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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03277235
• Other study ID #: 201612224RIND
• Status: Not yet recruiting
• Phase: N/A
• First received: September 7, 2017
• Last updated: September 7, 2017
• Start date: September 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2017
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, PHD
• Phone: 886-2-23123456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients with stage I to III colon cancer.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-report Questionnaire	The questionnaire includes 7 items to assess quality of life	Change from baseline quality of life at 12 months
Primary	Self-report Questionnaire	The questionnaire includes 24 items to assess symptom severity	Change from baseline symptom at 12 months
Secondary	Self-report Questionnaire	The questionnaire includes 42 items to assess fear of cancer recurrence	Change from baseline fear of cancer recurrence at 12 months