Breast Cancer Clinical Trial
— PEPPOfficial title:
Psychosexual Educational Partners Program (PEPP): Randomized Phase II Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 female. 2. Able to read and write in English. 3. History of any stage of breast and/or gynecological cancer. 4. Completed primary treatment (chemotherapy, radiation and/or surgery) = 3 months and = 5 years prior to registration. 5. May use maintenance therapy and concurrent adjuvant endocrine therapy or human epidermal growth factor receptor 2 negative (HER2-) targeted therapy while on study. 6. Have a stable partner, defined as anyone with whom the woman has had an intimate relationship for at least 3 months prior to her cancer diagnosis. 7. Responds yes to the question "Has there been a change in communication and/or intimacy with your partner since your cancer diagnosis?" 8. Both partner and woman patient must agree to participate in the study and sign informed consent to the study. 9. Psychiatric medications such as antidepressants and benzodiazepines are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change. Exclusion Criteria: 1. Past history of sexual abuse. 2. Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (Defined per medical history and/or patient self-report). 3. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed). |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee Knoxville | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
The University of Tennessee, Knoxville |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | consent through study completion, an average of 8 weeks | |
Secondary | 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 | |
Secondary | Adverse events | Evaluate the adverse events in participants randomized to each study arm. | consent through study completion, an average of 8 weeks |
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