A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Neoplasms; Physical Symptom Distress; Weight Management

Treatments: Behavioral: Step-up targeted personalized intervention; Behavioral: Second stage control intervention; Behavioral: First stage control intervention; Behavioral: Cancer survivorship care intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05534386

UW20-100

Details and patient eligibility

About

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.

Full description

This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.

Enrollment: 486 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
• have completed primary and adjuvant treatment within the past six months

Exclusion criteria

• Patients diagnosed with metastatic cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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486 participants in 4 patient groups

First stage intervention: Cancer survivorship care intervention (CSCI)

Experimental group

Description:

Patients randomized to the CSCI will attend a 120-minutes survivorship clinic in which each participant will be assessed by members a multidisciplinary team comprising a registered nurse, a dietitian, an exercise physiologist and a psychologist/counsellor. During the visit, participants will receive a personalized (1) treatment summary, (2) assessment and recommendation on managing physical and psychological symptoms, (3) assessment and recommendation on dietary advice, (4) assessment and recommendation on physical activity, and (5) advice on managing potential psychosocial issues. While this is a multidisciplinary clinic, the nurse will be the core facilitator who will give a summary of health assessment report including personalized healthy lifestyle advice and action plan to each participant at the end of the visit.

Treatment:

Behavioral: Cancer survivorship care intervention

First stage intervention: Control intervention

Active Comparator group

Description:

Patients randomized to the control group will be given a set of pamphlets explaining symptoms and describing skill-based self-management for symptom management and lifestyle recommendations. Each pamphlet addresses one of the 7 most commonly-reported symptoms (sleep difficulties, fatigue, neuropathy, pain, anxiety, depression, and fear of cancer recurrence) observed in Hong Kong cancer survivors, plus two on lifestyle recommendations (physical activity and healthy diet). All pamphlets are developed based on the self-management framework.

Treatment:

Behavioral: First stage control intervention

Second stage intervention: Step-up targeted personalized intervention

Experimental group

Description:

The step-up targeted personalized intervention will adopt a multi-disciplinary approach but place more emphasis on coaching to enhance patient' skills to manage their symptom burden and weight control.

Treatment:

Behavioral: Step-up targeted personalized intervention

Second stage intervention: Control intervention

Active Comparator group

Description:

Patients randomized to the control arm at the re-assessment at 4-months post-baseline will continue in the trial as usual (i.e. 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 pamphlets).

Treatment:

Behavioral: Second stage control intervention