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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT).
The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.
The Psychosexual Educational Partners Program (PEPP) is a two-arm pilot randomized controlled trial that will compare two approaches to a self-paced, workbook-based intervention. PEPP was designed to enhance intimacy among breast and gynecological cancer survivors and their partners by improving sexual communication. The primary aim of the study is to assess the preliminary efficacy of the revised PEPP intervention on sexual communication. Secondary aims include assessing the preliminary efficacy of PEPP on self-efficacy to communicate about sex and intimacy among cancer survivors; and evaluating adherence, acceptance and adverse events within each study arm.
The intervention is six weeks long and does not require any in-person visits. If a breast or gynecological cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, participants will be emailed the consent form and will schedule a virtual consent/baseline visit that will include their partner. After consent is obtained from both partners, the dyad will be randomly assigned to a study arm and given study numbers. Both members of the dyad will complete online surveys at the virtual baseline visit. The PEPP workbook will be sent to the participants' address and a virtual education visit will be scheduled. At this second virtual visit, both members of the dyad will receive education about their study arm and a start date will be agreed upon for week 1. Beginning week 1 and continuing through week 6, dyads will work through the PEPP workbook which contains three modules. Participants will receive a scheduled email and/or text check-in message from study staff every two weeks to coincide with the end of each module. Messages will provide a link to a brief survey to assess adherence and respond to any participant questions or concerns. Online surveys will be repeated and adverse events will be assessed at week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Guided PEPP Intervention workbook | Experimental | Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns. |
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| Self-Guided PEPP Education Workbook | Active Comparator | Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Guided PEPP Intervention Workbook | Behavioral | The workbook contains 3 modules. To complete the workbook in six weeks (one module every 2 weeks), it is recommended that a dyad schedule at least three 30-minute blocks of time each week. Dyads are asked to work through the modules in order and encouraged to set a pace that works for them. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyadic Sexual Communication (DSC) | The preliminary efficacy of the revised PEPP intervention on sexual communication among dyads. The DSC is a single-dimensional 13-item scale that measures sexual communication between partners on a 4-point Likert scale, disagree strongly to agree strongly. Possible scores range from 13-52 with higher scores indicating better sexual communication. | consent through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy to Communicate about Sex and Intimacy (SECSI) | The SECSI is a is a 10-item scale that measures self-efficacy to communicate about sex and intimacy among women treated for cancer. Participants respond using a 4-point Likert scale, strongly agree to strongly disagree. Possible scores range from 0-30 with higher scores indicating greater self-efficacy to communicate with a partner about sex and intimacy after cancer treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants must be female breast or gynecological cancer survivors and their intimate partners.
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| Name | Affiliation | Role |
|---|---|---|
| Noel M Arring, DNP, PhD, RN | University of Tennessee Knoxville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Knoxville | Knoxville | Tennessee | 37916 | United States |
This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data-sharing requests for de-identified data as appropriate.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This is a two-arm randomized controlled trial
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single masking, participant
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| Self-Guided PEPP Education Workbook | Behavioral | The workbook contains 3 modules. To complete the workbook in six weeks (one module every 2 weeks), it is recommended that a dyad schedule at least three 30-minute blocks of time each week. Dyads are asked to work through the modules in order and encouraged to set a pace that works for them. |
|
| consent through study completion, an average of 8 weeks |
| Adherence rate | The number of PEPP modules completed by participants divided by the number of participants multiplied by 3 (the total number of modules). | consent of first participant through study completion of last participant, up to 1 year |
| Adverse events | Evaluate the adverse events in participants randomized to each study arm. | consent through study completion, an average of 8 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |