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

Trial Summary

What is the purpose of this trial?

Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.

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 data supports the effectiveness of the treatment Survivorship Patient Navigation Intervention, Telehealth Survivorship Visit Intervention for cancer?

Research shows that patient navigation helps improve cancer outcomes by reducing barriers and ensuring timely access to care, which can be beneficial during cancer treatment and survivorship. Additionally, telehealth offers opportunities to enhance survivorship care, especially for patients in rural areas, by making it easier to access necessary support and resources. ^{1 2 3 4 5}

Is the Survivorship Care Intervention safe for humans?

The research articles do not provide specific safety data for Survivorship Care Interventions, but they focus on improving access to care and quality of life for cancer survivors, suggesting that these interventions are generally considered safe and beneficial for patients. ^{2 3 6 7 8}

How is the Survivorship Patient Navigation and Telehealth Visit Intervention different from other cancer survivorship treatments?

This treatment is unique because it combines patient navigation and telehealth visits to support cancer survivors, especially those in rural areas, by improving access to care and personalized support. Unlike traditional in-person follow-ups, it leverages technology to facilitate ongoing care and address the specific needs of survivors, which are often overlooked. ^{1 2 6 9 10}

Research Team

Debra L. Friedman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

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

Patient-centered support in the survivorship care transition: Outcomes from the Patient-Owned Survivorship Care Plan Intervention. [2017]

2. United States 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. [2023]

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

Patient Navigation in Breast Cancer Treatment and Survivorship: A Systematic Review. [2019]

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

Defining a patient-centered approach to cancer survivorship care: development of the patient centered survivorship care index (PC-SCI). [2022]

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

Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer. [2023]

6. United States 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. [2023]

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

Survivorship navigation outcome measures: a report from the ACS patient navigation working group on survivorship navigation. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. [2019]

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

Use of Telehealth Among Cancer Survivors: A Scoping Review. [2023]

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

Improving breast cancer survivors' knowledge using a patient-centered intervention. [2018]