Clinical trial NCT04428905: Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer
Official title: Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-11
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer (NSCLC) and colorectal cancer survivors who are 4 months post-treatment completion
* History of stage I-III disease
* Ability to read or understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the principal investigator (PI), may not be able to comply with the requirements of the study

Primary outcomes:
measure: Care coordination
timeFrame: At Baseline
measure: Care coordination
timeFrame: At 4 months
measure: Care coordination
timeFrame: At 8 months
measure: Oncologist/primary care providers (PCP) communication
timeFrame: At Baseline
measure: Oncologist/primary care providers (PCP) communication
timeFrame: At 4 months
measure: Oncologist/primary care providers (PCP) communication
timeFrame: At 8 months
measure: PCP knowledge in survivorship care
timeFrame: At Baseline
measure: PCP knowledge in survivorship care
timeFrame: At 4 months
measure: PCP knowledge in survivorship care
timeFrame: At 8 months
measure: Survivor outcomes
timeFrame: At Baseline
measure: Survivor outcomes
timeFrame: At 4 months
measure: Survivor outcomes
timeFrame: At 8 months
measure: Patient-centered communication
timeFrame: At Baseline
measure: Patient-centered communication
timeFrame: At 4 months
measure: Patient-centered communication
timeFrame: At 8 months
measure: Quality of life: survey
timeFrame: At Baseline
measure: Quality of life: survey
timeFrame: At 4 months
measure: Quality of life: survey
timeFrame: At 8 months
Secondary outcomes:
Other outcomes:
measure: Overall reach (participation rate) with primary care providers (Arm I)
timeFrame: Up to 8 months
measure: Percentage of primary care providers who received a clinical care plan (Arm I)
timeFrame: Up to 8 months
measure: Primary care providers' use of care plan information for survivorship care (Arm I)
timeFrame: Up to 8 months
measure: Potential barriers and facilitators for intervention implementation and maintenance
timeFrame: Up to 8 months
measure: Outcome Measure for facilitators
timeFrame: Up to 8 months
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun V, Reb A, Debay M, Fakih M, Ferrell B. Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer. J Cancer Educ. 2021 Apr;36(2):414-420. doi: 10.1007/s13187-021-01958-8. Epub 2021 Jan 8.