Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage IB Lung Cancer AJCC v8
- Lung Non-Small Cell Carcinoma
- Stage IIB Lung Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- 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 III Lung Cancer AJCC v8
- Stage IIB Colorectal Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage II Colorectal Cancer AJCC v8
- Stage IIIA Colorectal Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIA Colorectal Cancer AJCC v8
- Stage IIIC Colorectal Cancer AJCC v8
- Stage IIC Colorectal Cancer AJCC v8
- Stage IIIB Colorectal Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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,...
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.
Tracking Information
- NCT #
- NCT04428905
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Virginia Sun City of Hope Medical Center