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

NCT07829367 | Not Yet Recruiting

• 1 other identifier: 08112026
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer Patients; Sexual Dysfunctions

Keywords

Prostate cancer survivorship; Sexual health; Sexual functioning; Psychosexual care; Dyadic intervention; Couple-based intervention; Intimacy; Mutuality; Dyadic coping; Couple communication; Female partners; Supportive care; Psycho-oncology; Cancer survivorship; Chinese couples; Hong Kong; Dyadic STEP-SexPCare

Outcome Measures

Primary Outcomes (10)

• Percentage of Screened Couples Meeting Eligibility Criteria

  Eligibility rate will be calculated as the number of couples meeting all study eligibility criteria divided by the number of couples screened, multiplied by 100.

  At completion of recruitment

• Percentage of Consented Couples Successfully Randomized

  Randomization rate will be calculated as the number of consented couples who complete the baseline assessment and are randomized divided by the number of consented couples, multiplied by 100

  At completion of recruitment

• Percentage of Eligible Couples Providing Written Informed Consent

  Consent rate will be calculated as the number of eligible couples in which both members provide written informed consent divided by the number of eligible couples, multiplied by 100. The green progression criterion is a consent rate of 60% or greater

  At completion of recruitment

• Percentage of Intervention Couples Initiating Dyadic STEP-SexPCare

  Intervention uptake will be calculated as the number of couples allocated to the intervention arm who begin Dyadic STEP-SexPCare divided by the number of couples allocated to the intervention arm, multiplied by 100.

  At initiation of the intervention following randomization

• Completion Rate of the Six Dyadic STEP-SexPCare Core Components

  For intervention couples, completion of each of the six core components will be recorded. Completion of live sessions will be determined from attendance records. Completion of self-paced Modules 2 and 4 will be determined from module completion logs, worksheet or checklist review during the nurse check-in, and intervention fidelity/dose-received documentation.

  At completion of the intervention, planned at Week 6 with an allowable completion window of Weeks 6-8

• Percentage of Intervention Couples Completing at Least Four of Six Core Components

  Dose completion rate will be calculated as the percentage of intervention couples completing at least four of the six core Dyadic STEP-SexPCare components. The green progression criterion is that at least 70% of intervention couples complete at least four of six components.

  At completion of the intervention, planned at Week 6 with an allowable completion window of Weeks 6-8

• Retention Rate at Post-Intervention and Three-Month Follow-Up

  Retention rate will be calculated as the number of randomized couples remaining in the study and completing the scheduled follow-up assessment divided by the number of randomized couples, multiplied by 100. Retention will be reported separately by study arm and at T1 and T2. The green progression criterion for T2 retention is 75% or greater.

  Immediately post-intervention, approximately Week 8 (T1), and 3 months after completion of the intervention (T2)

• Questionnaire Completion Rate

  Questionnaire completion rate will be calculated as the number of expected questionnaires completed divided by the number expected at each assessment time point, multiplied by 100. Completion will be summarized by study arm and assessment time point

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Percentage of Missing Questionnaire and Outcome Data

  The percentage of missing questionnaire items or missing outcome data will be calculated at each assessment time point. Blank, incomplete, or unreturned responses will be treated as missing as applicable. The green progression criterion is no more than 10%-15% missing data for key outcomes.

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Number of Participants With Adverse Events or Safety Concerns During the Study

  The number and nature of adverse events or safety concerns will be documented, including acute distress, severe depressive symptoms, privacy concerns, coercive dynamics, or other issues requiring session pause, referral, or withdrawal. Events will be documented with their severity and the action taken.

  From enrollment through the 3-month post-intervention follow-up assessment (T2)

Secondary Outcomes (6)

• Mean Expanded Prostate Cancer Index Composite-26 Sexual Domain Score

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Mean Mutuality Scale Score

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Mean Medical Outcomes Study Sexual Functioning Scale Score

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Mean 5-Item Dyadic Coping Score

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

• Mean Hospital Anxiety and Depression Scale Anxiety Subscale Score

  Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)

Study Arms (2)

Dyadic STEP-SexPCare Plus Standard Survivorship Care

EXPERIMENTAL

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.

Behavioral: Dyadic STEP-SexPCare

Standard Survivorship Care

OTHER

It is a standard survivorship care that the hopsitals provided.

Other: Standard Survivorship Care

Interventions

Dyadic STEP-SexPCare BEHAVIORAL

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

Dyadic STEP-SexPCare Plus Standard Survivorship Care

Standard Survivorship Care OTHER

It is a standard survivorship care that the hopsitals provided.

Standard Survivorship Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Metastatic or terminal disease.
• Currently receiving active curative treatment.
• Severe communication or functional limitations that preclude participation.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• Queen Mary Hospital, Hong Kong: collaborator

Study Officials

• Hammoda ABU-ODAH

  The University of Hong Kong

  STUDY CHAIR

Central Study Contacts

HAMMODA ABU-ODAH, Assistanr Professor

CONTACT

94983446; hammoda@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel, dyad-randomized pilot feasibility trial. Couples are randomized 1:1 using computer-generated variable block randomization with block sizes of 2, 4, and 6, stratified by recruitment site. Each couple is randomized as one unit to Dyadic STEP-SexPCare plus standard survivorship care or standard survivorship care alone.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share