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NCT07829367

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2029-09-30

Last Updated

2026-09-21

Healthy Volunteers

Yes

Conditions

Prostate Cancer Patients Sexual Dysfunctions

Interventions

BEHAVIORAL

Dyadic STEP-SexPCare

Dyadic STEP-SexPCare is a culturally tailored, nurse-led, couple-based psychosexual intervention for prostate cancer survivors and their female partners. The programme contains six core components delivered over a planned 6 weeks, with a 6-8-week completion window: four approximately 60-minute live dyadic sessions and two 20-30-minute self-paced modules with brief nurse check-ins. Session 1 is face-to-face; Sessions 3, 5, and 6 are delivered via Zoom. Content includes psychoeducation, communication coaching, mindfulness/grounding, non-demand intimacy exercises, sexual adaptation, management of masculinity and self-image concerns, shared planning, and an Intimacy Maintenance Plan. Each live session uses the Screen-Tailor-Escalate-Plan workflow, including safety screening and referral when needs exceed nursing scope

OTHER

Standard Survivorship Care

It is a standard survivorship care that the hopsitals provided.

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.