E-intervention on Subclinical Fear of Cancer Recurrence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
eConquerFear-HK
BehavioralThe 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.
Basic Cancer Care
BehavioralBasic 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: eConquerFear-HKExperimental treatment 1 intervention
Group B: Basic Cancer CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of subject recruitment
number of participants consent and being randomized/number of eligible patients x 100
Time frame
baseline2
Rate of subject retention
number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100
Time frame
baseline,3-months post-intervention and 6-months post-intervention3
Adherence rate to intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Time frame
the immediate post-intervention4
Intervention utility
Intervention utility will be assessed using the site use metrics, including total number of log-ins
Time frame
the immediate post-interventionSecondary outcomes
1
Change of quality of life
Quality of life will be measured by the Chinese version of the 30-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), consisting of five functional subscales (physical, role, emotional, cognitive, and social functioning), three symptom subscales (pain, fatigue and nausea/vomiting), a global health subscale, five single symptom items (e.g., sleep disturbance, dyspnea, appetite loss, constipation, and diarrhea), and an single item for financial difficulty. The score range is 0-100. High scores on the functional and global health subscales indicate better functioning and QoL, respectively. High scores on the symptom subscale or item indicate more symptom(s).
Time frame
Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention2
Change of general psychological distress
e Chinese 14-item Hospital Anxiety and Depression Scale (HADS),(21) comprising two 7-item subscales that measure anxiety and depression. Each subscale total scores range from 0 to 21 with higher scores suggesting higher distress.
Time frame
Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention3
Attitude towards internet assessed using categorical Likert scales
Attitude towards internet will be assessed using a 6 points-categorical Likert scale (0-5) asking if they find internet easy to use. Higher scores indicate more positive attitude towards internet.
Time frame
the immediate post-intervention4
Treatment satisfaction
A 17-item treatment satisfaction questionnaire, originally designed to evaluate overall satisfaction with the intervention in our current RCT of ConquerFear-HK, will be used. The first 9 items will be assessed using a 5 points-categorical Likert scale (1-5) Higher scores indicate higher satisfaction. The remaining questions are open-questions.
Time frame
the immediate post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov