Self-Management Survivorship Care for Lung and Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 7 months

403 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a self-management program for cancer survivors, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Self-Management Survivorship Care, Telemedicine, Telehealth, Virtual Care, Remote Healthcare, E-Health for lung and colorectal cancer?

Research shows that self-management interventions can help cancer survivors improve their health and well-being by teaching them how to manage the after-effects of treatment. These programs have been effective in other types of cancer, like breast cancer, and are based on behavior change theories that help patients cope better with their condition. ^{1 2 3 4 5}

Is Self-Management Survivorship Care safe for humans?

The available research does not specifically address safety concerns for Self-Management Survivorship Care, but it is generally designed to support cancer survivors in managing their health post-treatment, suggesting it is considered safe for use in humans. ^{1 2 3 6 7}

How is the Self-Management Survivorship Care treatment different from other treatments for lung and colorectal cancer?

The Self-Management Survivorship Care treatment is unique because it focuses on empowering cancer survivors to manage their own health after treatment, using a telehealth approach that combines self-management skills with coordinated care between oncology and primary care teams. This approach is designed to address the specific post-treatment needs of survivors, which are often not fully met by standard follow-up care plans. ^{1 2 3 6 8}

What is the purpose of this trial?

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.

Research Team

Virginia Sun, RN

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for stage I-III non-small cell lung or colorectal cancer survivors who finished treatment at least 4 months ago. Participants must understand English and be willing to consent to the study's requirements. Those unable to comply with the study as judged by the investigator cannot join.

Inclusion Criteria

My cancer was initially stage I, II, or III.

I finished treatment for NSCLC or colorectal cancer over 4 months ago.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized care plan and participate in telehealth sessions for self-management skills building

7 months

8 telehealth sessions (5 sessions over 4 months, 3 sessions over 3 months)

Follow-up

Participants are monitored for outcomes such as care coordination, communication, and quality of life

8 months

Treatment Details

Interventions

• Self-Management Survivorship Care
• Telemedicine

Trial Overview The trial examines a telehealth self-management program aimed at improving survivorship care for cancer survivors. It includes coaching on follow-up care, using tools like telemedicine, survivorship care plans, questionnaires, and quality-of-life assessments.

Participant Groups

Group I: Arm I (personalized care plan, telehealth sessions) Experimental Treatment 4 Interventions

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.

Group II: Arm II (ASCO care plan, telehealth sessions) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Survivors of lung and colorectal cancer often face significant post-treatment challenges, including poor quality of life and greater health complications, yet they are underrepresented in research, leading to disparities in care.

This study outlines a new telehealth intervention designed to enhance care coordination between oncology and primary care, aiming to empower cancer survivors through self-management skills and improve their post-treatment outcomes, which will be tested in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer. Sun, V., Reb, A., Debay, M., et al.[2023]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Empowering survivors after colorectal and lung cancer treatment: Pilot study of a Self-Management Survivorship Care Planning intervention. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Meeting the challenge of cancer survivorship in public health: results from the evaluation of the chronic disease self-management program for cancer survivors. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

An Integrative Review of Self-Management Interventions for Treatment Sequelae in Adult Survivors. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness and components of self-management interventions in adult cancer survivors: a protocol for a systematic review and planned meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient self-management programme for breast cancer as a chronic illness: a non-randomised controlled clinical trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Receipt of a survivorship care plan and self-reported health behaviors among cancer survivors. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Is self-management feasible and acceptable for addressing nutrition and physical activity needs of cancer survivors? [2018]