NCT03277235

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 17, 2025

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

September 7, 2017

Last Update Submit

August 13, 2025

Conditions

Colorectal Cancer (MSI-H)

Keywords

resiliencecancer prehabilitationphysical distresspsychological distressspiritual well-beingcolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Resilience scale

    The questionnaire includes 25 items to assess levels of resilience

    Change from baseline resilience at 12 months

Secondary Outcomes (5)

  • Symptom Severity Scale

    Change from baseline symptom at 12 months

  • Fatigue Symptom Inventory

    Change from baseline fatigue at 12 months

  • Center for Epidemiological Studies Depression Scale

    Change from baseline depressive symptoms at 12 months

  • Fear of Cancer Recurrence Inventory-Short Form

    Change from baseline fear of cancer recurrence at 12 months

  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale

    Change from baseline spiritual well-being at 12 months

Study Arms (2)

Resilience model-based cancer prehabilitation program plus standard care

EXPERIMENTAL

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

Control

OTHER

standard care

Behavioral: Standard Care (in control arm)

Interventions

Resilience model-based total care planBEHAVIORAL

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

Resilience model-based cancer prehabilitation program plus standard care
Standard Care (in control arm)BEHAVIORAL

standard care

Control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 40232818DERIVED

  • 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.

    PMID: 38517612DERIVED

  • 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.

    PMID: 34870940DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Shiow-Ching Shun, PHD

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 11, 2017

Study Start

October 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 17, 2025

Record last verified: 2017-09

Locations

TW(1)