Dyadic STEP-SexPCare for Sexual Health in Chinese Prostate Cancer Survivors and Their Female Partners
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dyadic STEP-SexPCare
BehavioralDyadic 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
Standard Survivorship Care
Other interventionIt is a standard survivorship care that the hopsitals provided.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Dyadic STEP-SexPCare Plus Standard Survivorship CareExperimental treatment 1 intervention
Group B: Standard Survivorship CareOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At completion of recruitment2
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
Time frame
At completion of recruitment3
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
Time frame
At completion of recruitment4
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.
Time frame
At initiation of the intervention following randomizationSecondary outcomes
1
Mean Expanded Prostate Cancer Index Composite-26 Sexual Domain Score
The Chinese version of the Expanded Prostate Cancer Index Composite-26 (EPIC-26) will assess prostate cancer-specific sexual functioning in male prostate cancer survivors. The sexual domain contains six items and is transformed to a score ranging from 0 to 100. Higher scores indicate better sexual functioning.
Time frame
Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)2
Mean Mutuality Scale Score
The Chinese version of the 15-item Mutuality Scale will assess mutuality and relationship quality in both prostate cancer survivors and their female partners. Items are rated from 0 (not at all) to 4 (a great deal), with higher scores indicating better mutuality.
Time frame
Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)3
Mean Medical Outcomes Study Sexual Functioning Scale Score
The Medical Outcomes Study Sexual Functioning Scale will assess sexual-function problems in both prostate cancer survivors and their female partners using four sex-specific items
Time frame
Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)4
Mean 5-Item Dyadic Coping Score
The 5-item Chinese dyadic coping measure will assess shared coping in prostate cancer survivors and their female partners. Each item is scored from 0 to 6, producing a total score from 0 to 30. Higher scores indicate better dyadic coping
Time frame
Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Chinese University of Hong Kong
Collaborator
Queen Mary Hospital, Hong Kong
Collaborator
Source ClinicalTrials.gov
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