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Trial Title:
Supportive Clinic for Patients Living With Advanced and Metastatic Cancers
NCT ID:
NCT06465511
Condition:
Cancer
Physical Symptom Distress
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Physical symptom distress
self-efficacy in managing cancer
health-related quality of life
survivorship intervention
advanced cancer
randomised controlled trial
psychooncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
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).
Intervention:
Intervention type:
Behavioral
Intervention name:
Supportive clinic
Description:
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.
Arm group label:
Supportive clinic
Intervention type:
Behavioral
Intervention name:
Control: Self-management
Description:
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.
Arm group label:
Control: Self-management
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Center of Cancer Medicine, Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Contact:
Last name:
Rina Hui
Email:
rinahui@hku.hk
Facility:
Name:
JCICC
Address:
City:
Hong Kong
Country:
Hong Kong
Facility:
Name:
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Address:
City:
Hong Kong
Country:
Hong Kong
Facility:
Name:
Queen Mary Hospital-Department of Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Facility:
Name:
Queen Mary Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Start date:
August 1, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465511
