About this trial
This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
have completed primary and adjuvant treatment within the past six months
Disqualifiers
Patients diagnosed with metastatic cancer
Trial design
Sequential
Treatments tested in this trial
Cancer survivorship care intervention
BehavioralA one-off face-to-face assessment and personal advice by members of a multidisciplinary team
Step-up targeted personalized intervention
BehavioralTo provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
First stage control intervention
BehavioralA set of skill-based pamphlets will be given.
Second stage control intervention
BehavioralThose in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlet
Treatment groups
Trial outcomes
Primary outcomes
Proportion of symptom distress caseness (distress prevalence)
The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =\>7 will be categorized as moderate-to-severe symptom distress cases.
Proportion of patients with suboptimal weight control
Anthropometric measures include weight, height, and body composition, which will be measured in light clothing and without shoes. Weight and body composition including body fat, total body water, muscle mass, bone mass and BMI will be measured using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). Height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.
Change in total score 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.
Secondary outcomes
Change in total scores of self-efficacy
The process outcome is change in total scores of self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS) from baseline to 4-months post-baseline, and baseline to 12 months post-baseline. 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. A high score indicates high self-efficacy.
Fear of cancer recurrence
The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.
Illness perception
Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).
Proportion of symptom distress caseness (distress prevalence)
The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =\>7 will be categorized as moderate-to-severe symptom distress cases.
Other outcomes
Demographic data
Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire.
Clinical data
Clinical data will be extracted from medical records.
Lifestyle behavior
Lifestyle behavior e.g. drinking and smoking habit will be assessed using a single item question.
Sponsors and contacts
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