Breast Cancer FemaleNCT03624972
Addressing Sexual Concerns in Breast Cancer: Patient Intervention Study
A study testing Starting the Conversation Video and Sexual and Menopausal Health Resources in people with Breast Cancer Female, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Starting the Conversation Video and Sexual and Menopausal Health Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
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
- Being tested
- Starting the Conversation Video, Sexual and Menopausal Health Resources
- Keywords
- communication, sexual health, menopausal health
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting the Conversation VideoBehavioural
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 ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 weeks
Secondary outcomes (19)
Recruitment Rates (Feasibility)
Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.
Measured: baseline
Retention Rates (Feasibility)
Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
Measured: 2 weeks
Retention Rates (Feasibility)
Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.
Measured: 2 months
Intervention Acceptability
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.
Measured: 2 weeks
Sexual Activity
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.
Measured: 2 months
Sexual Function
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.
Measured: 2 months
General Self-Efficacy for Communication With Provider
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.
Measured: 2 months
Barriers to Communicating About Sexual Health
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.
Measured: 2 months
Self-Reported Anxiety
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.
Measured: 2 months
Self-Reported Depression
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.
Measured: 2 months
Self-Reported Quality of Life
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.
Measured: 2 months
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
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.
Measured: 2 weeks
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
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.
Measured: 2 months
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
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.
Measured: 2 weeks
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
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.
Measured: 2 months
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
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.
Measured: 2 weeks
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
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.
Measured: 2 months
Self-Reported Outcome Expectancies for Communication About Menopausal Health
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.
Measured: 2 weeks
Self-Reported Outcome Expectancies for Communication About Menopausal Health
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start27 May 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624972
- Sponsor's protocol ID
- 14-833-02
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2018
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Patient-Provider Communication About Sexual Concerns in Breast Cancer: Patient Intervention Study
- ClinicalTrials.gov ID
- NCT03624972
- Acronym / sponsor ID
- 14-833-02
- Conditions
- Breast Cancer Female
- Keywords
- communication, sexual health, menopausal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 27 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resources Only | Active comparator | Behavioral: Sexual and Menopausal Health ResourcesPatients 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. |
| Resources + Video | Experimental | Behavioral: Starting the Conversation Video, Behavioral: Sexual and Menopausal Health ResourcesPatients 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. |
| Clinician Arm | No intervention | –Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starting the Conversation VideoThe 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. | Behavioural | Resources + Video |
| Sexual and Menopausal Health ResourcesPatients 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. | Behavioural | Resources + Video, Resources Only |
Primary outcome
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
Time frame: 2 weeks
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.
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues
Time frame: 2 months
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.
Self-Reported Outcome Expectancies for Sexual Health Communication
Time frame: 2 weeks
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.
Self-Reported Outcome Expectancies for Sexual Health Communication
Time frame: 2 months
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.
Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit
Time frame: 2 weeks
As coded from clinic visit audio, the number of patients who ask at least one question about sexual health.
Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit
Time frame: 2 weeks
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).
19 secondary outcomes
Recruitment Rates (Feasibility)
Time frame: baseline
Retention Rates (Feasibility)
Time frame: 2 weeks
Retention Rates (Feasibility)
Time frame: 2 months
Intervention Acceptability
Time frame: 2 weeks
Sexual Activity
Time frame: 2 months
Sexual Function
Time frame: 2 months
General Self-Efficacy for Communication With Provider
Time frame: 2 months
Barriers to Communicating About Sexual Health
Time frame: 2 months
Self-Reported Anxiety
Time frame: 2 months
Self-Reported Depression
Time frame: 2 months
Self-Reported Quality of Life
Time frame: 2 months
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
Time frame: 2 weeks
Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects
Time frame: 2 months
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
Time frame: 2 weeks
Self-Reported Self-Efficacy for Communicating About About Menopausal Health
Time frame: 2 months
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
Time frame: 2 weeks
Self-Reported Outcome Expectancies for Communication About Treatment Side Effects
Time frame: 2 months
Self-Reported Outcome Expectancies for Communication About Menopausal Health
Time frame: 2 weeks
Self-Reported Outcome Expectancies for Communication About Menopausal Health
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starting the Conversation Video and Sexual and Menopausal Health Resources in people with Breast Cancer Female, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Self-Efficacy for Communicating About Sexual Health Issues (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.