Individuals who screen positive will all move forward to receive this intervention. This includes connection to community partners with financial education and easily accessible resources, and a vocational navigation and support consultation for caregivers for 6-months.

The investigator anticipates that this will include a baseline financial, education and vocational assessment, likely using a virtual platform. Participants who screen positive will be connected to community resources and for consultation. There will be a 1-month, 3-month and 6-month check-in to address any financial concerns through additional counseling/navigation.

Needs navigation intervention

Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO

Rhea Khurana, BS

The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer.

Financial toxicity, the negative personal financial impact of healthcare,13 is a highly prevalent adverse effect of cancer treatment, and AYA cancer survivors experience disproportionately higher rates of financial toxicity compared to older cancer survivors. Financial toxicity is associated with poorer overall survival and bankruptcy, and AYA survivors are 10 times more likely to file for bankruptcy than older cancer survivors. Thus, financial toxicity and unmet HRSN (health-related social needs) are key contributors to employment and health outcome disparities seen among AYA survivors living in areas of persistent poverty.

Our team has focused on addressing unmet HRSN and reducing outcome disparities among AYA cancer survivors, many of whom live in areas of persistent poverty. We have adapted a model of financial navigation that reduces financial toxicity among older adults with cancer, informed by qualitative research among Spanish- and English-speaking AYAs and their caregivers from our local community.

We have identified community and clinical partners poised to address these unique unmet needs. These partners have expertise in educational navigation and caregiver community resources - both cited as unmet needs in our pilot study. Using mixed methods, we will refine (Aim 1 - already completed) and pilot test (Aims 2 and 3) a tailored version of our intervention among 30 English and Spanish-speaking caregivers of younger AYAs who screen positive for severe financial toxicity or unmet HRSN.

Participants who screen positive all move forward to receive the intervention

Needs Navigation for Caregivers of AYAs

Leveraging COmmunity Partnered nEeds Navigation to Reduce Unmet Health-related Social Needs Among Caregivers for Adolescent and Younger Adult Cancer Survivors

This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact for consultation and with community partners at any time before the end of 6 months.

This is to measure interest and the need for help by the intervention that can provide caregiver / patient financial education and navigation

The PFWS/ COST is a participant-reported outcome measure that describes financial distress in cancer patients or their caregivers.

Columbia University

Assistant Professor of Nursing

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The investigators will determine the best intervention and strategy (and thus implementers) based on high ranking barriers/facilitators identified in focus groups. A minimum of 2 implementation strategies will be developed and implemented at each level (patient, provider, system) at each site that considers (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected. Each community health center (CHC) will serve as its own separate subject, and individual strategies will be tested using single case experimental design (SCED) at each CHC using component analysis to rapidly test and optimize our strategies. In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured.

The investigators will be conducting focus groups and identifying barriers and facilitators, and the investigators will be matching identified barriers and facilitators to implementation strategies at the patient, provider, and system level which the investigators will be testing using rapid-cycle methods.

Implementation Science Strategy

Adjoa Anyane-Yeboa, MD, MPH

Nathan Yoguez, MPH

Stephen Tringale, MD

Madhur Kuckreja, MD

Heidi Emerson, PhD

Lisa Jones, MD

The investigators will use a mixed methods study i.e. focus groups involving CHC staff as well as quantitative study which involves analyzing data that is available from the EHR and DRVS population management platform.

Aim 1: Describe the demographics of the populations aged 45 - 49, 50-4, and over 55 to understand baseline screening needs and disparities.

Overview: The investigators will characterize the population in these age groups in order to understand resources needed to screen patients at age 50 and to expand screening to the USPSTF's draft guideline if passed.

Setting: The investigators will select 4 CHCs with distinctly diverse populations for Aim 1 and Aim 2.

Approach: The investigators will examine data from the EHR and the DRVS platform to determine: (1) the size and demographics of the three age groups; (2) the frequency in which this population presents to the CHC for primary care and other visits; and (3) current screening initiation patterns. Based on the findings of the investigator's initial evaluation, the investigators will estimate the additional colorectal cancer screening tests that will be required to screen this population promptly at age 50 and the additional resources that will be needed at each health center to meet this need. The investigators will also estimate the impact of a lower age of screening initiation. Analysis will be stratified by race/ethnicity, gender, age and insurance status to assess for any disparities that might be present.

Data Collection and Management: The DRVS population management platform provides the data needed to evaluate Aim 1. The Implementation Science Center for Cancer Control Equity (ISCCCE) data management team will pull the data needed for the participating CHCs, once selected. The investigators have existing data use agreements that will be amended for this specific project. Data flows and management procedures have already been established and will serve to expedite this study.

Aim 2: Conduct focus groups with key personnel to identify barriers and facilitators to screening in 4 different health centers with uniquely diverse populations.

