Survivorship Care for Cancer Survivors

(CASCADE Trial)

Overseen By Bijal Balasubramanian, MBBS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: No cancer history

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering care to cancer survivors. The goal is to determine if this approach improves health outcomes for both patients and their clinicians. Participants who have visited a community health center in the past year and have a history of cancer may be suitable candidates. The trial involves various clinics undergoing phases of control and intervention to assess the impact of the care changes. As an unphased trial, it provides a unique opportunity for patients to contribute to innovative care solutions that could enhance future cancer survivorship experiences.

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

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

What prior data suggests that this survivorship care delivery intervention is safe?

Research has shown that programs designed to support cancer survivors are generally safe. These programs help manage the long-term health of survivors and receive positive feedback from patients. They focus on enhancing health and the overall care experience.

Studies have not reported any major negative effects, confirming the safety of these programs. The goal is to improve health outcomes and provide personalized, effective care. Overall, these programs aim to support the ongoing health and well-being of cancer survivors safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the survivorship care delivery intervention because it's designed to directly address the ongoing needs of cancer survivors, which is a shift from typical post-treatment options that often focus more narrowly on monitoring for cancer recurrence. This intervention is unique as it aims to provide a comprehensive support system that includes physical, emotional, and social care tailored to individual survivor needs, potentially improving quality of life and long-term health outcomes. By integrating care across multiple clinics and testing various durations of control and intervention phases, this trial hopes to reveal the most effective ways to deliver sustained, holistic support to cancer survivors, which could set a new standard in survivorship care.

What evidence suggests that this survivorship care delivery intervention could be effective for cancer survivors?

Studies have shown that survivorship care plans can improve the quality of life for people who have had cancer. These plans, tailored to individual needs, enhance both social and physical well-being. In this trial, different clinics will implement the survivorship care delivery intervention at various stages, allowing researchers to assess its impact over time. Early results suggest that these plans help doctors and nurses transition cancer survivors to regular healthcare, easing ongoing health management. However, some reviews have noted no significant changes in patient satisfaction or mood. Overall, the goal is to support survivors in their health journey after treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Bijal Balasubramanian, MBBS, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Simon Craddock Lee, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who have survived cancer and are receiving care at community health centers. It aims to involve clinicians, patients, and community members in enhancing survivorship care.

Inclusion Criteria

Participants: at least one visit to the Community Health Centers (CHCs) in the prior year

Clinicians: employed clinicians (e.g. physicians, nurses, pharmacists, or other allied health professionals) and non-clinician staff of the participating CHC clinics

Exclusion Criteria

I have never had cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Clinics operate under control conditions to establish baseline data

6-24 months

Intervention

Implementation of cancer survivorship care delivery intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Survivorship care delivery intervention

Trial Overview The study tests a new way of delivering care to cancer survivors at clinics. It looks at how effective this approach is in improving outcomes for both patients and doctors using mixed methods guided by the Practice Change Model.

How Is the Trial Designed?

Group I: Step 4 (2 clinics)- 24 months control then 12 months intervention Experimental Treatment 1 Intervention

Group II: Step 3 (2 clinics)-18 months control then 12 months intervention Experimental Treatment 1 Intervention

Group III: Step 2 (2 clinics)-12 months control then 12 months intervention Experimental Treatment 1 Intervention

Group IV: Step 1 (2 clinics)-6 months control then 12 months intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

The Robert H Lurie Comprehensive Cancer Center successfully implemented cancer survivorship care plans (SCPs) for patients completing primary cancer treatment, utilizing clinician and patient feedback to create customized templates that streamline the process.

The SCP templates significantly reduced the time clinicians spent completing them, averaging just 12 minutes, and auto-populated 20% of the required fields, enhancing efficiency and supporting better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care planning in a comprehensive cancer center using an implementation framework. Garcia, SF., Kircher, SM., Oden, M., et al.[2016]

There are over 13 million adult cancer survivors in the U.S., but their care is often poorly coordinated, highlighting the need for effective survivorship care plans (SCPs) as recommended by the Institute of Medicine.

Despite the requirement for SCPs by the American College of Surgeons, many cancer centers face significant barriers in implementing these plans, such as time constraints and resource limitations, although research is emerging to support effective delivery models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the commission on cancer standards for survivorship care plans. Stricker, CT., O'Brien, M.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.39.28_suppl.19

Feasibility and preliminary effectiveness of a cancer ... Preliminary results indicate that START helped providers to transition eligible survivors to primary care. We have successfully engaged cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7011634/

Survivorship Care Plans in Cancer: A Meta‐Analysis and ... Our meta‐analysis compares patient‐reported outcomes between SCP and no SCP (control) conditions for cancer survivors.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125000412

Effectiveness of tailored interventions on quality of life in ... Tailored interventions can improve social and physical quality of life and general health in cancer survivors. •. Remote, iterative tailored interventions can ...

4. link.springer.com link.springer.com/article/10.1007/s11764-024-01609-z

A scoping review of the evidence on survivorship care ... This study found no significant improvements in patient-reported outcomes like treatment satisfaction, survivor concerns, depression, and impact ...

5. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/research/survivorship-cancer-outcomes-research-initiative/research-clinical-trials

Survivorship and Cancer Care Delivery Research and ... SCOR researchers investigate survivorship from all angles and conduct clinical trials in order to find the best possible treatments for patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12546521/

A scoping review of the evidence on survivorship care plans ... Systematic review of the impact of cancer survivorship care plans on health outcomes and health care delivery. J Clin Oncol. 2018;36(20): ...

7. cancercontrol.cancer.gov cancercontrol.cancer.gov/ocs/special-focus-areas/models-of-survivorship-care

Models of Survivorship Care Risk-stratified survivorship care describes a personalized approach in which cancer survivors are triaged, or stratified, to distinct care ...

8. ascopubs.org ascopubs.org/doi/10.1200/OP.23.00716

Survivorship Care for People Affected by Advanced or ... These MASCC-ASCO standards support optimization of health outcomes and care experiences by providing guidance to stakeholders.

9. academic.oup.com academic.oup.com/jnci/article/116/11/1784/7713374

Prevalence of cancer survivors in the United States | JNCI Among this group, prevalence is expected to increase from 5.6 million (31%) of all survivors in 2022 to 10.4 million (40%) of all survivors in ...

10. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-023-01326-8

Factors influencing implementation of a care coordination ... More cancer survivorship care delivery research embedded in safety ... care delivery and health outcomes for cancer survivors. Availability ...