Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Patients | — | UNRESOLVED | — |
| Sexual Dysfunctions | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dyadic STEP-SexPCare | Behavioral | — | UNRESOLVED |
| Standard Survivorship Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dyadic STEP-SexPCare Plus Standard Survivorship Care
- description
- Couples allocated to this arm will receive standard prostate cancer survivorship care plus Dyadic STEP-SexPCare. The programme comprises six core components delivered over a planned 6 weeks, with an allowable 6-8-week completion window: four approximately 60-minute nurse-led dyadic sessions and two self-paced modules. Session 1 is delivered face-to-face; Sessions 3, 5, and 6 are delivered via Zoom. Self-paced modules are completed between live sessions, with brief nurse check-ins. The programme addresses sexual recovery, communication, intimacy, emotional adjustment, dyadic coping, sexual adaptation, and shared intimacy planning.
- interventionNames
- Behavioral: Dyadic STEP-SexPCare
- type
- OTHER
- label
- Standard Survivorship Care
- description
- It is a standard survivorship care that the hopsitals provided.
- interventionNames
- Other: Standard Survivorship Care
Primary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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: * Metastatic or terminal disease. * Currently receiving active curative treatment. * Severe communication or functional limitations that preclude participation.
References
Publications (0)
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