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

NCT ID: NCT03277235

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer (MSI-H)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Resilience model-based total care plan

Intervention Type 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

Control

standard care

Group Type OTHER

Standard Care (in control arm)

Intervention Type BEHAVIORAL

standard care

Interventions

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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

Intervention Type BEHAVIORAL

Standard Care (in control arm)

standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shiow-Ching Shun, PHD

Role: STUDY_CHAIR

National Taiwan University

Locations

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National Taiwan University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 40232818 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38517612 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34870940 (View on PubMed)

Other Identifiers

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201612224RIND

Identifier Type: -

Identifier Source: org_study_id

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