Prostate Cancer PatientsSTEP-SexPCareNCT07829367
Dyadic STEP-SexPCare for Sexual Health in Chinese Prostate Cancer Survivors and Their Female Partners
A study testing Dyadic STEP-SexPCare and Standard Survivorship Care in people with Prostate Cancer Patients and Sexual Dysfunctions, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Patients, Sexual Dysfunctions
- What is being tested?
- Dyadic STEP-SexPCare and Standard Survivorship Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- Metastatic or terminal disease.
- Currently receiving active curative treatment.
- Severe communication or functional limitations that preclude participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer Patients, Sexual Dysfunctions
- Being tested
- Dyadic STEP-SexPCare, Standard Survivorship Care
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic STEP-SexPCareBehavioural
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 CareOther
It is a standard survivorship care that the hopsitals provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dyadic STEP-SexPCare |
| Standard Survivorship Care | Other | It is a standard survivorship care that the hopsitals provided. Receives: Other: Standard Survivorship Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)
Mean WHOQOL-BREF Physical Health Domain Score
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
Measured: Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Hammoda ABU-ODAH, Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829367
- Sponsor's protocol ID
- 08112026
- Acronym
- STEP-SexPCare
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07829367
- Acronym / sponsor ID
- STEP-SexPCare / 08112026
- Conditions
- Prostate Cancer Patients, Sexual Dysfunctions
- Keywords
- Prostate cancer survivorship, Sexual health, Sexual functioning, Psychosexual care, Dyadic intervention, Couple-based intervention, Intimacy, Mutuality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Queen Mary Hospital, Hong Kong
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dyadic STEP-SexPCare Plus Standard Survivorship Care | Experimental | Behavioral: Dyadic STEP-SexPCareCouples 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. |
| Standard Survivorship Care | Other | Other: Standard Survivorship CareIt is a standard survivorship care that the hopsitals provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male prostate cancer survivors:
- 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.
Key exclusion criteria (9 listed)
- Either member of the couple:
- Metastatic or terminal disease.
- Currently receiving active curative treatment.
- Severe communication or functional limitations that preclude participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic STEP-SexPCareDyadic 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 | Behavioural | Dyadic STEP-SexPCare Plus Standard Survivorship Care |
| Standard Survivorship CareIt is a standard survivorship care that the hopsitals provided. | Other | Standard Survivorship Care |
Primary outcome
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.
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
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
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.
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.
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.
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.
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
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.
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.
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hammoda ABU-ODAH study chair
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic STEP-SexPCare and Standard Survivorship Care in people with Prostate Cancer Patients and Sexual Dysfunctions, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAMMODA ABU-ODAH, Assistanr Professor (94983446 ext. +852, hammoda@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Screened Couples Meeting Eligibility Criteria (time frame: At completion of recruitment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.