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CompletedNCT03277235Updated Aug 17, 2025

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

An interventional study of Resilience model-based total care plan and Standard Care (in control arm) in Colorectal Cancer (MSI-H), sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer (MSI-H)

Keywords

  • resilience
  • cancer prehabilitation
  • physical distress
  • psychological distress
  • spiritual well-being
  • colorectal cancer
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
128 participants (actual)

Study arms

  • 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

  • Other
    Control

    standard care

    Behavioral: Standard Care (in control arm)

Interventions

  • BehavioralResilience 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

  • BehavioralStandard Care (in control arm)

    standard care

05

What researchers measure

Primary outcomes

  1. Resilience scale

    The questionnaire includes 25 items to assess levels of resilience

    Time frame: Change from baseline resilience at 12 months

Secondary outcomes

  1. Symptom Severity Scale

    The questionnaire includes 24 items to assess symptom severity

    Time frame: Change from baseline symptom at 12 months

  2. Fatigue Symptom Inventory

    The questionnaire includes 14 items to assess fatigue

    Time frame: Change from baseline fatigue at 12 months

  3. Center for Epidemiological Studies Depression Scale

    The questionnaire includes 20 items to assess depressive symptoms

    Time frame: Change from baseline depressive symptoms at 12 months

  4. Fear of Cancer Recurrence Inventory-Short Form

    The questionnaire includes 9 items to assess fear of cancer recurrence

    Time frame: Change from baseline fear of cancer recurrence at 12 months

  5. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale

    The questionnaire includes 12 items to assess spiritual well-being

    Time frame: Change from baseline spiritual well-being at 12 months

06

Study locations

1 site
  • National Taiwan University
    Taipei, Taiwan
07

References and documents

Publications

  • Chou YJ, Lee YH, Lin BR, Jiang JK, Yang HY, Lin HY, Shun SC. Serial multiple mediation model of fear of cancer recurrence in patients with colorectal cancer. Health Psychol. 2025 Oct;44(10):955-962. doi: 10.1037/hea0001483. Epub 2025 Apr 14. PubMed 40232818 ↗
  • Liao YT, Chou YJ, Wu CT, Liu YH, Liang JT, Lai F, Shun SC. Wearable mobile health device for monitoring postoperative ambulation among patients with colorectal cancer undergoing minimally invasive surgery: A prospective comparison study. Int J Med Robot. 2024 Apr;20(2):e2626. doi: 10.1002/rcs.2626. PubMed 38517612 ↗
  • Chou YJ, Lin HY, Cooper BA, Lin BR, Jiang JK, Yang HY, Miaskowski C, Shun SC. A Resilience Model for Patients With Colorectal Cancer: A Structural Equation Modeling Analysis. Cancer Nurs. 2022 Jan-Feb 01;45(1):E83-E90. doi: 10.1097/NCC.0000000000000882. PubMed 34870940 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03277235
Lead sponsor
National Taiwan University Hospital
Collaborators
National Science and Technology Council, Taiwan
Responsible party
Sponsor
First posted
Sep 11, 2017
Start date
Oct 1, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023
Last update
Aug 17, 2025

Study contacts

Shiow-Ching Shun, PHD
study chair · National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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