- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277235
Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients
September 7, 2017 updated by: National Taiwan University Hospital
Effect of a Resilience Model-Based Care Plan in Reducing Fear of Recurrence and GI Symptom Distress and Improving Quality of Life in Newly Diagnosed Colorectal Cancer Patients
The aims of this three-year study are to explore the protective and risk factors of resilience in colorectal cancer patients, and examine the effect of the resilience model-based care plan in reducing fear of recurrence and GI symptom distress and improving quality of life in newly diagnosed colorectal cancer (CRC) patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Develop and evaluate the effect of a resilience model-based total care plan on reducing fear of recurrence and GI symptom distress and improving quality of life (QOL) in this population.
Study Type
Interventional
Enrollment (Anticipated)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with stage I to III colon cancer.
Exclusion Criteria:
- patients with cancer other than colon cancer or have cancer recurrence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual care
|
|
Experimental: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report Questionnaire
Time Frame: Change from baseline symptom at 12 months
|
The questionnaire includes 24 items to assess symptom severity
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Change from baseline symptom at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report Questionnaire
Time Frame: Change from baseline fear of cancer recurrence at 12 months
|
The questionnaire includes 42 items to assess fear of cancer recurrence
|
Change from baseline fear of cancer recurrence at 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report Questionnaire
Time Frame: Change from baseline quality of life at 12 months
|
The questionnaire includes 7 items to assess quality of life
|
Change from baseline quality of life at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2017
Primary Completion (Anticipated)
July 31, 2021
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
September 7, 2017
First Submitted That Met QC Criteria
September 7, 2017
First Posted (Actual)
September 11, 2017
Study Record Updates
Last Update Posted (Actual)
September 11, 2017
Last Update Submitted That Met QC Criteria
September 7, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612224RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colon Cancer
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National Cancer Institute (NCI)NSABP Foundation IncCompletedColon Adenocarcinoma | Stage IIIA Colon Cancer AJCC v7 | Stage IIIB Colon Cancer AJCC v7 | Stage IIIC Colon Cancer AJCC v7 | Stage IIA Colon Cancer AJCC v7 | Stage IIB Colon Cancer AJCC v7 | Stage IIC Colon Cancer AJCC v7United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineRecruitingStage II Colon Cancer | Stage III Colon Cancer | HER2-positive Colon Cancer | RAS Wild-type Colon CancerItaly
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Depressive Symptoms | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Psychosocial Effects of Cancer and Its Treatment | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage I Colon Cancer | Stage... and other conditionsUnited States
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingStage III Colon Cancer AJCC v8 | Colon Adenocarcinoma | Microsatellite Stable Colon Carcinoma | Stage IIB Colon Cancer AJCC v8 | Stage IIC Colon Cancer AJCC v8United States
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Hospital da Senhora da OliveiraCompletedColon Cancer | Colon Adenoma | Colon Polyp | Colon Rectal CancerPortugal
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National Cancer Institute (NCI)CompletedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal CancerUnited States
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Howard S. Hochster, MDRecruitingStage IV Colon Cancer AJCC v8 | Stage IVA Colon Cancer AJCC v8 | Stage IVB Colon Cancer AJCC v8 | Stage IVC Colon Cancer AJCC v8 | Metastatic Colon CarcinomaUnited States
-
NorgineXolomon Tree S.L.CompletedColon Cancer | Colon Disease | Colon CleansingSpain, Portugal
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