Clinical trial NCT05070299: Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study
Official title: Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Gynecologic Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: The Breast Cancer Research Foundation
First posted: 2021-10-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Eligibility Criteria below apply only to the patient. (The patient's partner must be 18 years of age or older.)

Patient Inclusion Criteria:

1. Age ≥18 female with a history of any stage breast and/or gynecological cancer.
2. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration.
3. May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
4. Responds yes to the question "Has there been change in communication and/or intimacy with your partner since your cancer diagnosis?"
5. Ability to read and write English.
6. 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.
7. Both partner and woman must agree to participate in the study and sign informed consent to the study.

Patient Exclusion Criteria:

1. 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.
2. Past history of sexual abuse.
3. Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
4. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).

Primary outcomes:
measure: Attrition rate (feasibility)
timeFrame: Week 6 (+2 weeks)
Secondary outcomes:
measure: Home practice rate (acceptability)
timeFrame: Week 6 (+2 weeks)
measure: Participant experience assessed using Thematic Analysis
timeFrame: Week 6 (+2 weeks)
measure: Impact of intervention, measured by Dyadic Sexual Communication (DSC)
timeFrame: Baseline to week 6 (+2 weeks)
measure: Impact of intervention, measured by PROMIS® Sexual Function and Satisfaction V2.0 (PROMIS SexF V2)
timeFrame: Baseline to week 6 (+2 weeks)
measure: Impact of intervention, measured by Revised Dyadic Adjustment Scale (RDAS)
timeFrame: Baseline to week 6 (+2 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Noel Arring, DNP, PhD, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References: