Educational Intervention for Early-Stage Cancer Care Coordination

Overseen By Randall F Holcombe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Prior malignancy, Neuro-cognitive impairment, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a video-based educational tool, the Table-based Educational Intervention, can help cancer patients feel more in control and coordinated in their care. The focus is on individuals with early-stage breast, lung, or colon cancer who are starting or soon to start additional therapy and live in rural areas. Participants will receive the educational tool either at the start or after four months of therapy to compare the effects. Ideal candidates live in rural Vermont and have been diagnosed with stage I, II, or III breast, lung, or colon cancer. As an unphased trial, this study offers a unique opportunity for patients to contribute to research that could enhance cancer care coordination and empowerment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational intervention rather than medication changes.

What prior data suggests that this educational intervention is safe for cancer patients?

Research shows that patients generally find educational programs easy to handle. These programs typically help patients learn more and manage their care better. Without involving medication or medical procedures, they have no reported physical side effects.

Studies reviewing educational tools for cancer patients found no negative effects. This is expected, as these programs aim to inform and empower patients, not alter their physical health directly. Participants in similar studies have used educational tools without known health risks. Therefore, this video-based educational program should be safe for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve early-stage cancer care coordination using educational interventions. Unlike standard treatment options that primarily focus on medical procedures and medications, this approach aims to empower patients with knowledge through a video-based intervention delivered via tablet. By enhancing patients' understanding of their treatment and care pathway, this method could lead to better patient engagement and potentially improve overall care outcomes. Additionally, comparing the impact of receiving this education upfront versus a delayed approach could provide insights into optimizing the timing of patient education for maximum benefit.

What evidence suggests that this educational intervention is effective for improving care coordination in early-stage cancer patients?

Research has shown that educational programs can make cancer care easier to manage. In this trial, participants will receive a video-based educational intervention on a tablet. One study found that a similar video tool helped cancer patients understand their care better, increasing their knowledge and confidence in managing treatment. Another review found that such programs effectively teach patients and caregivers, leading to better health outcomes. For people with early-stage cancer, these educational tools show promise in helping them navigate their care journey more effectively. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in rural Vermont with early-stage (I, II, or III) breast, lung, or colon cancer who are about to start or have just started adjuvant chemotherapy. They must understand English and cannot have had chemotherapy for another cancer within the last three years.

Inclusion Criteria

Rural residence location in Vermont (outside Chittenden County)

Proficient in English

I have been diagnosed with breast, lung, or colon cancer.

Exclusion Criteria

Known or suspected neuro-cognitive impairment

Resident of Chittenden County, Vermont

My cancer is not stage I, II, or III breast, colon, or lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline survey instruments to assess cancer knowledge, self-advocacy, and care coordination

1 week

1 visit (in-person)

Educational Intervention

Participants receive a video-based educational intervention either upfront or after 4 months of therapy

4-6 months

1 visit (in-person or virtual)

Follow-up Assessment

Participants complete follow-up surveys to reassess cancer knowledge, self-advocacy, and care coordination

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in perception of care coordination and self-advocacy after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Table-based Educational Intervention

Trial Overview The study tests a video educational tool designed to improve understanding of cancer care coordination and self-advocacy among patients. Participants will be randomly assigned to receive this intervention either at the beginning of their therapy or after four months.

How Is the Trial Designed?

Group I: Upfront Educational Intervention Experimental Treatment 1 Intervention

Participants will receive a video-based intervention after completing baseline survey instruments and prior to retesting after 4-6 months.

Group II: Delayed Educational Intervention Experimental Treatment 1 Intervention

Participants will complete baseline survey instruments and again complete surveys after 4-6 months. They will then receive the video-based educational tablet.

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Published Research Related to This Trial

In a study involving 85 healthcare professionals and patients across four Belgian hospitals, over half of the evaluated key elements for patient-centered care in oral anticancer drug treatment were found to be either not performed or not systematically performed, particularly in areas like care coordination and medication counseling.

Despite the moderate performance of these key elements, nearly all participants rated them as highly important, indicating a significant gap between perceived importance and actual implementation, highlighting the need for improved strategies in patient education and care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs: An importance-performance analysis. Kinnaer, LM., Nelis, M., Van Hecke, A., et al.[2020]

A national panel of 20 experts reached consensus on 15 valid indicators of colorectal cancer care coordination from an initial list of 41, focusing on communication quality and appropriateness of care.

These indicators, such as the clarity of discharge letters and documentation of multidisciplinary team outcomes, can be used in a medical record audit tool to objectively assess and improve cancer care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying indicators of colorectal cancer care coordination: a Delphi study. Young, JM., Masya, LM., Solomon, MJ., et al.[2019]

The Care Coordination Instrument (CCI), a 29-item questionnaire, effectively assesses patients' perceptions of cancer care coordination, highlighting its importance in improving cancer care delivery.

Factors such as having a family caregiver and a diagnosis of blood cancer are linked to better perceptions of care coordination, while head and neck cancer patients and those without caregiver support report poorer coordination, indicating areas for targeted improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. Okado, I., Cassel, K., Pagano, I., et al.[2021]

In a study of 368 cancer survivors, having a cancer care coordinator (CCC) significantly improved physical health-related quality of life (HRQoL) for patients with low health literacy, indicating that CCCs can help vulnerable patients navigate healthcare challenges more effectively.

