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Trial Title:
E-intervention on Subclinical Fear of Cancer Recurrence
NCT ID:
NCT06207006
Condition:
Cancer
Psychooncology
Fear of Cancer Recurrence
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A prospective, parallel RCT design will be used to assess the impact of the
eConquerFear-HK intervention on FCR improvement among Chinese cancer survivors in Hong
Kong. Participants will be randomly assigned to an intervention group or a control group
at a 1:1 ratio, using a computer-generated block randomization sequence generated by a
statistician who is blinded to the identity of participants. This allocation concealment
approach minimizes risk of selection and assessment bias. The serially labelled opaque
sealed envelope method will be used for randomization. Block randomization structure with
randomly permuted blocks sizes of 2 and 4 will be used to ensure close balance of numbers
in each arm.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The investigator, care provider, 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
control arms.
The participants are masked in terms of not knowing that the intervention,
eConquerFear-HK are hypothesized to yield larger effects than the other (i.e. control).
Intervention:
Intervention type:
Behavioral
Intervention name:
eConquerFear-HK
Description:
The key goals of the intervention are to: (i) teach strategies for controlling worry and
excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry;
(iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance
of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and
encourage engagement in values-based goal setting.
Arm group label:
eConquerFear-HK
Intervention type:
Behavioral
Intervention name:
Basic Cancer Care
Description:
Basic Cancer Care serves as an active comparator and is not developed specifically to
target fear of cancer recurrence through modifying participants' cognitive beliefs.
Participants in this arm will receive 6 videos about relaxation, generic dietary and
exercise knowledge.
Arm group label:
Basic Cancer Care
Summary:
The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based
self-management intervention, namely eConquerFear-HK and evaluate in a randomised
controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer
recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer
recurrence.
Detailed description:
A pilot randomised controlled feasibility trial will used to test the feasibility,
utility, and potential effectiveness of an internet-based self-management intervention
for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear
of cancer recurrence.
The following hypotheses will be tested:
1. There will be a greater FCR improvement in cancer survivors receiving
eConquerFear-HK intervention vs those in the active control group.
2. There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK
intervention vs those in the active control group.
3. There will be greater improvements in secondary outcomes (psychological distress and
quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those
in the active control group.
4. Cancer survivors receiving eConquerFear-HK intervention will perceive the
intervention useful for managing their FCR and be satisfied with the intervention.
5. Cancer survivors receiving eConquerFear-HK intervention will show high completion
rates.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Cantonese- or Mandarin-speaking Chinese cancer survivors
- recently diagnosed with potentially curable (stage 0 to III) colorectal or breast
cancer
- had recently completed surgery as primary treatment
- have completed hospital-based adjuvant treatments (including radiotherapy and
chemotherapy) within the past six months
- scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.
Exclusion Criteria:
- non-Chinese ethnicity
- metastatic cancer
- with current diagnosis of depression or psychosis or are currently receiving
psychological treatments
- language or intellectual difficulties that prevent them from understanding the
intervention content
- having limited or no Internet access.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
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
Start date:
May 2, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Health and Medical Research Fund
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/NCT06207006
