NCT Number: NCT06465511
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Center of Cancer Medicine, Queen Mary Hospital, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During the visit, each patient will receive a personalized feedback summary, including an assessment and recommendation on managing physical and psychological symptoms, an evaluation and recommendation on dietary advice, an assessment and recommendation on physical activity, and advice on managing potential psychosocial issues by the multidisciplinary team.
Each pamphlet given to the patients addresses one of the 7 most commonly-reported symptoms (sleep difficulties, fatigue, neuropathy, pain, anxiety, depression, and fear of cancer progression) observed in Hong Kong patients with advanced or metastatic cancer, plus two on lifestyle recommendations (physical activity and eating well). All pamphlets are developed based on the self-management framework.
Time frame: baseline
number of participants consent and being randomized/number of eligible patients x 100
Time frame: 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
Time frame: immediate post-intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Time frame: baseline, 6-months and 9- months post-baseline
number of participants with completed datasets for outcome measures/number of participant enrolled x 100
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Danielle Ng, Phd
CONTACT
Wendy Lam, Phd
CONTACT
The University of Hong Kong
Other
Survivorship Intervention for Patients Living With Advanced and Metastatic Cancers: a Randomized Controlled Feasibility Study
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