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Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277235
Recruitment Status : Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Behavioral: Resilience model-based total care plan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Behavioral: 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

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Self-report Questionnaire [ Time Frame: Change from baseline symptom at 12 months ]
    The questionnaire includes 24 items to assess symptom severity


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Self-report Questionnaire [ Time Frame: Change from baseline quality of life at 12 months ]
    The questionnaire includes 7 items to assess quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with stage I to III colon cancer.

Exclusion Criteria:

  • patients with cancer other than colon cancer or have cancer recurrence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277235


Contacts
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Contact: Shiow-Ching Shun, PHD 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Not yet recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, PHD    86-2-2312-3456 ext 88439    scshun@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Shiow-Ching Shun, PHD National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03277235     History of Changes
Other Study ID Numbers: 201612224RIND
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
fatigue
colon cancer
quality of life
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases