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Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment (RESTORE-PC)

30. června 2026 aktualizováno: Duke University

RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This is a two-arm, parallel-group, randomized feasibility trial conducted at Duke University Health System. Eligible adult men treated for localized prostate adenocarcinoma with erectile nerve-sparing radical prostatectomy, radiotherapy, or cryoablation at Duke Health who are initiating pelvic floor physical therapy (PFPT) will be randomized 1:1 to PFPT plus sex therapy or PFPT alone. PFPT is delivered as part of routine clinical survivorship care. All enrolled participants will receive penile rehabilitation education and a vacuum erection device (VED) as part of standard PFPT, in addition to clinician-prescribed PDEi if applicable.

The sex therapy intervention is delivered by telehealth as 10 sessions of approximately 45 minutes over 6 months. Baseline assessment occurs after completion of localized treatment and before initiation of study-linked rehabilitation.

Patient-reported outcome measures will be collected at baseline and at 3, 6, 9, 12, 18, and 24 months post-baseline for feasibility of longer follow-up. Semi-structured qualitative interviews will be offered at 6 and 12 months post-baseline.

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • North Carolina
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Rebecca A Shelby, PhD
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria

  • 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.
  • Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.
  • Able to read and understand English to complete patient-reported outcome measures.
  • Ability to provide informed consent.

Exclusion Criteria

  • 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.
  • Documented cognitive impairment or impairment that would interfere with participation.
  • Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.
  • Inability to complete study video visits or questionnaires.
  • History of prior local or systemic treatment for prostate cancer

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PFPT + Sex Therapy
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
Behaviorální: Sex Therapy
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.
Behaviorální: Pelvic Floor Physical Therapy
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
Přístroj: Vacuum Erection Device (VED)
FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.
Aktivní komparátor: PFPT Alone (Standard Care)
Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.
Behaviorální: Pelvic Floor Physical Therapy
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
Přístroj: Vacuum Erection Device (VED)
FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment feasibility as measured by number of participants recruited
Časové okno: From initiation of recruitment to completion of accrual, up to 1 year
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
From initiation of recruitment to completion of accrual, up to 1 year
Enrollment feasibility, as measured by consent rate
Časové okno: From initiation of recruitment to completion of accrual, up to 1 year
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.
From initiation of recruitment to completion of accrual, up to 1 year
Randomization feasibility
Časové okno: From initiation of recruitment to completion of accrual, up to 1 year
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.
From initiation of recruitment to completion of accrual, up to 1 year
Retention feasibility
Časové okno: 12 months
Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.
12 months
Number of participants who complete study assessments
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Assessment completion will be used to assess feasibility of longitudinal data collection across the planned study schedule. Scheduled patient-reported outcome assessments occur at baseline and during follow-up contacts.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Number of participants who participate in pelvic floor physical therapy (PFPT)
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes participation in PFPT.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Number of participants who participate in sex therapy
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes sex therapy participation in the intervention arm.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Number of participants who use recommended penile rehabilitation
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes recommended penile rehabilitation use patterns including vacuum erection device (VED) and PDE-5i use as measured via adherence logs.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Fidelity-monitoring feasibility
Časové okno: During the 6-Month sex therapy intervention window
Fidelity-monitoring feasibility will be assessed using audio recording of sex therapy sessions and audit of a planned 20% sample of recordings using fidelity checklists.
During the 6-Month sex therapy intervention window

