Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

NCT06465511 | Not Yet Recruiting

• 1 other identifier: UW24-177
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cancer; Physical Symptom Distress

Keywords

Physical symptom distress; self-efficacy in managing cancer; health-related quality of life; survivorship intervention; advanced cancer; randomised controlled trial; psychooncology

Outcome Measures

Primary Outcomes (6)

• Rate of subject recruitment

  number of participants consent and being randomized/number of eligible patients x 100

  baseline

• 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

• 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 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 Outcomes (2)

• Change of self-efficacy

  baseline, 6-months and 9- months post-baseline

• Change of supportive care needs

  baseline, 6-months and 9- months post-baseline

Study Arms (2)

Supportive clinic

EXPERIMENTAL

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

Control: Self-management

ACTIVE COMPARATOR

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

Interventions

Supportive clinic BEHAVIORAL

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.

Supportive clinic

Control: Self-management BEHAVIORAL

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.

Control: Self-management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (5)

Center of Cancer Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Location

JCICC

Hong Kong, Hong Kong

Location

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, Hong Kong

Location

Queen Mary Hospital-Department of Oncology

Hong Kong, Hong Kong

Location

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wendy Lam, Phd

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Lam, Phd

CONTACT

+852 39179878; wwtlam@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to the intervention or the control arm. The participants are masked in terms of not knowing that the intervention are hypothesized to yield larger effects than the others (i.e. controls).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-arm feasibility trial study with an intervention group and a control group. Computer-generated block randomization sequences will be generated by a statistician who is blinded to the identity of participants prior to the start of the trial. A block randomisation structure with randomly permuted block sizes of 2 and 4 will be used to reduce selection bias and ensure close balance of the numbers in each arm. The serially labelled opaque sealed envelope method will be used for randomisation.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 20, 2024
• Study Start: February 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (5)