Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer

Not Applicable

Active, not recruiting

• Conditions: Stage I Colorectal Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survivorship Care Plan; Other: Telemedicine

• Registration Number: NCT04428905
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-07-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-06-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 403

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (personalized care plan, telehealth sessions)	Questionnaire Administration	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 (ASCO care plan, telehealth sessions)	Quality-of-Life Assessment	Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on 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.
Arm I (personalized care plan, telehealth sessions)	Survivorship Care Plan	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 (ASCO care plan, telehealth sessions)	Questionnaire Administration	Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on 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.
Arm I (personalized care plan, telehealth sessions)	Quality-of-Life Assessment	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 (ASCO care plan, telehealth sessions)	Telemedicine	Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on 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.
Arm I (personalized care plan, telehealth sessions)	Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
Survivor outcomes	At 8 months	Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 8 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.; Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better
Patient-centered communication	At 8 months	To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.; Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better
Care coordination	At 8 months	To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 8 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.; Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.
Oncologist/primary care providers (PCP) communication	At 8 months	To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 8 months (within group).; Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
PCP knowledge in survivorship care	At 8 months	To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.; Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
Quality of life: survey	At 8 months	A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.; Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States