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Časové okno: 6 Months
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."
6 Months
Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Časové okno: 12 Months
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."
12 Months
Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL)
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
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.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5)
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
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.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Sexual function and satisfaction as measured by the PROMIS Sexual Function and Satisfaction Male Brief Profile
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
The PROMIS Sexual Function and Satisfaction Measure male brief profile is an 8-item measure used to capture sexual function, sexual satisfaction, and reasons for no sexual activity without requiring partner status. Scores range from 5 to 40, where higher scores indicate higher sexual function and satisfaction.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
General health status and utility as measured by the PROMIS-16 Profile v2.1 (PROPr)
Časové okno: Baseline and 12 Months
PROMIS-16 Profile v2.1 (PROPr) is a 16-item measure used to assess general health status and utility. Scores range from 16 to 80, with higher scores indicating worse health status and utility.
Baseline and 12 Months
General health status and utility as measured by the PROMIS Global Health
Časové okno: Baseline and 12 Months
PROMIS Global Health is a 10-item measure used to assess general health status and utility. The first 9 items are measured on a 5-point Likert scale, for sum scores of 9 to 45, where higher scores indicate better general health status. The 10th item asks respondents to rate their pain on average in the past 7 days on a 10-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Baseline and 12 Months
Depressive sympoms as measured by the Patient Health Questionnaire-8 scale
Časové okno: Baseline and 12 Months
The Patient Health Questionnaire-8 will be used to assess depressive symptoms and psychosocial context. The Patient Health Questionnaire-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Baseline and 12 Months
Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale
Časové okno: Baseline and 12 Months
The Generalized Anxiety Disorder-7 questionnaire will be used to assess anxiety symptoms and psychosocial context. The Generalized Anxiety Disorder-7 score ranges from 0 to 21, where a higher score indicates greater anxiety.
Baseline and 12 Months
Trauma-related symptoms as measured by Primary Care PTSD Screen
Časové okno: Baseline and 12 Months
The Primary Care PTSD Screen for DSM-5 (PC PTSD-5) is a 5-item measure used to assess trauma-related symptoms and psychosocial context. Scores range from 0 to 5, where the score is a count of 'yes' responses to 5 yes or no questions about the impact of the trauma in the previous month.
Baseline and 12 Months
Physical activity, as measured by the International Physical Activity Questionnaire
Časové okno: Baseline and 12 Months
The International Physical Activity Questionnaire (IPAQ) short form will be used to assess physical activity. The IPAQ is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven days.
Baseline and 12 Months
Continence as measured by Continence Diary - Pad Count
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
The Continence Diary - Pad Count will be used to assess pad use and continence patterns. Participants will record pad use for 7 typical days. Social continence is defined as 0 to 1 pad per day.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Use of medications and sexual aids as measured by Medication and Sexual Aids Inventory and Use Log
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
The Medication and Sexual Aids Inventory and Use Log will be used to track use of medications and sexual aids. The log captures whether items were used since the last survey, frequency, typical duration, and notes such as side effects, discomfort, bruising, and adjunct use.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Adherence and Barriers to Adherence
Časové okno: Baseline and 12 Months
Study-specific adherence and barrier items will be used to understand what makes the rehabilitation program easier or harder to follow. Items address PFPT adherence and barriers, sex therapy adherence and barriers if assigned, and VED use adherence and barriers.
Baseline and 12 Months
PDE5 inhibitor medication adherence, as measured by Screening Tool for AdheRence to medicineS (15-STARS ED)
Časové okno: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
The 15-STARS ED is a 15-item self-report questionnaire used to assess adherence to phosphodiesterase type 5 inhibitor medication when prescribed by the treating clinician. Sum scores range from 0 to 14 with higher scores indicating lower adherence.
Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Sexual avoidance as measured by a Sexual Avoidance Questionnaire
Časové okno: Baseline and 12 Months
Sexual avoidance will be assessed using a 4-item sexual avoidance questionnaire. This measure asks respondents to indicate how often they have avoided partnered and unpartnered sexual activity, respectively, on a scale of 0 (Never) to 4 (Always or Almost Always). If a response other than 0 is provided, respondents will be asked to check all options that apply from a list of reasons why they have avoided that type of sexual activity.
Baseline and 12 Months
Sexual self-efficacy as measured by the Sexual Self-Efficacy Questionnaire
Časové okno: Baseline and 12 Months
Sexual self-efficacy will be assessed using the 26-item Sexual Self-Efficacy Questionnaire. Participants indicate which activities they believe they can do and rate their confidence in being able to perform those activities on a 10 to 100 scale.
Baseline and 12 Months
Sexual satisfaction as measured by a Sexual Satisfaction Questionnaire
Časové okno: Baseline and 12 Months
Sexual satisfaction will be assessed using the Sexual Satisfaction Questionnaire, a 4-item measure assessing respondents' agreement with 4 statements related to sexual satisfaction on a scale of 1 (Not at all) to 7 (Extremely). Higher scores indicate higher sexual satisfaction.
Baseline and 12 Months
Sexual dysfunction as measured by a Sexual Dysfunction Questionnaire
Časové okno: Baseline and 12 Months
Sexual dysfunction will be assessed using a Sexual Dysfunction Questionnaire, a 4-item measure assessing respondents' agreement with 4 statements related to sexual dysfunction on a scale of 1 (Extremely) to 6 (None or Never). Higher scores indicate higher sexual dysfunction.
Baseline and 12 Months
Sexual health information and support needs
Časové okno: Baseline and 12 Months
A study-spcific Sexual Health Information and Support Needs questionnaire will be used to assess the importance of educational and supportive programming topics related to sexual health after prostate cancer treatment. Respondents will be asked to rate the importance of 12 related topics on a scale of 1 (Unimportant) to 5 (Very important). Respondents will also have the option to self-specify 'other' topics and rate the importance of those topics.
Baseline and 12 Months
Patient perceptions and opinions about guidelines
Časové okno: Baseline and 12 Months
Patient perceptions and opinions about guidelines will be assessed using 3 study-specific guideline perception items included in the questionnaire set.
Baseline and 12 Months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Acceptability of Intervention Measure (AIM)
Časové okno: 12 Months
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."
12 Months
Intervention Appropriateness Measure (IAM)
Časové okno: 12 Months
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."
12 Months
Feasibility of Intervention Measure (FIM)
Časové okno: 12 Months
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."
12 Months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Duke University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Rebecca A Shelby, PhD, Duke University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2028

Dokončení studie (Odhadovaný)

1. července 2028

Termíny zápisu do studia

První předloženo

12. června 2026

První předloženo, které splnilo kritéria kontroly kvality

30. června 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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