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NCT07829367Toborzás még nem indult

Dyadic STEP-SexPCare for Sexual Health in Chinese Prostate Cancer Survivors and Their Female Partners

Effects of a Culturally Tailored, Nurse-Led, Multi-Component Dyadic Psychosexual Intervention With Stepped Screening, Tailoring, and Escalation (Dyadic STEP-SexPCare) for Chinese Prostate Cancer Survivors and Their Partners: A Randomised Feasibility Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 21.

Rövid összefoglaló (regiszter, angolul)

This pilot feasibility randomized controlled trial will evaluate the feasibility, acceptability, safety, and preliminary effects of Dyadic STEP-SexPCare, a culturally tailored, nurse-led psychosexual programme for Hong Kong Chinese prostate cancer survivors and their female partners after primary treatment. Approximately 72 couples (144 participants) will be randomized 1:1 at the couple level to Dyadic STEP-SexPCare plus standard prostate cancer survivorship care or standard survivorship care alone. Dyadic STEP-SexPCare contains six core components delivered over a planned 6 weeks, with an allowable 6-8-week completion window: four live nurse-led dyadic sessions and two self-paced modules. The programme addresses sexual recovery, couple communication, intimacy, mutuality, dyadic coping, emotional adjustment, sexual adaptation, and shared intimacy planning through a Screen-Tailor-Escalate-Plan approach. Outcomes will be assessed at baseline before randomization, post-intervention at approximately Week 8, and 3 months after the intervention. The primary aim is to assess the feasibility, acceptability, safety, and implementation of the intervention and trial procedures. Secondary analyses will estimate preliminary between-group effects on sexual functioning, mutuality, dyadic coping, psychological distress, and quality of life to inform a future definitive randomized controlled trial.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
72 (tervezett)
Első benyújtás
2026. aug. 26.
Kezdés
2026. okt. 1.
Elsődleges befejezés
2029. jan. 30.
Fő szponzor
The University of Hong Kong
Betegségek
Prosztatarák
NCT-szám
NCT07829367

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 72
  • 2026. okt. 1. és az elsődleges befejezés (2029. jan. 30.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Either member of the couple:
    • Is receiving structured psychosexual therapy targeting outcomes similar to those addressed in Dyadic STEP-SexPCare.
    • Has severe cognitive impairment or uncontrolled psychiatric illness.
    • Has major medical instability that would interfere with participation.
    • Has active safety concerns requiring specialist intervention.
    • Prostate cancer survivor-specific exclusions:
  • Currently receiving active curative treatment.

Más betegség

  • Metastatic or terminal disease.

Egyéb

  • Severe communication or functional limitations that preclude participation.

Kiket keres a vizsgálat

  • Male prostate cancer survivors:
    • Diagnosed with localized prostate cancer and aged 18 years or older.
    • Completed primary prostate cancer treatment at least 12 months before enrollment and are not currently receiving active curative treatment, including surgery, chemotherapy, or radiotherapy.
    • May be receiving adjuvant androgen deprivation therapy if clinically stable.
    • Are followed by the urology, surgery, or oncology team at Prince of Wales Hospital or Queen Mary Hospital.
    • Are willing to participate in the study.
    • Are in a committed relationship with a female partner who is willing to participate.
    • Can read Chinese and communicate in Cantonese.
    • Are physically able to participate in study sessions.
    • Have no severe cognitive impairment or uncontrolled psychiatric or medical condition that would prevent participation.
    • Provide written informed consent.
    • Female partners:
  • Are the current female partner of an eligible prostate cancer survivor participating in the study.
  • Are aged 18 years or older.
  • Are willing to participate.
  • Can read Chinese and communicate in Cantonese.
  • Are physically and cognitively able to participate.
  • Provide written informed consent.
    • Dyad-level requirements:
  • Both members of the couple agree to participate.
  • Both members are willing to discuss experiences related to sexual recovery, intimacy, relationship adjustment, or couple communication after prostate cancer treatment.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

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