Trials / Active Not Recruiting
Active Not RecruitingNCT04428905
Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer
Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancers
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 403 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
| OTHER | Survivorship Care Plan | Receive personalized care plan/resource manual |
| OTHER | Telemedicine | Participate in telehealth sessions |
Timeline
- Start date
- 2020-07-11
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2020-06-11
- Last updated
- 2026-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04428905. Inclusion in this directory is not an endorsement.