Supportive Clinic for Patients Living With Advanced and Metastatic Cancers
- Conditions
- CancerPhysical Symptom Distress
- Interventions
- Behavioral: Supportive clinic
- Registration Number
- NCT06465511
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
To conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the survivorship care intervention on patient-reported outcomes, defined as symptom distress and health-related quality of life.
- Detailed Description
The primary aim of this study is to examine the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates a community-based survivorship care intervention to reduce symptom distress and improve health-related quality of life and self-management efficacy among patients with advanced or metastatic cancer. No hypothesis was proposed for this feasibility trial as the current Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials do not recommend hypothesis testing of clinical outcomes. The rationale is that pilot trials are often underpowered to detect differences, and this should be the aim of the main trial.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 68
- Patients diagnosed with advanced or metastatic cancer
- are at least 18 years of age
- physically able to attend the supportive clinic.
- Participants will be excluded from the study if they are non-Cantonese-, non-Mandarin-, or non-English-speakers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive clinic Supportive clinic Patients randomized to the intervention arm will attend a 120-minute survivorship clinic in which each participant will be assessed by members of a multidisciplinary team comprising an oncology nurse practitioner, a dietitian, a cancer exercise specialist, and a counsellor.
- Primary Outcome Measures
Name Time Method Adherence rate to intervention immediate post-intervention number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Rate of missing data baseline, 6-months and 9- months post-baseline number of participants with completed datasets for outcome measures/number of participant enrolled x 100
Rate of subject recruitment baseline number of participants consent and being randomized/number of eligible patients x 100
Rate of subject retention baseline, 6-months and 9- months post-baseline number of participants who complete follow-up assessments at 6 and 9 months post-baseline/number of participants enrolled x 100
Change of symptom distress baseline, 6-months and 9- months post-baseline The 10-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 10 symptoms commonly observed in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep. A numerical rating scale 0 (no symptom at all) to 10 (the worst possible symptom) is used to measure distress associated with each symptom. ESAS has been widely adopted worldwide for standardized symptom screening in routine cancer care including palliative care, The total scores ranges from 0 to 100, with a higher score indicating greater total symptom distress. The minimal clinically important difference for improvement of the ESAS total symptom scores is 5.7 .
change of health-related quality of life baseline, 6-months and 9- months post-baseline The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) will assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty. All of the scales range in score from 0 to 100.The 10-point EORTC-QLQ-C30 scores changes are considered to be clinically important.
- Secondary Outcome Measures
Name Time Method Change of self-efficacy baseline, 6-months and 9- months post-baseline Self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS). This is a 6-item scale assessing patients' confidence to perform six self-management behaviours. Each item is rated on a 10-point Likert scale, with a total score ranging from 6 to 60. A high score indicates high self-efficacy. It has been used with cancer patients.
Change of supportive care needs baseline, 6-months and 9- months post-baseline The Chines version of the 44-item Supportive Care Needs Survey for Partners and Caregivers (SCNS-P\&C) will be used to assess caregiver support care needs. The SCNS-P\&C assesses four domains of needs: Health care service needs, psychological and emotional needs, work and social needs, and information needs. Each item is rated on a 4-item scale (1= no need, 2 = low need, 3 = moderate need, and 4 = high need). A high score indicates greater unmet supportive care needs.
Trial Locations
- Locations (5)
Queen Mary Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Center of Cancer Medicine, Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Obstetrics & Gynaecology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
JCICC
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong