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Completed

NCT Number: NCT03277235

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

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.

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Key information

Conditions

Colorectal Cancer (MSI-H) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resilience model-based total care plan

Behavioral

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

Standard Care (in control arm)

Behavioral

standard care

Primary outcomes

  1. Resilience scale

    Time frame: Change from baseline resilience at 12 months

    The questionnaire includes 25 items to assess levels of resilience

Secondary outcomes

  1. Symptom Severity Scale

    Time frame: Change from baseline symptom at 12 months

    The questionnaire includes 24 items to assess symptom severity

  2. Fatigue Symptom Inventory

    Time frame: Change from baseline fatigue at 12 months

    The questionnaire includes 14 items to assess fatigue

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 11, 2017
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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