Effect of a Resilience Model-Based Program for Patients With Newly Diagnosed Colorectal Cancer

August 13, 2025 updated by: National Taiwan University Hospital

Effectiveness of a Resilience Model-Based Cancer Prehabilitation Program for Patients With Newly Diagnosed Colorectal Cancer: A Randomized Controlled Trial

To develop a resilience model-based cancer prehabilitation program and evaluate its efficacy in improving resilience, alleviating symptoms, and enhancing spiritual well-being in patients with newly diagnosed colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Develop and evaluate the effect of a resilience model-based total care plan on reducing fear of recurrence and GI symptom distress, resilience and improving spiritual well-being in this population.

Study Type

Interventional

Enrollment (Actual)

128

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 Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The inclusion criteria were as follows: being aged ≧ 20 years, receiving a new diagnosis of stage 0-III colorectal cancer and being scheduled to undergo surgery, being aware of the diagnosis, being able to communicate in Mandarin or Taiwanese, and providing written informed consent. The exclusion criteria were as follows: receiving a diagnosis of stage IV colorectal cancer, having recurrent colorectal cancer or multiple cancers, and having a history of psychiatric disorders.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resilience model-based cancer prehabilitation program plus standard care
12-week care plan with 5 in-person and 12 remote sessions, including both physical and psychological components.
Behavioral: Resilience model-based total care plan
12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience
Other: Control
standard care
Behavioral: Standard Care (in control arm)
standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resilience scale
Time Frame: Change from baseline resilience at 12 months
The questionnaire includes 25 items to assess levels of resilience
Change from baseline resilience at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Symptom Inventory
Time Frame: Change from baseline fatigue at 12 months
The questionnaire includes 14 items to assess fatigue
Change from baseline fatigue at 12 months
Center for Epidemiological Studies Depression Scale
Time Frame: Change from baseline depressive symptoms at 12 months
The questionnaire includes 20 items to assess depressive symptoms
Change from baseline depressive symptoms at 12 months
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale
Time Frame: Change from baseline spiritual well-being at 12 months
The questionnaire includes 12 items to assess spiritual well-being
Change from baseline spiritual well-being at 12 months
Symptom Severity Scale
Time Frame: Change from baseline symptom at 12 months
The questionnaire includes 24 items to assess symptom severity
Change from baseline symptom at 12 months
Fear of Cancer Recurrence Inventory-Short Form
Time Frame: Change from baseline fear of cancer recurrence at 12 months
The questionnaire includes 9 items to assess fear of cancer recurrence
Change from baseline fear of cancer recurrence at 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Questionnaire
Time Frame: Change from baseline quality of life at 12 months
The questionnaire includes 7 items to assess quality of life
Change from baseline quality of life at 12 months

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Collaborators

National Science and Technology Council, Taiwan

Investigators

  • Study Chair: Shiow-Ching Shun, PHD, National Taiwan University

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 (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201612224RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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