NCT07542821

Brief Summary

The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

April 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Fear of Cacer Recurrence in Cancer Survivorws

Keywords

Fear of cancer recurrencecancer survivorpsychosoical supportConquerFearHealthy life style

Outcome Measures

Primary Outcomes (1)

  • Fear of Cance Recurrence

    the change of FCR (Fear of Cancer Recurrence) score as measured by FCRI

    From the baseline to the 3 months after intervention at 5 months

Secondary Outcomes (2)

  • Psychological distress

    From the baseline to the 3 months after intervention at 5 months

  • QOL

    From the baseline to the 3 months after intervention at 5 months

Other Outcomes (2)

  • Metacognition

    From the baseline to the 3 month after intervention at 5 months

  • Intervention Satisfaction

    at the end of intervention at 2 month

Study Arms (3)

education group

ACTIVE COMPARATOR

one session of nurses' education and information

Behavioral: education

ConquerFear group

EXPERIMENTAL

a 6-session add-on psychological cognitive training performed by a trained psychologist

Behavioral: psycological cognitive trainingBehavioral: education

Healthy lifestyle group

EXPERIMENTAL

a 6-session add-on individualized nutrition and exercise guidance performed by a trained nutritionist and an exercise expert.

Behavioral: Healthy lifestyleBehavioral: education

Interventions

psycological cognitive trainingBEHAVIORAL

Metacognition

Also known as: ConquerFear
ConquerFear group
Healthy lifestyleBEHAVIORAL

individualized nutrition and exercise guidance

Also known as: nutrition counseling, excercise training
Healthy lifestyle group
educationBEHAVIORAL

FCR education

ConquerFear groupHealthy lifestyle groupeducation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage I, II, III breast, head and neck, colo-rectal, proste cancer and completion of primary cancer treatment
  • report of fear of cancer recurrence
  • able to read and listen in Manderin and without a cognitive defect

You may not qualify if:

  • diagnosed with severe mental illness
  • difficult to communicate in Manderin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Park SY, Lim JW. Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature. BMC Cancer. 2022 Feb 28;22(1):217. doi: 10.1186/s12885-021-08909-y.

    PMID: 35227244BACKGROUND

  • Ng DWL, Ng R, Guo C, Chan J, Fielding R, Tang JWC, Li WWY, Foo CC, Kwong A, Ng SS, Suen D, Fung S, Chun OK, Chan KKL, Chang ATY, Butow P, Lam WWT. ConquerFear-HK: A Randomized Controlled Trial of a Metacognition-Based, Manualized Intervention for Fear of Cancer Recurrence among Chinese Cancer Survivors. Psychother Psychosom. 2025 Aug 8:1-17. doi: 10.1159/000547888. Online ahead of print.

    PMID: 40784346BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Shiuyu C. Katie Lee, PhD

    National Taipei University of Nursing and Health Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiuyu C. Katie Lee

CONTACT

886961395150shiuyu@ntunhs.edu.tw

Shiao-Wei Cheng

CONTACT

886919885149study1042@ntunhs.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Based on screening levels of fear of cancer recurrence (FCR), those with lower FCR will receive only education, and those with medium or higher FCR will be randomized to one of two add-on psychological cognitive training or individualized healthy lifestyle guidance groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

It is restricted by the sponsors.