E-intervention on Subclinical Fear of Cancer Recurrence

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Fear of Cancer Recurrence; Psychooncology
• Intervention / Treatment: Behavioral: eConquerFear-HK; Behavioral: Basic Cancer Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Ng, PhD; Phone Number: 39179897; Email: dwlng@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eConquerFear-HK; Participants in the eConquerFear-HK intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention.	Behavioral: eConquerFear-HK; 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.
Active Comparator: Basic Cancer Care; Participants in the control group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term.	Behavioral: Basic Cancer Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of subject recruitment	number of participants consent and being randomized/number of eligible patients x 100	baseline
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	baseline,3-months post-intervention and 6-months post-intervention
Adherence rate to intervention	number of participants who complete the intervention/number of being allocated to attend the intervention x 100	the immediate post-intervention
Intervention utility	Intervention utility will be assessed using the site use metrics, including total number of log-ins	the immediate post-intervention
Acceptability of the intervention	Acceptability of the intervention will be assessed using the 22-item measure, which was adopted from the 31-item measure designed to assess the general views on the presentation and content of information in a decision aid intervention for treatment decision making. It assess the comprehensibility of the intervention content and also its utility using 4- (1 = "Poor"; 2 = "Fair"; 3 = "Good"; 4 = "Excellent") or 5-option (1 ="strongly disagree"; 5 = "strongly agree") categorical responses, respectively. Higher scores indicate better acceptability.	the immediate post-intervention
Change of fear of cancer recurrence	Fear of cancer recurrence. FCR will be assessed using the Chinese 42-item Fear of Cancer Recurrence Inventory (FCRI) at four assessment points (T0-T3).(5) FCRI comprises seven subscales: trigger, severity, psychological distress, functional impairment, reassurance, insights and coping strategies measured using 5-point Likert scales (0 = "never"; 4 = " a great deal or all the time").(5) Total scores range from 0 to 168; with higher scores indicating higher FCR.	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
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.	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
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.	the immediate post-intervention
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.	the immediate post-intervention
Change of metacognition	Metacognition will be assessed at T0-T3 using the 30-item Metacognitions Questionnaire- 30 (MCQ-30), consisting of five subscales assessing Positive beliefs about worry, Negative beliefs about worry, Cognitive Self-Consciousness, Cognitive Confidence, and Need to control thoughts. A 4 points-categorical Likert scale (1-4) will be used. Higher scores indicate worse metacognition	Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Danielle Ng, PhD, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: UW22-602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No