Cancer Survivors' Fear of Cancer Recurrence (MHPII)

April 14, 2026 updated by: Shiuyu Katie Lee,RN MSN PhD, National Taipei University of Nursing and Health Sciences

Development and Evaluation of An Innovative Program in Mental Health Promotion

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".

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: education group
one session of nurses' education and information
Behavioral: education
FCR education
Experimental: ConquerFear group
a 6-session add-on psychological cognitive training performed by a trained psychologist
Behavioral: education
FCR education
Behavioral: psycological cognitive training
Metacognition
Other Names:
  • ConquerFear
Experimental: Healthy lifestyle group
a 6-session add-on individualized nutrition and exercise guidance performed by a trained nutritionist and an exercise expert.
Behavioral: education
FCR education
Behavioral: Healthy lifestyle
individualized nutrition and exercise guidance
Other Names:
  • nutrition counseling
  • excercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Cance Recurrence
Time Frame: From the baseline to the 3 months after intervention at 5 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress
Time Frame: From the baseline to the 3 months after intervention at 5 months
the change of the anxiety and depression as measured by HADS
From the baseline to the 3 months after intervention at 5 months
QOL
Time Frame: From the baseline to the 3 months after intervention at 5 months
The change of the quality of life score as measured by VR-12
From the baseline to the 3 months after intervention at 5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metacognition
Time Frame: From the baseline to the 3 month after intervention at 5 months
the change of metacognition as measured by MCQ-30
From the baseline to the 3 month after intervention at 5 months
Intervention Satisfaction
Time Frame: at the end of intervention at 2 month
the score of self-designed satisfaction score with the intervention
at the end of intervention at 2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Koo Foundation Sun Yat-Sen Cancer Center
Ministry of Health and Welfare, Taiwan

Investigators

  • Principal Investigator: Shiuyu C. Katie Lee, PhD, National Taipei University of Nursing and Health Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTUNHS114G010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is restricted by the sponsors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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