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?

Care Coordination is an essential component of cancer care delivery. Many patients experience poor care coordination. In this study, we hypothesize that provision of a video educational intervention to teach patients about cancer, care coordination and self-advocacy will improve patients' perception of care coordination. Cancer patients with early stage disease scheduled to receive adjuvant therapy, and who reside in a rural area, will be enrolled onto the study. Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer knowledge, self-advocacy and care coordination will be obtained at baseline and after 4-6 months.

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.

Is the Educational Intervention for Early-Stage Cancer Care Coordination safe for humans?

The research articles reviewed do not provide specific safety data for the Educational Intervention for Early-Stage Cancer Care Coordination or its related names. However, they highlight the importance of patient education in cancer care, which generally improves patient satisfaction and outcomes without indicating any safety concerns. ^{1 2 3 4 5}

How is the Table-based Educational Intervention treatment different from other treatments 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 cancer care journey, unlike traditional treatments that may not emphasize patient education and coordination. ^{6 7 8 9 10}

What data supports the effectiveness of the Educational Intervention for Early-Stage Cancer Care Coordination treatment?

The research highlights the importance of patient education and care coordination in cancer treatment, showing that educational interventions can improve patients' understanding and confidence in managing their care. This suggests that similar educational tools, like the Table-based Educational Intervention Tool, may help patients better navigate their cancer treatment and improve their overall care experience. ^{2 11 12 13 14}

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

I have had cancer treated with chemotherapy in the past 3 years.

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

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Measuring cancer care coordination: development and validation of a questionnaire for patients. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs: An importance-performance analysis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Advancing Patient-Centered Cancer Survivorship Care: Evaluation of a Dissemination Project. [2023]

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

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Patient perspectives on treatment decision-making under clinical uncertainty: chemotherapy treatment decisions among stage II colon cancer patients. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Right Information, Right Patient, Right Time: Utilizing the MyCareCompass Platform to Deliver Patient Education in the Oncology Setting. [2023]

7. England 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. [2018]

8. England 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. [2023]

9. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

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

Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. [2021]

11. England pubmed.ncbi.nlm.nih.gov

What are the current barriers to effective cancer care coordination? A qualitative study. [2022]

12. Germany 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. [2022]

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

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Identifying indicators of colorectal cancer care coordination: a Delphi study. [2019]