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NCT Number: NCT07829367

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

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.

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Key information

Conditions

Prostate Cancer Patients Sexual Dysfunctions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Sexual dysfunction and changes in intimacy are common after prostate cancer treatment and can affect both survivors and their partners. In Hong Kong Chinese couples, sexual recovery may also be influenced by culturally embedded concerns including shame, loss of face, masculinity-related concerns, indirect communication, avoidance, and fear of burdening one's partner. Dyadic STEP-SexPCare was developed to address sexual functioning together with couple communication, emotional validation, mutuality, dyadic coping, and intimacy negotiation.

This study is a two-arm, assessor-blinded pilot feasibility randomized controlled trial with a nested qualitative process evaluation. Approximately 72 couples will be randomized in a 1:1 ratio to Dyadic STEP-SexPCare plus standard prostate cancer survivorship care or standard survivorship care alone. Randomization will use computer-generated variable block sizes of 2, 4, and 6 and will be stratified by recruitment site. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes opened after completion of baseline assessments.

Dyadic STEP-SexPCare is a culturally tailored, nurse-led, couple-based psychosexual intervention guided by the Systemic-Transactional Model of Dyadic Coping and the Ex-PLISSIT framework. The programme comprises six core components: four live nurse-led dyadic sessions and two self-paced modules. The planned programme duration is 6 weeks, with an allowable 6-8-week completion window. Session 1 is delivered face-to-face in a private setting; Sessions 3, 5, and 6 are delivered via Zoom. The self-paced modules address masculinity, self-image, emotional reactions, sexual adaptation, and broadened sexual scripts. Educational materials, worksheets, and home-practice activities are provided between sessions.

Each live session uses a Screen-Tailor-Escalate-Plan workflow. The nurse screens for privacy, distress, relational safety, and the couple's priorities; tailors discussion and support to the couple's needs and comfort; escalates concerns beyond nursing scope to appropriate clinical, mental-health, relationship, or specialist sexual-medicine services; and develops a shared recovery and intimacy plan with the couple. The intervention progresses from permission-giving and normalization to communication coaching, non-demand intimacy, sexual adaptation, troubleshooting, and development of an Intimacy Maintenance Plan.

Participants allocated to the control arm receive standard prostate cancer survivorship care, including routine follow-up and advice if sexual concerns are raised during usual care. Educational materials will be offered after completion of the final T2 assessment.

Questionnaires are completed by survivors and female partners at baseline before randomization (T0), post-intervention at approximately Week 8 (T1), and 3 months after the intervention (T2). Feasibility, acceptability, safety, intervention uptake, retention, questionnaire completion, and missing-data indicators will be assessed. Preliminary clinical outcomes include prostate cancer-specific sexual functioning, sexual functioning in both partners, mutuality, dyadic coping, anxiety, depression, and quality of life.

A nested qualitative process evaluation will invite approximately 25-30 participants from the study arms for individual semi-structured interviews. Survivor and partner interviews will be conducted separately to explore acceptability, cultural fit, sensitive-topic communication, intervention delivery, study burden, barriers and facilitators to engagement, and recommendations for refinement before a definitive randomized controlled trial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Survivorship Care

Other

It is a standard survivorship care that the hopsitals provided.

Primary outcomes

  1. Percentage of Screened Couples Meeting Eligibility Criteria

    Time frame: At completion of recruitment

    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.

  2. Percentage of Consented Couples Successfully Randomized

    Time frame: At completion of recruitment

    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

  3. Percentage of Eligible Couples Providing Written Informed Consent

    Time frame: At completion of recruitment

    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

  4. Percentage of Intervention Couples Initiating Dyadic STEP-SexPCare

    Time frame: At initiation of the intervention following randomization

    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.

  5. Completion Rate of the Six Dyadic STEP-SexPCare Core Components

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

    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.

  6. Percentage of Intervention Couples Completing at Least Four of Six Core Components

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

    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.

  7. Retention Rate at Post-Intervention and Three-Month Follow-Up

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

    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.

  8. Questionnaire Completion Rate

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

    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

  9. Percentage of Missing Questionnaire and Outcome Data

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

    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.

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

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

    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.

Secondary outcomes

  1. Mean Expanded Prostate Cancer Index Composite-26 Sexual Domain Score

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

    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.

  2. Mean Mutuality Scale Score

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

    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.

  3. Mean Medical Outcomes Study Sexual Functioning Scale Score

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

    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

  4. Mean 5-Item Dyadic Coping Score

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

    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

  5. Mean Hospital Anxiety and Depression Scale Anxiety Subscale Score

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

    The Chinese Hospital Anxiety and Depression Scale (HADS) anxiety subscale contains seven items. Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.

  6. Mean WHOQOL-BREF Physical Health Domain Score

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

    The Chinese WHOQOL-BREF will assess physical health quality of life. Domain scores will be transformed according to the scoring algorithm for the validated version used in this study. Higher scores indicate better quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

HAMMODA ABU-ODAH, Assistanr Professor

CONTACT

[email protected]

94983446 ext. +852

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong
  • Queen Mary Hospital, Hong Kong

Registry information

Official study 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

Acronym: STEP-SexPCare

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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