E-intervention on Subclinical Fear of Cancer Recurrence

NCT06207006 | Recruiting

• 1 other identifier: UW22-602
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Psychooncology; Fear of Cancer Recurrence

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Change of quality of life

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

• Change of general psychological distress

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

• Attitude towards internet assessed using categorical Likert scales

  the immediate post-intervention

• Treatment satisfaction

  the immediate post-intervention

• Change of metacognition

  Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention

Study Arms (2)

eConquerFear-HK

EXPERIMENTAL

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

Basic Cancer Care

ACTIVE COMPARATOR

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

Interventions

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.

eConquerFear-HK

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.

Basic Cancer Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Danielle Ng, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Ng, PhD

CONTACT

39179897; dwlng@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 16, 2024
• Study Start: May 2, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (1)