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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Percentage of Screened Couples Meeting Eligibility Criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dyadic STEP-SexPCare Plus Standard Survivorship Care
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.
干预措施: Dyadic STEP-SexPCare (Behavioral)
Standard Survivorship Care
It is a standard survivorship care that the hopsitals provided.
干预措施: Standard Survivorship Care (Other)
结局指标
主要结局
Percentage of Screened Couples Meeting Eligibility Criteria
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Mean WHOQOL-BREF Physical Health Domain Score(Baseline, pre-intervention (T0); immediately post-intervention, approximately Week 8 (T1); and 3 months after completion of the intervention (T2))