Clinical trial NCT06207006: E-intervention on Subclinical Fear of Cancer Recurrence
Official title: Conquering Fear Online: a Pilot Randomised Controlled Trial Assessing the Efficacy and Feasibility of an Internet-based Self-management Intervention on Subclinical Fear of Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Psychooncology
Fear of Cancer Recurrence
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-01-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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.

Primary outcomes:
measure: Rate of subject recruitment
timeFrame: baseline
measure: Rate of subject retention
timeFrame: baseline,3-months post-intervention and 6-months post-intervention
measure: Adherence rate to intervention
timeFrame: the immediate post-intervention
measure: Intervention utility
timeFrame: the immediate post-intervention
measure: Acceptability of the intervention
timeFrame: the immediate post-intervention
measure: Change of fear of cancer recurrence
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Secondary outcomes:
measure: Change of quality of life
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
measure: Change of general psychological distress
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
measure: Attitude towards internet assessed using categorical Likert scales
timeFrame: the immediate post-intervention
measure: Treatment satisfaction
timeFrame: the immediate post-intervention
measure: Change of metacognition
timeFrame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Other outcomes:
Locations:
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: Danielle Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: