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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Resilience model-based total care plan
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring fatigue, colon cancer, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with stage I to III colon cancer.

Exclusion Criteria:

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

Sites / Locations

  • National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resilience model-based total care plan

Control

Arm Description

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

Usual care

Outcomes

Primary Outcome Measures

Self-report Questionnaire
The questionnaire includes 24 items to assess symptom severity

Secondary Outcome Measures

Self-report Questionnaire
The questionnaire includes 42 items to assess fear of cancer recurrence

Full Information

First Posted
September 7, 2017
Last Updated
September 7, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03277235
Brief Title
Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
fatigue, colon cancer, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resilience model-based total care plan
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Resilience model-based total care plan
Intervention Description
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
Primary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 24 items to assess symptom severity
Time Frame
Change from baseline symptom at 12 months
Secondary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 42 items to assess fear of cancer recurrence
Time Frame
Change from baseline fear of cancer recurrence at 12 months
Other Pre-specified Outcome Measures:
Title
Self-report Questionnaire
Description
The questionnaire includes 7 items to assess quality of life
Time Frame
Change from baseline quality of life at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with stage I to III colon cancer. Exclusion Criteria: patients with cancer other than colon cancer or have cancer recurrence.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ching Shun, PHD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Phone
86-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34870940
Citation
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.
Results Reference
derived

Learn more about this trial

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

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