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NCT07829367Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
72 (estimated)
First submitted
26 Aug 2026
Start date
1 Oct 2026
Primary completion date
30 Jan 2029
Lead sponsor
The University of Hong Kong
NCT number
NCT07829367

What you commit to

  • Study type: Interventional
  • Planned participants: 72
  • From 1 Oct 2026 to the primary completion date, 30 Jan 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Metastatic or terminal disease.

Other

  • Severe communication or functional limitations that preclude participation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.