Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Attrition rate (feasibility)
研究概览
简要总结
This is a single arm study to evaluate the feasibility, adherence, and usefulness of a psychosexual education partner program (PEPP) to improve partner communication and sexual function. This study is intended to get initial input from a small group of up to 10 women and their partners about the appropriateness, usefulness, and critical nature of the content as well as the feasibility and appeal of the method of delivery.
详细描述
The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast or gynecologic cancer. The investigators are developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vaginal symptoms, desire/energy, and relationship-partner concerns. This proposal addresses the evaluation of this last component, relationship-partner concerns. The planned intervention to address these concerns is a psychosexual education partner program (PEPP) delivered by workbook and three follow up phone calls (to coincide with the end of each module) to women and their partners who have experienced a negative change in their relationship since their cancer diagnosis. Ten women with breast or gynecological cancer and their stable partners (ten dyads) will evaluate the content and delivery method of the intervention through self-report questionnaires and a qualitative interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria below apply only to the patient. (The patient's partner must be 18 years of age or older.)
- •Patient Inclusion Criteria:
- •Age ≥18 female with a history of any stage breast and/or gynecological cancer.
- •Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration.
- •May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
- •Responds yes to the question "Has there been change in communication and/or intimacy with your partner since your cancer diagnosis?"
- •Ability to read and write English.
- •A stable partner, defined as anyone with whom the woman has had an intimate relationship with for at least 3 months prior to her cancer diagnosis.
- •Both partner and woman must agree to participate in the study and sign informed consent to the study.
排除标准
- •Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.
- •Past history of sexual abuse.
- •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).
研究组 & 干预措施
Psychosexual Educational Partners Program (PEPP)
Women and their partners will work through a three module workbook together, completing each module over a 2-week period (6 weeks total).
干预措施: Psychosexual Educational Partner Program (PEPP) (Behavioral)
结局指标
主要结局
Attrition rate (feasibility)
时间窗: Week 6 (+2 weeks)
After completion of each module the interventionist will contact patients and their partners by phone and document completion of the module's exercise. Anyone who does not provide data both before and after completing the surveys for the study will be considered to be prematurely withdrawn and included in the attrition count. The intervention will be considered feasible if the attrition rate is 25% or less at week 6 (+2 weeks). Withdrawal reasons will be captured and reported by category.
次要结局
- Participant experience assessed using Thematic Analysis(Week 6 (+2 weeks))
- Home practice rate (acceptability)(Week 6 (+2 weeks))
- Impact of intervention, measured by Dyadic Sexual Communication (DSC)(Baseline to week 6 (+2 weeks))
- Impact of intervention, measured by PROMIS® Sexual Function and Satisfaction V2.0 (PROMIS SexF V2)(Baseline to week 6 (+2 weeks))
- Impact of intervention, measured by Revised Dyadic Adjustment Scale (RDAS)(Baseline to week 6 (+2 weeks))