Trial Title:
A Self-management Based Survivorship Intervention for Chinese Cancer Survivors
NCT ID:
NCT05534386
Condition:
Physical Symptom Distress
Weight Management
Neoplasms
Conditions: Keywords:
Physical symptom distress
Weight management
Self-efficacy in managing cancer
Health-related quality of life
Survivorship intervention
Sequential multiple assessment randomized controlled trial
psychooncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
First stage intervention: We will use a block randomization with randomly permuted block
sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will
be randomised to the intervention group (i.e. Cancer survivorship care intervention) or
control group (i.e. a set of pamphlets explaining symptoms and describing skill-based
self-management for symptom management and lifestyle recommendations).
Second stage intervention: We will use a block randomization with randomly permuted block
sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will
be randomised to continue in the trial as usual (i.e. those in the survivorship clinic
arm will be asked to follow the advice given by the multidisciplinary team in the initial
visit and for those in the control arm will be asked to follow the advices printed in the
skill-based self-management pamphlets) or to attend a step-up targeted personalized
intervention.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The investigator, care provider, 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
intervention or control arms.
The participants are masked in terms of not knowing that one intervention is hypothesized
to yield larger effects than the other.
Intervention:
Intervention type:
Behavioral
Intervention name:
Cancer survivorship care intervention
Description:
A one-off face-to-face assessment and personal advice by members of a multidisciplinary
team
Arm group label:
First stage intervention: Cancer survivorship care intervention (CSCI)
Intervention type:
Behavioral
Intervention name:
Step-up targeted personalized intervention
Description:
To provide a more personalized intervention to the participants, but focusing more on
symptom management and weight control.
Arm group label:
Second stage intervention: Step-up targeted personalized intervention
Intervention type:
Behavioral
Intervention name:
First stage control intervention
Description:
A set of skill-based pamphlets will be given.
Arm group label:
First stage intervention: Control intervention
Intervention type:
Behavioral
Intervention name:
Second stage control intervention
Description:
Those in the survivorship clinic arm will be asked to follow the advice given by the
multidisciplinary team in the initial visit and for those in the control arm will be
asked to follow the advices printed in the skill-based self-management pamphlet
Arm group label:
Second stage intervention: Control intervention
Summary:
This study, using a sequential multiple assessment randomized controlled trial (SMART)
approach, will evaluate a cancer survivorship care intervention on physical symptom
distress, weight management, self-efficacy in managing cancer and health-related quality
of life among Chinese patients recently completed curative cancer treatment.
Detailed description:
This study, using this SMART approach, will assess the effect of a cancer survivorship
care intervention on physical symptom distress, self-efficacy in managing cancer, weight
management and health-related quality of life among Chinese patients recently completing
curative cancer treatment. First, the investigators will test the effect of a one-off,
multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic)
with personalized advice on symptom management, lifestyle modification and anxiety
management in reducing the case prevalence of symptom distress, increasing the proportion
meeting the weight management criteria, and improving self-efficacy and health-related
quality of life among cancer survivors in post-treatment survivorship, in comparison to
those receiving skills-based pamphlets for symptom management and lifestyle
recommendations. Secondly, this study aims to explore if a step-up targeted personalized
intervention is more effective for patients who continue to have symptom distress and/or
not to meet the weight management criteria if patients have attended cancer survivorship
clinic (i.e. the embedded adaptive intervention) in comparison to those receiving
skills-based pamphlets.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
- have completed primary and adjuvant treatment within the past six months
Exclusion Criteria:
- Patients diagnosed with metastatic cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kwong Wah Hospital-Breast Center
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Pamela Youde Nethersole Eastern Hospital-Department of oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Prince of Wales Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Karen Chan
Email:
kklchan@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Wendy Chan
Email:
winglok@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Dominic Foo
Email:
ccfoo@hku.hk
Facility:
Name:
Tung Wah Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Start date:
April 12, 2023
Completion date:
October 31, 2024
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/NCT05534386
