Clinical trial NCT06465511: Supportive Clinic for Patients Living With Advanced and Metastatic Cancers
Official title: Survivorship Intervention for Patients Living With Advanced and Metastatic Cancers: a Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of subject recruitment
timeFrame: baseline
measure: Rate of subject retention
timeFrame: baseline, 6-months and 9- months post-baseline
measure: Adherence rate to intervention
timeFrame: immediate post-intervention
measure: Rate of missing data
timeFrame: baseline, 6-months and 9- months post-baseline
measure: Change of symptom distress
timeFrame: baseline, 6-months and 9- months post-baseline
measure: change of health-related quality of life
timeFrame: baseline, 6-months and 9- months post-baseline
Secondary outcomes:
measure: Change of self-efficacy
timeFrame: baseline, 6-months and 9- months post-baseline
measure: Change of supportive care needs
timeFrame: baseline, 6-months and 9- months post-baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Center of Cancer Medicine, Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: JCICC
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Obstetrics & Gynaecology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Lam, Phd
role: PRINCIPAL_INVESTIGATOR
References: