Breast Cancer Female
Conditions
Keywords
communication, sexual health, menopausal health
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.
Interventions
BEHAVIORALStarting 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.
BEHAVIORALSexual 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.
Sponsors
American Cancer Society, Inc.
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | 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 Outcome Expectancies for Sexual Health Communication | 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. |
| Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function | 2 months | 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. |
| General Self-Efficacy for Communication With Provider | 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 (Range: 5-25). Higher scores indicate higher self-efficacy. |
| Barriers to Communicating About Sexual Health | 2 months | 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. |
| Self-Reported Anxiety | 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. |
| Self-Reported Depression | 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. |
| Recruitment Rates (Feasibility) | baseline | Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study. |
| Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | 2 weeks | 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. |
| Self-Reported Self-Efficacy for Communicating About About Menopausal Health | 2 weeks | 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. |
| Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | 2 weeks | 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. |
| Self-Reported Outcome Expectancies for Communication About Menopausal Health | 2 weeks | 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. |
| Self-Reported Quality of Life | 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. |
| Retention Rates (Feasibility) | 2 weeks | Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment. |
| Intervention Acceptability | 2 weeks | 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 | 2 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants complete consent and baseline survey before being assigned to a study group.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 71 |
| 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.
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. | 73 |
| Clinician Arm Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data was not collected from clinician participants. | 9 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Resources Only | Resources + Video | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 10.9 | 55.8 years STANDARD_DEVIATION 11.2 | 56.0 years STANDARD_DEVIATION 11 |
| Barriers to Communicating About Sexual Health | 29.6 score on a scale STANDARD_DEVIATION 8.9 | 30.5 score on a scale STANDARD_DEVIATION 9.9 | 30.1 score on a scale STANDARD_DEVIATION 9.4 |
| Breast Cancer Stage Stage I | 35 Participants | 31 Participants | 66 Participants |
| Breast Cancer Stage Stage II | 18 Participants | 23 Participants | 41 Participants |
| Breast Cancer Stage Stage III | 8 Participants | 8 Participants | 16 Participants |
| Breast Cancer Stage Stage IV | 10 Participants | 11 Participants | 21 Participants |
| Chemotherapy Received No chemotherapy | 27 Participants | 22 Participants | 49 Participants |
| Chemotherapy Received Received chemotherapy | 44 Participants | 51 Participants | 95 Participants |
| Education Level Completed college/graduate school | 40 Participants | 37 Participants | 77 Participants |
| Education Level High school or GED | 12 Participants | 12 Participants | 24 Participants |
| Education Level Some college | 17 Participants | 22 Participants | 39 Participants |
| Education Level Some high school | 2 Participants | 2 Participants | 4 Participants |
| Employment Status Full or part time | 39 Participants | 40 Participants | 79 Participants |
| Employment Status Retired | 18 Participants | 15 Participants | 33 Participants |
| Employment Status Unemployed/disability/other | 14 Participants | 18 Participants | 32 Participants |
| Endocrine Therapy Received No endocrine therapy | 14 Participants | 23 Participants | 37 Participants |
| Endocrine Therapy Received Received endocrine therapy | 57 Participants | 50 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 70 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| General Self-Efficacy for Communication With Provider | 21.6 score on a scale STANDARD_DEVIATION 3.4 | 21.1 score on a scale STANDARD_DEVIATION 3.4 | 21.3 score on a scale STANDARD_DEVIATION 3.4 |
| Immunotherapy Received Immunotherapy received | 26 Participants | 22 Participants | 48 Participants |
| Immunotherapy Received No immunotherapy | 45 Participants | 51 Participants | 96 Participants |
| Menopausal Status Post-menopausal | 53 Participants | 53 Participants | 106 Participants |
| Menopausal Status Pre-menopausal/peri-menopausal | 18 Participants | 20 Participants | 38 Participants |
| Months Since Breast Cancer Diagnosis | 56.6 months STANDARD_DEVIATION 64.4 | 43.8 months STANDARD_DEVIATION 42.6 | 50.12 months STANDARD_DEVIATION 54.64 |
| Outcome Expectancies for Communicating About Sexual Health Issues | 7.6 score on a scale STANDARD_DEVIATION 2.4 | 7.4 score on a scale STANDARD_DEVIATION 2.6 | 7.5 score on a scale STANDARD_DEVIATION 2.4 |
| Ovarian Suppression Therapy Received No ovarian suppression therapy | 67 Participants | 69 Participants | 136 Participants |
| Ovarian Suppression Therapy Received Ovarian suppression therapy received | 4 Participants | 4 Participants | 8 Participants |
| Patient Anxiety | 7.3 score on a scale STANDARD_DEVIATION 4.2 | 7.5 score on a scale STANDARD_DEVIATION 4.6 | 7.4 score on a scale STANDARD_DEVIATION 4.4 |
| Patient Depression | 4.4 score on a scale STANDARD_DEVIATION 3.4 | 5.3 score on a scale STANDARD_DEVIATION 4 | 4.9 score on a scale STANDARD_DEVIATION 3.7 |
| Quality of Life | 61.9 score on a scale STANDARD_DEVIATION 14.3 | 60.8 score on a scale STANDARD_DEVIATION 16.7 | 61.3 score on a scale STANDARD_DEVIATION 15.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 26 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 53 Participants | 43 Participants | 96 Participants |
| Radiation Therapy Received No radiation | 23 Participants | 29 Participants | 52 Participants |
| Radiation Therapy Received Radiation received | 48 Participants | 44 Participants | 92 Participants |
| Relationship Status In a romantic relationship | 46 Participants | 51 Participants | 97 Participants |
| Relationship Status Not in a romantic relationship | 25 Participants | 22 Participants | 47 Participants |
| Self-Efficacy for Communicating About Sexual Health Issues | 7.7 score on a scale STANDARD_DEVIATION 2.4 | 7.4 score on a scale STANDARD_DEVIATION 2.6 | 7.5 score on a scale STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 71 Participants | 73 Participants | 144 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sexual Activity Not sexually active | 35 Participants | 32 Participants | 67 Participants |
| Sexual Activity Refused to answer | 1 Participants | 0 Participants | 1 Participants |
| Sexual Activity Sexually active | 35 Participants | 41 Participants | 76 Participants |
| Sexual Function Sexual interest | 35.6 t-score STANDARD_DEVIATION 9.9 | 36.6 t-score STANDARD_DEVIATION 11.9 | 36.1 t-score STANDARD_DEVIATION 11 |
| Sexual Function Sexual satisfaction | 46.3 t-score STANDARD_DEVIATION 8.1 | 46.0 t-score STANDARD_DEVIATION 9.1 | 46.2 t-score STANDARD_DEVIATION 8.6 |
| Sexual Function Vaginal discomfort | 56.1 t-score STANDARD_DEVIATION 10.7 | 58.0 t-score STANDARD_DEVIATION 11.1 | 57.2 t-score STANDARD_DEVIATION 10.9 |
| Sexual Function Vaginal lubrication | 42.8 t-score STANDARD_DEVIATION 10.1 | 41.6 t-score STANDARD_DEVIATION 8.1 | 42.2 t-score STANDARD_DEVIATION 9 |
| Sexual Orientation Bisexual | 0 Participants | 1 Participants | 1 Participants |
| Sexual Orientation Heterosexual/straight | 70 Participants | 70 Participants | 140 Participants |
| Sexual Orientation Homosexual/lesbian | 1 Participants | 2 Participants | 3 Participants |
| Surgery Received Breast conserving (lumpectomy) | 43 Participants | 40 Participants | 83 Participants |
| Surgery Received Mastectomy without reconstruction | 2 Participants | 7 Participants | 9 Participants |
| Surgery Received Mastectomy with reconstruction | 23 Participants | 23 Participants | 46 Participants |
| Surgery Received No surgery | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 73 | 0 / 9 |
| other Total, other adverse events | 0 / 71 | 0 / 73 | 0 / 9 |
| serious Total, serious adverse events | 0 / 71 | 0 / 73 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 2 weeks
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Only | Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit | 12 Participants |
| Resources + Video | Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit | 25 Participants |
Primary
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).
