Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Cancer; Physical Symptom Distress

Treatments: Behavioral: Supportive clinic; Behavioral: Control: Self-management

Study type: Interventional

Funder types: Other

Identifiers

NCT06465511

UW24-177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Supportive clinic

Experimental group

Description:

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.

Treatment:

Behavioral: Supportive clinic

Control: Self-management

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.

Treatment:

Behavioral: Control: Self-management