Self-Management Survivorship Care for Lung and Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 3

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)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program designed to assist individuals who have completed treatment for stage I-III non-small cell lung cancer or colorectal cancer. The program aims to enhance knowledge and confidence about follow-up care through coaching sessions with a nurse. Participants will receive either a standard or personalized care plan and engage in telehealth sessions to develop self-management skills, which involve a self-guided approach to managing one's own health. Individuals who completed cancer treatment at least 4 months ago and understand English may be suitable candidates. The goal is to improve communication with doctors and enhance quality of life after treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking program.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that self-care programs for cancer survivors are generally well-received by patients. In studies with colorectal and lung cancer survivors, telehealth self-care programs proved easy to use and satisfactory, allowing participants to complete the program happily.

Regarding safety, the telehealth sessions, a main component of the program, have been proven safe and effective. Studies found no major safety concerns when comparing online care to traditional in-person visits, suggesting that the telehealth method used in the program is safe for participants.

Overall, earlier research suggests that the program is safe and manageable for most patients. Participants have not reported any major negative effects, making it a promising option for those seeking to improve their care after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how self-management survivorship care can improve life after cancer treatment for lung and colorectal cancer patients. Unlike traditional follow-up care, which often focuses on monitoring recurrence, this approach emphasizes empowering patients with skills to manage their health. The trial includes personalized care plans and telehealth sessions, offering tailored support and guidance directly to patients and involving their primary care physicians. This method could foster a more proactive and patient-centered approach, potentially leading to better overall well-being for survivors.

What evidence suggests that this trial's self-management survivorship care and telehealth sessions could be effective for lung and colorectal cancer survivors?

Research has shown that self-care programs can improve the lives of cancer survivors. In this trial, participants in Arm I will receive a personalized care plan and engage in telehealth sessions focused on building self-management skills. Participants in Arm II will receive an ASCO care plan and participate in telehealth sessions to discuss life after cancer treatment. Studies have found these programs to be practical and well-received by individuals who have completed treatment for colorectal and lung cancer. They help survivors feel more confident about their follow-up care and improve communication with their doctors. Additionally, using telehealth in these programs proves just as effective as in-person visits for enhancing quality of life. These methods can help cancer survivors manage their health better after treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Virginia Sun, RN

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04428905

Self-Management Survivorship Care in Stage I-III Non ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5539921/

Empowering Survivors After Colorectal and Lung Cancer ... This study evaluates the feasibility and acceptability of a Self-Management Survivorship Care Planning (SM-SCP) intervention in colorectal and lung cancer ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388917301539

Empowering survivors after colorectal and lung cancer ... The SM-SCP intervention was feasible and acceptable for colorectal and lung cancer survivors after treatment completion. Survivorship care interventions have ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28720259/

Empowering survivors after colorectal and lung cancer treatment This study evaluates the feasibility and acceptability of a Self-Management Survivorship Care Planning (SM-SCP) intervention in colorectal and lung cancer ...

5. withpower.com withpower.com/trial/self-management-survivorship-care-for-lung-and-colorectal-cancer-9a50a

Self-Management Survivorship Care for Lung and ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7994229/

Rationale and Design of a Telehealth Self-Management ... This paper describes the rationale and design of an evidence-informed telehealth intervention that integrates shared care coordination between oncology/primary ...