Health TrialsbyHealthPanel

Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

ConditionsProstate CancerUrinary IncontinenceErectile Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorDuke University

About this trial

This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.

All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.

Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Biopsy-confirmed localized prostate adenocarcinoma.

Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.

Initiating pelvic floor physical therapy as part of routine clinical care.

Disqualifiers

Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.

Recieved non-nerve-sparing treatment (when applicable).

Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.

Need for additional or secondary prostate cancer treatment during the intervention period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sex Therapy

    Behavioral

    Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (\~45 minutes) over 6 months delivered by a psychologist.

  • Pelvic Floor Physical Therapy

    Behavioral

    Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.

  • Vacuum Erection Device (VED)

    Device

    FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PFPT + Sex TherapyExperimental treatment 3 interventions
Group B: PFPT Alone (Standard Care)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment feasibility as measured by number of participants recruited

Accrual rate will be used to assess feasibility of recruiting participants to the study target of 30 participants. This feasibility trial is designed to estimate key process parameters with precision rather than to test efficacy hypotheses

Time frame
From initiation of recruitment to completion of accrual, up to 1 year
2

Enrollment feasibility, as measured by consent rate

Consent rate will be used to assess enrollment feasibility. This measure reflects the proportion of eligible participants who provide informed consent after screening and outreach.

Time frame
From initiation of recruitment to completion of accrual, up to 1 year
3

Randomization feasibility

Randomization rate will be used to assess the proportion of consented eligible participants who are randomized in a 1:1 ratio to pelvic floor physical therapy (PFPT) plus sex therapy or PFPT alone.

Time frame
From initiation of recruitment to completion of accrual, up to 1 year
4

Retention feasibility

Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.

Time frame
12 months

Secondary outcomes

1

Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised

Participants assigned to sex therapy will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the sex therapy they are currently attending or have completed. The first 12 items assess agreement with statements related to therapy and therapist satisfaction on a 5-point scale from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks how much the treatment helped with the specific problem that led the participant to therapy, with response options ranging from "made things a lot better" to "made things a lot worse."

Time frame
6 Months
2

Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised

Participants in both arms will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to pelvic floor physical therapy. The first 12 items assess agreement with statements related to therapy and therapist satisfaction on a 5-point scale from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks how much the treatment helped with the specific problem or concern that led the participant to therapy, with response options ranging from "made things a lot better" to "made things a lot worse."

Time frame
12 Months
3

Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL)

The International Prostate Symptom Score with bother index/quality-of-life assessment is an 8-item measure that will be used to assess urinary symptoms and urinary-related bother. The first 7 questions assess symptom severity and scores may range from 1 to 35, where higher scores indicate higher symptom severity. The final question assesses urinary-related bother on a scale of 0 to 6, where a higher score indicates higher bother.

Time frame
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
4

Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5)

The International Index of Erectile Function-5 will be used to assess erectile function. At screening, if a pretreatment IIEF-5 is not available in the medical record, a screening IIEF-5 will be collected post-treatment with recall anchored to the month prior to treatment. Sum scores range from 5 to 25, where higher scores indicate higher erectile dysfunction.

Time frame
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months

Other outcomes

1

Acceptability of Intervention Measure (AIM)

The Acceptability of Intervention Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."

Time frame
12 Months
2

Intervention Appropriateness Measure (IAM)

The Intervention Appropriateness Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."

Time frame
12 Months
3

Feasibility of Intervention Measure (FIM)

The Feasibility of Intervention Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."

Time frame
12 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

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