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Clinical Trial Summary

This phase III trial studies how well a telehealth self-management program works in improving survivorship care and outcomes in stage I-III non-small cell lung cancer or colorectal cancer survivors. Survivor self-management program focuses on coaching patients on follow-up care after cancer treatments. Participating in the program may improve knowledge and confidence about follow-up care, communication with cancer care and primary care doctors, and quality of life after cancer treatment in non-small cell lung cancer or colorectal cancer survivors.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine the efficacy of the intervention on care coordination, communication, and primary care provider (PCP) knowledge, comparing the intervention and attention control arms at 4 and 8 months post-accrual. II. Determine the efficacy of the intervention on survivor outcomes, comparing the intervention and attention control arms at 4 and 8 months post-accrual. EXPLORATORY OBJECTIVE: I. Assess the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the intervention. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (SURVIVOR SELF-MANAGEMENT): Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP. ARM II (ATTENTION CONTROL): Patients receive an American Society of Clinical Oncology (ASCO) care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to review a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP. After study initiation, patients are followed up at 4 and 8 months. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Lung Non-Small Cell Carcinoma
  • Stage I Colorectal Cancer AJCC v8
  • Stage I Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IB Lung Cancer AJCC v8
  • Stage II Colorectal Cancer AJCC v8
  • Stage II Lung Cancer AJCC v8
  • Stage IIA Colorectal Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Colorectal Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage IIC Colorectal Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8

NCT number NCT04428905
Study type Interventional
Source City of Hope Medical Center
Contact
Status Recruiting
Phase N/A
Start date July 11, 2020
Completion date March 31, 2025

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