A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Cancer survivorship care intervention

    Behavioral

    A one-off face-to-face assessment and personal advice by members of a multidisciplinary team

  • Step-up targeted personalized intervention

    Behavioral

    To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.

  • First stage control intervention

    Behavioral

    A set of skill-based pamphlets will be given.

  • Second stage control intervention

    Behavioral

    Those 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

486 Participants
are divided into 4 treatment groups
Group A: First stage intervention: Cancer survivorship care intervention (CSCI)Experimental treatment 1 intervention
Group B: First stage intervention: Control interventionActive comparator 1 intervention
Group C: Second stage intervention: Step-up targeted personalized interventionExperimental treatment 1 intervention
Group D: Second stage intervention: Control interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12-months post-baseline
2

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.

Time frame
12-months post-baseline
3

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.

Time frame
Baseline and 12-months post-baseline

Secondary outcomes

1

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.

Time frame
Baseline, 4-months post-baseline, and 12 months post-baseline
2

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.

Time frame
Baseline, 4-months post-baseline, and 12 months post-baseline
3

Illness perception

Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).

Time frame
Baseline, 4-months post-baseline, and 12 months post-baseline
4

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.

Time frame
12-months post-baseline

Other outcomes

1

Demographic data

Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire.

Time frame
Baseline
2

Clinical data

Clinical data will be extracted from medical records.

Time frame
Baseline, 4-months post-baseline, and 12 months post-baseline
3

Lifestyle behavior

Lifestyle behavior e.g. drinking and smoking habit will be assessed using a single item question.

Time frame
Baseline, 4-months post-baseline, and 12 months post-baseline

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