Psychosexual Educational Partners Program (PEPP): Randomized Phase II Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dyadic Sexual Communication (DSC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
single masking, participant
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 female.
- •Able to read and write in English.
- •History of any stage of breast and/or gynecological cancer.
- •Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 10 years prior to registration.
- •May use maintenance therapy and concurrent adjuvant endocrine therapy or human epidermal growth factor receptor 2 negative (HER2-) targeted therapy while on study.
- •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.
- •Responds yes to the question "Has there been a change in communication and/or intimacy with your partner since your cancer diagnosis?"
- •Both partner and woman patient must agree to participate in the study and sign informed consent to the study.
- •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.
排除标准
- •Past history of sexual abuse.
- •Uncontrolled psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, or schizophrenia (Defined per medical history and/or patient self-report).
- •Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
结局指标
主要结局
Dyadic Sexual Communication (DSC)
时间窗: consent through study completion, an average of 8 weeks
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.
次要结局
- Adherence rate(consent of first participant through study completion of last participant, up to 1 year)
- Self-Efficacy to Communicate about Sex and Intimacy (SECSI)(consent through study completion, an average of 8 weeks)
- Adverse events(consent through study completion, an average of 8 weeks)