Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

Survivorship Intervention for Patients Living With Advanced and Metastatic Cancers: a Randomized Controlled Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Physical Symptom Distress
• Intervention / Treatment: Behavioral: Supportive clinic; Behavioral: Control: Self-management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Lam, PhD; Phone Number: +852 39179878; Email: wwtlam@hku.hk

Study Locations

• Hong Kong
  • 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
    • Center of Cancer Medicine, Queen Mary Hospital
    • Contact: Rina Hui; Email: rinahui@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with advanced or metastatic cancer
• are at least 18 years of age
• physically able to attend the supportive clinic.

Exclusion Criteria:

• Participants will be excluded from the study if they are non-Cantonese-, non-Mandarin-, or non-English-speakers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive clinic; Patients randomized to the intervention arm will attend a 120-minute survivorship clinic in which each participant will be assessed by members of a multidisciplinary team comprising an oncology nurse practitioner, a dietitian, a cancer exercise specialist, and a counsellor.	Behavioral: Supportive clinic; 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.
Active Comparator: Control: Self-management; 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.	Behavioral: Control: Self-management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of subject recruitment	number of participants consent and being randomized/number of eligible patients x 100	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 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
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wendy Lam, PhD, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: randomised controlled trial; advanced cancer; health-related quality of life; Physical symptom distress; psychooncology; self-efficacy in managing cancer; survivorship intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: UW24-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No