While overall physical HRQoL was not significantly associated with having a CCC for all patients, the positive impact on those with low health literacy suggests that targeted support may enhance recovery and well-being in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between health literacy, having a cancer care coordinator, and long-term health-related quality of life among cancer survivors. Del Vecchio, NJ., McDowell, BD., Carter, KD., et al.[2022]

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

The Advancing Patient-Centered Cancer Survivorship Care Toolkit effectively improved healthcare providers' confidence and knowledge regarding patient priorities in cancer survivorship care, as evidenced by significant pre- and post-test score improvements among 212 e-learning participants and 121 workshop trainees.

The Toolkit's dissemination through various platforms, including e-learning and social media, reached over 10,000 individuals, demonstrating its potential to enhance care coordination among primary care providers and oncologists in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Patient-Centered Cancer Survivorship Care: Evaluation of a Dissemination Project. Shirima, S., Brazinskaite, R., Killackey, M., et al.[2023]

A survey of 17 young adult cancer patients revealed that while most understood their treatment, 24% did not receive guidance on what to do if they missed a dose, indicating a gap in medication education.

Common barriers to adherence included side effects (59%), forgetfulness (47%), and depressive symptoms (35%), highlighting the need for improved support systems and education involving family and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the need for improved strategies and medication-related education to increase adherence for oral anticancer medications in the young adult oncology population. Divakaruni, A., Saylor, E., Duffy, AP.[2018]

A new questionnaire was developed to measure patients' experiences of cancer care coordination, tested on 686 patients in New South Wales, Australia, and showed strong reliability and internal consistency (Cronbach's alpha 0.88).

The final instrument consists of 20 items divided into two factors, 'Communication' and 'Navigation', which effectively capture the quality of care coordination and can be used in future studies to improve cancer care services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring cancer care coordination: development and validation of a questionnaire for patients. Young, JM., Walsh, J., Butow, PN., et al.[2022]

A study involving 31 stage II colon cancer patients revealed that many felt unclear about the risks and benefits of adjuvant chemotherapy (ACT), highlighting inconsistencies in how healthcare providers communicated these aspects.

Patients often preferred clear treatment recommendations from their providers, which sometimes limited their involvement in shared decision-making, indicating a need for better communication strategies to help patients understand their treatment options and make informed choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives on treatment decision-making under clinical uncertainty: chemotherapy treatment decisions among stage II colon cancer patients. Brotzman, LE., Crookes, DM., Austin, JD., et al.[2023]

Digital health education, like the MyCareCompass system used in a pilot at Fox Chase Cancer Center, significantly improved patient engagement and satisfaction by providing timely and relevant educational materials about their procedures.

The automated delivery of educational content was effective without increasing the workload for healthcare providers, suggesting a promising approach to enhance patient education in routine cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right Information, Right Patient, Right Time: Utilizing the MyCareCompass Platform to Deliver Patient Education in the Oncology Setting. Fleisher, L., Kenny, C., Rusten, C., et al.[2023]

The 'Vamos a educarnos contra el cáncer' webinar series effectively reached 297 participants, with 90% rating the sessions as good or excellent, demonstrating its efficacy in educating the Hispanic/Latino community about cancer.

The series encouraged 86% of participants to adopt or improve cancer-related behaviors, indicating a successful implementation of community-based education that can be maintained for future outreach efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Spanish-Language Cancer Educational Webinar Series "Vamos a educarnos contra el cáncer" with the RE-AIM Framework. Rivas, G., Rodríguez-Colon, S., Ramírez, SI., et al.[2023]

A qualitative study involving 20 patients, 4 carers, and 29 health professionals identified key barriers to effective cancer care coordination, including unclear roles of health professionals and poor communication between specialists and primary care.

The findings highlight the need for improved multidisciplinary team meetings and better resource management to enhance cancer care delivery, suggesting that targeted interventions are necessary for service improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the current barriers to effective cancer care coordination? A qualitative study. Walsh, J., Harrison, JD., Young, JM., et al.[2022]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05723250

Care Coordination Educational Intervention Study for ... Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12310782/

Feasibility of a Remote Patient Video Education ... In this study, we assessed the feasibility and efficacy of a remote, tablet-based patient video education intervention focused on cancer care ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05723250/care-coordination-educational-intervention-study-for-patients-from-rural-areas-with-early-stage-cancer

Care Coordination Educational Intervention Study for ... Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2).

4. sciencedirect.com sciencedirect.com/science/article/pii/S0749208123001183

A Systematic Review of Educational Interventions to Equip ... This systematic review aimed to determine the content, mode of delivery, assessment, and outcomes of educational interventions to equip health and social ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11240398/

The Impact of Pain Education Interventions for Cancer ... Implementing educational programs for patients and their caregivers has been suggested as an effective method to help alleviate pain associated with cancer.

6. withpower.com withpower.com/trial/phase-malignancies-1-2023-67285

Educational Intervention for Early-Stage Cancer Care Coordination The Table-based Educational Intervention is unique because it focuses on improving care coordination through education, helping patients better navigate their ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12015717/

Mapping evidence on educational interventions for ... This scoping review aims to map the existing evidence on educational interventions tailored for adolescents with cancer, identifying gaps in the literature

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388920300454

Patient-centered care coordination, education and ... To analyse the importance and performance of key elements in patient-centered care coordination, education and counseling of patients treated with oral ...