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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03277235
Enrollment
128
Registered
2017-09-11
Start date
2018-10-01
Completion date
2023-12-31
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer (MSI-H)

Keywords

resilience, cancer prehabilitation, physical distress, psychological distress, spiritual well-being, colorectal cancer

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.

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.

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

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Resilience scaleChange from baseline resilience at 12 monthsThe questionnaire includes 25 items to assess levels of resilience

Secondary

MeasureTime frameDescription
Symptom Severity ScaleChange from baseline symptom at 12 monthsThe questionnaire includes 24 items to assess symptom severity
Fatigue Symptom InventoryChange from baseline fatigue at 12 monthsThe questionnaire includes 14 items to assess fatigue
Center for Epidemiological Studies Depression ScaleChange from baseline depressive symptoms at 12 monthsThe questionnaire includes 20 items to assess depressive symptoms
Fear of Cancer Recurrence Inventory-Short FormChange from baseline fear of cancer recurrence at 12 monthsThe questionnaire includes 9 items to assess fear of cancer recurrence
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being ScaleChange from baseline spiritual well-being at 12 monthsThe questionnaire includes 12 items to assess spiritual well-being

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026