Supportive Clinic for Patients Living With Advanced and Metastatic Cancers
NCT Number: NCT06465511
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Physical Symptom Distress
Interventions: BEHAVIORAL: Supportive clinic|BEHAVIORAL: Control: Self-management
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31
Locations: Center of Cancer Medicine, Queen Mary Hospital, Hong Kong, Hong Kong|JCICC, Hong Kong, Hong Kong|Queen Mary Hospital-Department of Obstetrics & Gynaecology, Hong Kong, Hong Kong|Queen Mary Hospital-Department of Oncology, Hong Kong, Hong Kong|Queen Mary Hospital-Department of Surgery, Hong Kong, Hong Kong

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.

Primary Outcome Measures: Rate of subject recruitment, number of participants consent and being randomized/number of eligible patients x 100, baseline|Rate of subject retention, number of participants who complete follow-up assessments at 6 and 9 months post-baseline/number of participants enrolled x 100, baseline, 6-months and 9- months post-baseline|Adherence rate to intervention, number of participants who complete the intervention/number of being allocated to attend the intervention x 100, immediate post-intervention|Rate of missing data, number of participants with completed datasets for outcome measures/number of participant enrolled x 100, baseline, 6-months and 9- months post-baseline|Change of symptom distress, 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 ., baseline, 6-months and 9- months post-baseline|change of health-related quality of life, 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., baseline, 6-months and 9- months post-baseline
Secondary Outcome Measures: Change of self-efficacy, 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., baseline, 6-months and 9- months post-baseline|Change of supportive care needs, 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., baseline, 6-months and 9- months post-baseline