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Only | Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit | 14 Participants |
| Resources + Video | Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit | 20 Participants |
Primary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Sexual Health Communication | 8.2 score on a scale | Standard Deviation 2.2 |
| Resources + Video | Self-Reported Outcome Expectancies for Sexual Health Communication | 8.4 score on a scale | Standard Deviation 2 |
Primary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Sexual Health Communication | 7.8 score on a scale | Standard Deviation 2.1 |
| Resources + Video | Self-Reported Outcome Expectancies for Sexual Health Communication | 7.8 score on a scale | Standard Deviation 2.2 |
Primary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | 8.5 score on a scale | Standard Deviation 1.8 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | 8.8 score on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | 7.8 score on a scale | Standard Deviation 2 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | 8.2 score on a scale | Standard Deviation 2.2 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Barriers to Communicating About Sexual Health | 29.0 score on a scale | Standard Deviation 9 |
| Resources + Video | Barriers to Communicating About Sexual Health | 27.8 score on a scale | Standard Deviation 9.9 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | General Self-Efficacy for Communication With Provider | 21.6 score on a scale | Standard Deviation 3.5 |
| Resources + Video | General Self-Efficacy for Communication With Provider | 22.2 score on a scale | Standard Deviation 3 |
Secondary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Resources Only | Intervention Acceptability | Satisfied/Very Satisfied | 64 Participants |
| Resources Only | Intervention Acceptability | Dissatisfied/Very Dissatisfied | 0 Participants |
Secondary
Recruitment Rates (Feasibility)
Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study.
Time frame: baseline
Population: 177 eligible candidates were approached for participation in the intervention trial.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Only | Recruitment Rates (Feasibility) | 144 Participants |
Secondary
Retention Rates (Feasibility)
Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Only | Retention Rates (Feasibility) | 69 Participants |
| Resources + Video | Retention Rates (Feasibility) | 71 Participants |
Secondary
Retention Rates (Feasibility)
Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Resources Only | Retention Rates (Feasibility) | 71 Participants |
| Resources + Video | Retention Rates (Feasibility) | 71 Participants |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Anxiety | 7.3 score on a scale | Standard Deviation 4.2 |
| Resources + Video | Self-Reported Anxiety | 6.6 score on a scale | Standard Deviation 4.9 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Depression | 4.4 score on a scale | Standard Deviation 3.5 |
| Resources + Video | Self-Reported Depression | 4.6 score on a scale | Standard Deviation 3.7 |
Secondary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Communication About Menopausal Health | 8.6 score on a scale | Standard Deviation 1.7 |
| Resources + Video | Self-Reported Outcome Expectancies for Communication About Menopausal Health | 8.7 score on a scale | Standard Deviation 2 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Communication About Menopausal Health | 8.3 score on a scale | Standard Deviation 1.8 |
| Resources + Video | Self-Reported Outcome Expectancies for Communication About Menopausal Health | 8.7 score on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | 8.6 score on a scale | Standard Deviation 1.5 |
| Resources + Video | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | 8.8 score on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | 8.9 score on a scale | Standard Deviation 1.4 |
| Resources + Video | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | 9.2 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Quality of Life | 62.6 score on a scale | Standard Deviation 13.9 |
| Resources + Video | Self-Reported Quality of Life | 61.8 score on a scale | Standard Deviation 18.2 |
Secondary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | 9.1 score on a scale | Standard Deviation 1.6 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | 9.4 score on a scale | Standard Deviation 1.5 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | 9.0 score on a scale | Standard Deviation 1.4 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | 9.3 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | 9.1 score on a scale | Standard Deviation 1.3 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | 9.3 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resources Only | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | 9.3 score on a scale | Standard Deviation 1.5 |
| Resources + Video | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | 9.5 score on a scale | Standard Deviation 1.3 |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Resources Only | Sexual Activity | Sexually active | 32 Participants |
| Resources Only | Sexual Activity | Not sexually active | 37 Participants |
| Resources + Video | Sexual Activity | Sexually active | 50 Participants |
| Resources + Video | Sexual Activity | Not sexually active | 21 Participants |
Secondary
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resources Only | Sexual Function | Vaginal lubrication | 42.2 t-score | Standard Deviation 8.5 |
| Resources Only | Sexual Function | Vaginal discomfort | 55.8 t-score | Standard Deviation 11.8 |
| Resources Only | Sexual Function | Sexual satisfaction | 44.7 t-score | Standard Deviation 7.3 |
| Resources Only | Sexual Function | Sexual interest | 35.7 t-score | Standard Deviation 9.7 |
| Resources + Video | Sexual Function | Sexual interest | 37.8 t-score | Standard Deviation 11.2 |
| Resources + Video | Sexual Function | Vaginal lubrication | 41.6 t-score | Standard Deviation 9.7 |
| Resources + Video | Sexual Function | Sexual satisfaction | 46.3 t-score | Standard Deviation 8.5 |
| Resources + Video | Sexual Function | Vaginal discomfort | 58.4 t-score | Standard Deviation 11.1 |