Breast CancerPEPPNCT06253182
Psychosexual Educational Partners Program (PEPP)
A study testing Self-Guided PEPP Intervention Workbook and Self-Guided PEPP Education Workbook in people with Breast Cancer and Gynecologic Cancer, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer, Sexual Dysfunction
- What is being tested?
- Self-Guided PEPP Intervention Workbook and Self-Guided PEPP Education Workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Knoxville
Knoxville, Tennessee, 37916
About this study
Official 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.
Read the detailed description
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.
- Being tested
- Self-Guided PEPP Intervention Workbook, Self-Guided PEPP Education Workbook
- Keywords
- breast cancer, gynecologic cancer, sexual dysfunction, partner communication, couples, intimacy, sexual health
- Medical subject headings
- Breast Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided PEPP Intervention WorkbookBehavioural
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.
Self-Guided PEPP Education WorkbookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Guided PEPP Intervention Workbook |
| 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. Receives: Behavioral: Self-Guided PEPP Education Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: consent through study completion, an average of 8 weeks
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: consent through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 Apr 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Noel M Arring, DNP, PhD, RN, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253182
- Sponsor's protocol ID
- UTK IRB-23-07925-XP
- Acronym
- PEPP
- Status last verified
- Jun 2025
- First submitted
- 25 Jan 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosexual Educational Partners Program (PEPP): Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT06253182
- Acronym / sponsor ID
- PEPP / UTK IRB-23-07925-XP
- Keywords
- breast cancer, gynecologic cancer, sexual dysfunction, partner communication, couples, intimacy, sexual health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Self-Guided PEPP Intervention workbook | Experimental | Behavioral: Self-Guided PEPP Intervention WorkbookFollowing 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. |
| Self-Guided PEPP Education Workbook | Active comparator | Behavioral: Self-Guided PEPP Education WorkbookFollowing 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Guided PEPP Intervention WorkbookThe 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. | Behavioural | Self-Guided PEPP Intervention workbook |
| Self-Guided PEPP Education WorkbookThe 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. | Behavioural | Self-Guided PEPP Education Workbook |
Primary outcome
Dyadic Sexual Communication (DSC)
Time frame: 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.
3 secondary outcomes
Self-Efficacy to Communicate about Sex and Intimacy (SECSI)
Time frame: consent through study completion, an average of 8 weeks
Adherence rate
Time frame: consent of first participant through study completion of last participant, up to 1 year
Adverse events
Time frame: consent through study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel M Arring, DNP, PhD, RN principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided PEPP Intervention Workbook and Self-Guided PEPP Education Workbook in people with Breast Cancer and Gynecologic Cancer, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyadic Sexual Communication (DSC) (time frame: consent through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.