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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

E-intervention on Subclinical Fear of Cancer Recurrence

NCT06207006

Cancer Psychooncology Fear of Cancer Recurrence

RECRUITING NA

The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence

NCT04568226

Fear of Cancer Recurrence

COMPLETED NA

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

NCT05679518

Advanced or Metastatic Cancer Fear of Cancer Progression Metacognition-based Intervention +2 more

RECRUITING NA

A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

NCT05534386

Physical Symptom Distress Weight Management Neoplasms

RECRUITING NA

ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

NCT04137575

Fear of Cancer Recurrence Breast Cancer Female

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The current SMART trial aims to address the following hypotheses:

Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance.

Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, face-to-face ConquerFear than to augment eConquerFear with eHealthMaintenance.

Hypothesis 3: eConquerFear + ConquerFear will lead to the greatest reduction in fear of cancer recurrence.

Hypothesis 4: There would be an indirect effect of stepped-care ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition and cognitive attentional syndrome.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Fear of Cancer Recurrence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

First stage intervention: eConquerFear

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.

Group Type EXPERIMENTAL

eConquerFear

Intervention Type 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: eHealthMaintenance

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.

Group Type ACTIVE_COMPARATOR

eHealthMaintenance

Intervention Type 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.

Second stage intervention: ConquerFear-HK

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

Group Type EXPERIMENTAL

ConquerFear

Intervention Type BEHAVIORAL

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

Second stage intervention: eConquerFear+eHealthMaintenance

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.

Group Type ACTIVE_COMPARATOR

eConquerFear+eHealthMaintenance

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eConquerFear

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.

Intervention Type BEHAVIORAL

eHealthMaintenance

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.

Intervention Type BEHAVIORAL

ConquerFear

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

Intervention Type BEHAVIORAL

eConquerFear+eHealthMaintenance

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No