Survivorship Care Interventions for Cancer

Recruiting at 3 trial locations

Overseen By Emma Schremp

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Debra Friedman

Disqualifiers: Non-English speakers, Under 18, others

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

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to support cancer survivors in managing their health after treatment. It focuses on telehealth (health services provided via electronic communication) and patient navigation (a support service to guide patients through the healthcare system) to help survivors in rural areas access care. The trial seeks participants who have completed treatment for early-stage cancer (Stage 0-III) within the past year and are in complete remission. Those who have recently finished cancer treatment and live in a rural area might find this trial a good fit. As an unphased trial, it offers a unique opportunity to contribute to innovative support strategies for cancer survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these survivorship care interventions are safe?

Research shows that both Survivorship Patient Navigation and Telehealth Survivorship Visits are generally safe for cancer survivors.

Studies on patient navigation indicate it is well-received and improves patients' quality of life and satisfaction with their care. For example, a review found that 70% of patients experienced better treatment timelines with navigation support. Another study found that navigation works well and is accepted in hospitals.

For telehealth visits, research suggests they are safe and offer significant benefits. Some studies have shown that telehealth can deliver personalized care plans as effectively as in-person visits. Cancer survivors have reported positive experiences with telehealth, and it has been shown to help reduce healthcare inequalities.

Overall, both interventions have strong safety records, making them promising options for supporting cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer innovative ways to support cancer survivors, especially in rural areas. The Survivorship Patient Navigation Intervention provides personalized guidance to help patients navigate the complex healthcare system, ensuring they get the care they need. Meanwhile, the Telehealth Survivorship Visit Intervention leverages electronic communication technologies to deliver survivorship care remotely, making it more accessible and convenient for those living far from medical centers. These approaches aim to improve the overall quality of life for cancer survivors by addressing unique challenges not typically covered by standard in-person follow-up care.

What evidence suggests that these survivorship care interventions could be effective for cancer survivors?

This trial will compare two interventions: the Survivorship Patient Navigation Intervention and the Telehealth Survivorship Visit Intervention. Studies have shown that patient navigation can significantly reduce the time it takes for cancer patients to begin treatment. About 70% of patients who received these services experienced these benefits. Additionally, patient navigation has been linked to improved quality of life and higher satisfaction with care during recovery.

Research indicates that telehealth, which involves healthcare services provided through electronic communication, can effectively address both the emotional and physical effects of cancer. Telehealth is particularly beneficial for patients in rural areas, as it makes cancer care more accessible. It also helps reduce disparities in care outcomes between patients who can easily visit hospitals and those who cannot. ^{1 2 3 4 5}

Who Is on the Research Team?

Debra L. Friedman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults who finished cancer treatment within the last year, aimed at curing Stage 0 - III cancer, and are now in complete remission. They must be able to give informed consent.

Inclusion Criteria

I am 18 years or older and have cancer.

I finished my cancer treatment in the last year and am now cancer-free.

I was treated for early-stage cancer with the goal of curing it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Pilot test the implementation of guideline-based survivorship care planning using patient navigation and telehealth

8-12 weeks

Telehealth sessions and patient navigator interactions

Follow-up

Participants are monitored for adherence to recommended disease surveillance and health assessment practices

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship Patient Navigation Intervention
• Telehealth Survivorship Visit Intervention

Trial Overview The study tests a new approach to post-cancer care in rural areas using two methods: Survivorship Patient Navigation Intervention and Telehealth Survivorship Visit Intervention. It's a pilot study meant to guide future larger studies.

How Is the Trial Designed?

Group I: Survivorship care Experimental Treatment 2 Interventions

Participants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator.

Who Is Running the Clinical Trial?

Debra Friedman

Lead Sponsor

Trials

2

Recruited

850+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Telehealth is a promising and feasible option for supporting cancer survivors, particularly in enhancing their physical and mental quality of life during the extended survival phase (1 to 3 years post-diagnosis).

However, there is a notable lack of telehealth interventions specifically designed for long-term survivors (over 5 years post-diagnosis), highlighting a gap in care that needs to be addressed, especially regarding their social and spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth Among Cancer Survivors: A Scoping Review. Irurita-Morales, P., Soto-Ruiz, N., Martín-Rodríguez, LS., et al.[2023]

Telehealth could significantly improve cancer survivorship care planning by facilitating better communication and coordination between oncology and primary care providers, as well as enhancing survivor access to care.

Despite its potential, there are important challenges to address, such as scheduling coordination among clinicians and ensuring fair payment for telehealth services, to fully realize the benefits of telehealth in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From active treatment to surveillance: How the barriers and facilitators of implementing survivorship care planning could be an opportunity for telehealth in oncology care for rural patients. Alford-Teaster, J., Vaclavik, DD., Imset, I., et al.[2023]

The CDC's National Program of Cancer Registries collects comprehensive cancer data on 96% of the U.S. population, which is crucial for understanding cancer incidence, treatment, and outcomes.

Recent advancements in cancer surveillance by the CDC enhance the ability to recruit participants for survivorship research and improve the sharing of treatment summaries, ultimately benefiting cancer survivors and their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. Ryerson, AB., Eheman, C., Styles, T., et al.[2019]

Telehealth could significantly improve cancer survivorship care planning by facilitating better communication and coordination between oncology and primary care providers, as well as enhancing access for survivors, based on a mixed-methods study involving interviews and surveys with providers and survivors in Vermont and New Hampshire.

Despite the potential benefits, challenges such as scheduling coordination among clinicians and ensuring payment parity for telehealth services need to be addressed to fully realize the advantages of telehealth in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From active treatment to surveillance: how the barriers and facilitators of implementing survivorship care planning could be an opportunity for telehealth in oncology care for rural patients. Alford-Teaster, J., Vaclavik, D., Imset, I., et al.[2023]

The POSTCARE intervention, which involves a single coaching session using motivational interviewing techniques, significantly improved self-reported health and reduced social role limitations among 79 breast cancer survivors compared to usual care.

Participants in the POSTCARE group also showed clinically meaningful improvements in quality of life, particularly in physical role, bodily pain, and emotional role, suggesting that this approach enhances care coordination and patient outcomes during the transition from cancer care to self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered support in the survivorship care transition: Outcomes from the Patient-Owned Survivorship Care Plan Intervention. Kvale, EA., Huang, CS., Meneses, KM., et al.[2017]

Patient navigation programs can significantly increase the rates of post-treatment surveillance mammography in women with breast cancer, suggesting a benefit in monitoring after treatment.

However, there is limited evidence that patient navigation improves treatment outcomes during breast cancer care, indicating a need for further research to fully understand its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. Baik, SH., Gallo, LC., Wells, KJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review Of these, 70% (n = 16) reported a significant reduction in time to treatment with patients that received navigation. These positive outcomes were observed ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Emerging evidence suggests that patient navigation improves quality of life and patient satisfaction with care in the survivorship phase and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425001466

Assessing the effect of virtual navigation interventions to ... This trial will elucidate the potential effectiveness and implementation of health insurance navigation programs that may benefit many cancer survivors.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11219419

Acceptability and Feasibility of Survivorship Group Medical ... Our study found that patient-navigator-facilitated GMV was both feasible and acceptable in a safety-net hospital setting. Pre- and post-surveys ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03271099

Patient Navigation in Cancer Survivorship at a Safety Net ... This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive ...