Colorectal Cancer (MSI-H)NCT03277235
Effect of a Resilience Model-Based Program for Patients With Newly Diagnosed Colorectal Cancer
A study testing Resilience model-based total care plan in people with Colorectal Cancer (MSI-H), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H)
- What is being tested?
- Resilience model-based total care plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Resilience Model-Based Cancer Prehabilitation Program for Patients With Newly Diagnosed Colorectal Cancer: A Randomized Controlled Trial
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.
- Conditions
- Colorectal Cancer (MSI-H)
- Being tested
- Resilience model-based total care plan, Standard Care (in control arm)
- Keywords
- resilience, cancer prehabilitation, physical distress, psychological distress, spiritual well-being, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience model-based total care planBehavioural
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)Behavioural
standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resilience model-based total care plan |
| Control | Other | standard care Receives: Behavioral: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience scale
The questionnaire includes 25 items to assess levels of resilience
Measured: Change from baseline resilience at 12 months
Secondary outcomes (5)
Symptom Severity Scale
The questionnaire includes 24 items to assess symptom severity
Measured: Change from baseline symptom at 12 months
Fatigue Symptom Inventory
The questionnaire includes 14 items to assess fatigue
Measured: Change from baseline fatigue at 12 months
Center for Epidemiological Studies Depression Scale
The questionnaire includes 20 items to assess depressive symptoms
Measured: Change from baseline depressive symptoms at 12 months
Fear of Cancer Recurrence Inventory-Short Form
The questionnaire includes 9 items to assess fear of cancer recurrence
Measured: Change from baseline fear of cancer recurrence at 12 months
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale
The questionnaire includes 12 items to assess spiritual well-being
Measured: Change from baseline spiritual well-being at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Oct 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shiow-Ching Shun, PHD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277235
- Sponsor's protocol ID
- 201612224RIND
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 40232818Liao 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 38517612Chou 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Resilience Model-Based Cancer Prehabilitation Program for Patients With Newly Diagnosed Colorectal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03277235
- Acronym / sponsor ID
- 201612224RIND
- Conditions
- Colorectal Cancer (MSI-H)
- Keywords
- resilience, cancer prehabilitation, physical distress, psychological distress, spiritual well-being, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience model-based cancer prehabilitation program plus standard care | Experimental | Behavioral: Resilience model-based total care plan12-week care plan with 5 in-person and 12 remote sessions, including both physical and psychological components. |
| Control | Other | Behavioral: Standard Care (in control arm)standard care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience model-based total care plan12-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 | Behavioural | Resilience model-based cancer prehabilitation program plus standard care |
| Standard Care (in control arm)standard care | Behavioural | Control |
Primary outcome
Resilience scale
Time frame: Change from baseline resilience at 12 months
The questionnaire includes 25 items to assess levels of resilience
5 secondary outcomes
Symptom Severity Scale
Time frame: Change from baseline symptom at 12 months
Fatigue Symptom Inventory
Time frame: Change from baseline fatigue at 12 months
Center for Epidemiological Studies Depression Scale
Time frame: Change from baseline depressive symptoms at 12 months
Fear of Cancer Recurrence Inventory-Short Form
Time frame: Change from baseline fear of cancer recurrence at 12 months
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale
Time frame: Change from baseline spiritual well-being at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 40232818Chou 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.
- Derived from this study: PubMed 38517612Liao 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.
- Derived from this study: PubMed 34870940Chou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiow-Ching Shun, PHD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience model-based total care plan in people with Colorectal Cancer (MSI-H), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience scale (time frame: Change from baseline resilience at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.