatment Side Effects

Self-Reported Outcome Expectancies for Communication About Menopausal Health

Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data were not collected from clinician participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study	NCT03624972	Breast Cancer F...	Starting the Co... Sexual and Meno...	21 Years -	Fox Chase Cancer Center
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study	NCT03624972	Breast Cancer F...	Starting the Co... Sexual and Meno...	21 Years -	Fox Chase Cancer Center
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study	NCT03624972	Breast Cancer F...	Starting the Co... Sexual and Meno...	21 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for sexual and menopausal health resources