Overview: The investigators will conduct focus groups to understand barriers and facilitators to colorectal cancer screening including perceptions around the change in screening age, attitudes about specific strategies to facilitate colorectal cancer screening (e.g. use of technological-based solutions to prompt screening, task shifting with integration of medical assistants into the screening process), proposed strategies to improve screening at the health center, and other likely barriers and facilitators.

Approach: The investigators will conduct focus groups with key personnel at the 4 participating health centers. The investigators will include an administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice managers, medical assistants, and providers (MD, NP, and/or PA). Focus groups will address: (1) barriers and facilitators to timely screening initiation; (2) perceptions around using technological solutions to prompt colorectal cancer screening; and (3) perceptions about task-shifting with integration of the medical assistants into the colorectal cancer screening process. Distinct barriers and facilitators/determinants will be identified at the patient, provider and system-level. These determinants will be prioritized (high, medium, low) based on number of times referenced in the interviews.

Data Analysis: Focus group data will be analyzed to identify key themes related to barriers and facilitators to screening.

Outcomes: The outcome of this aim will be identified barriers and facilitators to colorectal cancer screening at health centers with a key focus on understanding perceptions around utilization of technological solutions (e.g. pre-existing text message platforms at health centers, electronic registries) and integration of the medical assistants into the CRC screening workflow.

Aim 3: Develop and test intervention components to anticipate and address barriers and facilitators at the patient, provider and system-level using rapid cycle methods.

Overview: We will identify implementation strategies at patient, provider and systems-levels and match to identified Aim 2 barriers and facilitators, use design probes to understand the workflows and preconditions for implementation strategies, and individually test strategies using rapid cycle methods.

Approach:

* Development of Implementation Strategies: High ranking barriers from Aim 2 will be matched with implementation strategies that are most likely to influence implementation outcomes. A minimum of 2 implementation strategies will be developed at each level. When identifying strategies, we will consider the: (1) implementation strategy; (2) mechanism in which the strategy impacts the identified determinant (3) the determinant; (4) moderators that may influence the impact of the strategy; (5) the preconditions necessary for successful implementation; and (6) implementation outcomes affected.
* Design Probes: We will conduct design probes to understand the culture, climate and preconditions to implementation at each health center. We will use design probes to further understand the day-to-day workings at the health center and workflows. We will further tailor our implementation strategies based on additional barriers and facilitators that are identified from design probes.
* Rapid Cycle Testing: Individual strategies will be tested using single case experimental design (SCED). In SCED each subject serves as their own control, an intervention is systematically introduced and withdrawn, and the effects of the intervention are measured. For our study each CHC will serve as a separate subject. We will conduct a series of single case experiments at each CHC using component analysis to rapidly test and optimize our strategies. Component analysis allows researchers to assess several interventions or components of an intervention individually or as a treatment package in multiple assessments. A minimum of 2 strategies at each level (patient, provider, system) will be tested at each clinic site. For example, a patient-level strategy might include text messaging to patients, which is enabled by the DRVS platform. We might test whether single or multiple text messages around a patient's birthday can prompt screening uptake, or if messages prior to a health care visit increases uptake of screening offered. An example at the provider-level might include the impact of a motivational training if staff identify difficulty motivating patients as a barrier. A systems-level strategy might include incorporating CRC screening into the workflows of the health center using the medical assistants, if provider time limitations are identified as a barrier.
* Post-Implementation Survey: When implementation testing ends, our team will send out a survey to any CHC staff member (administrative leader and population health managers, data analysts and quality improvement staff, as well as nurse/practice manager, medical assistant, and provider \[MD, NP, and/or PA\]) involved with the implementation of strategies at the health center level, and the survey information we will collect will assess perceptions on feasibility, appropriateness, and acceptability of the implementation strategy used.

The investigators will use a mixed methods approach involving qualitative focus groups with health center providers and staff to identify barriers and facilitators to screening, and implementation science methods to test multilevel implementation strategies at the health centers.

Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study

No IPD will be shared with other researchers.

The investigators will measure the acceptability of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The investigators will measure the feasibility of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The investigators will measure the appropriateness of the implementation strategies determined in Aim 2. This will be measured through a post-implementation survey given to the CHC staff members who participate in systems-level implementation at the two CHC pilot test sites in Aim 3.

The secondary outcomes will be change in colorectal cancer screening rate. This will be measured by the difference in the colorectal cancer screening tests ordered and completed compared to the pre-implementation period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Needs Navigation for Caregivers of AYAs	NCT06296641	Cancer in Adole...	Needs navigatio...	15 Years - 26 Years	Columbia University
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study	NCT05524428	Colo-rectal Can...	Implementation ...	18 Years -	Massachusetts General Hospital
Eliminating Barriers to Colorectal Cancer Screening Using Rapid Cycle Testing: A Pilot Study	NCT05524428	Colo-rectal Can...	Implementation ...	18 Years -	Massachusetts General Hospital

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