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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-11

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors

NCT03063918

Cancer Survivor Stage I Rectosigmoid Cancer Stage II Rectosigmoid Cancer +1 more

COMPLETED NA

Supportive Clinic for Patients Living With Advanced and Metastatic Cancers

NCT06465511

Cancer Physical Symptom Distress

NOT_YET_RECRUITING NA

Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

NCT03958435

Stage II Colon Cancer Stage III Colon Cancer Adjuvant Therapy

UNKNOWN

Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment

NCT03516942

Stage I Colon Cancer AJCC v8 Stage I Rectal Cancer AJCC v8 Stage II Colon Cancer AJCC v8 +15 more

ACTIVE_NOT_RECRUITING

The Continuing Care Needs in Colorectal Cancer Patients in Different Stages

NCT00961129

Colorectal Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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