The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence

NCT06181331 | Not Yet Recruiting

• 1 other identifier: FCR-SMART
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.

Conditions

Cancer; Fear of Cancer Recurrence

Keywords

Sequential multiple assessment randomized controlled trial; stepped-up care; psychooncology

Outcome Measures

Primary Outcomes (1)

• Change of fear of cancer recurrence (FCR)

  The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.

  baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention

Secondary Outcomes (2)

• Change of metacognitions

  baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention

• Change of cognitive attentional syndrome

  baseline (T0), one-month post-intervention (T1), and six-month (T2) post intervention

Study Arms (4)

First stage intervention: eConquerFear

EXPERIMENTAL

Participants in the eConquerFear 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

First stage intervention: eHealthMaintenance

ACTIVE COMPARATOR

Participants in the eHealthMaintenance 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: eHealthMaintenance

Second stage intervention: ConquerFear-HK

EXPERIMENTAL

ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks.

Behavioral: ConquerFear

Second stage intervention: eConquerFear+eHealthMaintenance

ACTIVE COMPARATOR

The augmented eConquerFear + eHealthMaintenance intervention is a combined unsupervised, self-guided web-based intervention that consists of 10 weekly online modules covering the content of eConquerFear and eHealthMaintenance interventions.

Behavioral: eConquerFear+eHealthMaintenance

Interventions

eConquerFear BEHAVIORAL

The key goals of this e-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.

First stage intervention: eConquerFear

eHealthMaintenance BEHAVIORAL

eHealthMaintenance 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.

First stage intervention: eHealthMaintenance

ConquerFear BEHAVIORAL

ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.

Second stage intervention: ConquerFear-HK

eConquerFear+eHealthMaintenance BEHAVIORAL

The combination of eConquerFear and eHealthMaintenance interventions, that consists of 10 weekly online modules.

Second stage intervention: eConquerFear+eHealthMaintenance

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 patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.

You may not qualify if:

• Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

QMh department of surgery

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wendy Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Ng, PhD

CONTACT

+852 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: he investigator, care provider, investigator 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 intervention or control arms. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the eConquerFear or eHealthMaintenance Second stage intervention for non-respondents: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the augment eConquerFear with eHealthMaintenance (or vice versa) versus switch to supervised, face-to-face ConquerFear intervention.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-03

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)