Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

NCT ID: NCT06465511

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Physical Symptom Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Supportive clinic

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Control: Self-management

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wendy Lam, Phd

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center of Cancer Medicine, Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

JCICC

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital-Department of Oncology

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital-Department of Surgery

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wendy Lam, Phd

Role: CONTACT

+852 39179878

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rina Hui

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UW24-177

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.