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NCT Number: NCT06207006

E-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital-Department of Surgery

Hong Kong

Location status: Recruiting

Location contact

Dominic Foo

CONTACT

[email protected]

About this study

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:

  • There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
  • There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
  • 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.
  • Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention.
  • Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eConquerFear-HK

Behavioral

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.

Basic Cancer Care

Behavioral

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.

Primary outcomes

  1. Rate of subject recruitment

    Time frame: baseline

    number of participants consent and being randomized/number of eligible patients x 100

  2. Rate of subject retention

    Time frame: baseline,3-months post-intervention and 6-months post-intervention

    number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100

  3. Adherence rate to intervention

    Time frame: the immediate post-intervention

    number of participants who complete the intervention/number of being allocated to attend the intervention x 100

  4. Intervention utility

    Time frame: the immediate post-intervention

    Intervention utility will be assessed using the site use metrics, including total number of log-ins

  5. Acceptability of the intervention

    Time frame: the immediate post-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.

  6. Change of fear of cancer recurrence

    Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

    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.

Secondary outcomes

  1. Change of quality of life

    Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

    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).

  2. Change of general psychological distress

    Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

    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.

  3. Attitude towards internet assessed using categorical Likert scales

    Time frame: the immediate post-intervention

    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.

  4. Treatment satisfaction

    Time frame: the immediate post-intervention

    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.

  5. Change of metacognition

    Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Ng, PhD

CONTACT

[email protected]

39179897

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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