CancerNCT05723250
Care Coordination Educational Intervention Study for Patients From Rural Areas With Early Stage Cancer
A study testing Table-based Educational Intervention in people with Cancer, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Table-based Educational Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- Breast, lung, or colon cancer diagnosis
- Stage I, II or III cancer
- Adjuvant chemotherapy started < 30 days or planned within the next 30 days
- Rural residence location in Vermont (outside Chittenden County)
- Proficient in English
Who cannot join
- History of prior malignancy treated with chemotherapy in last 3 years
- Known or suspected neuro-cognitive impairment
- Resident of Chittenden County, Vermont
- Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Cancer Center
Burlington, Vermont, 05405
Randall F Holcombe
About this study
Official title: Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: A Feasibility Study
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.
- Conditions
- Cancer
- Being tested
- Table-based Educational Intervention
- Keywords
- healthcare delivery, care coordination, early stage cancer, educational intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Table-based Educational InterventionOther
Also called Educational
Tablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy.
| Study group | Role | What they receive |
|---|---|---|
| Upfront Educational Intervention | Experimental | Participants will receive a video-based intervention after completing baseline survey instruments and prior to retesting after 4-6 months. Receives: Other: Table-based Educational Intervention |
| Delayed Educational Intervention | Experimental | Participants will complete baseline survey instruments and again complete surveys after 4-6 months. They will then receive the video-based educational tablet. Receives: Other: Table-based Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Coordination Instrument Score
Participants complete the Care Coordination Instrument (CCI), a 29-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 3 to Strongly Disagree = 0). A total score is generated by summing the item scores; possible total scores range from 0-87. Higher scores represent a greater perception of care coordination.
Measured: Baseline and 4 months
Secondary outcomes (3)
Cancer Knowledge
Participants complete the Cancer Knowledge Assessment Test (C-KAT). The test includes 5 multiple choice items. A total score is generated by summing the number of correct responses; total scores range from 0-5. Higher scores represent greater cancer knowledge.
Measured: Baseline and 4 months
Satisfaction with Educational Videos
Participants in the baseline intervention group complete the Satisfaction and Acceptability Questionnaire. This 5-item questionnaire assesses how helpful and easily accessible the educational videos were. There is also an open-ended question for other feedback. Answering yes to the items indicates greater satisfaction and ease of use.
Measured: 4 months
Self-Advocacy Score
Participants complete the Cancer Self-Advocacy Scale, a 20-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 6 to Strongly Disagree = 1). A total score is generated by summing the item scores; possible total scores range from 20-120. Higher scores represent greater self-advocacy skills.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start31 Mar 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall F Holcombe, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723250
- Sponsor's protocol ID
- 00002358
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, with removal of PHI
Publications
Okado I, Cassel K, Pagano I, Holcombe RF. Development and psychometric evaluation of a questionnaire to measure cancer patients' perception of care coordination. BMC Health Serv Res. 2020 Jan 21;20(1):52. doi: 10.1186/s12913-020-4905-4.
PubMed 31964391Okado I, Cassel K, Pagano I, Holcombe RF. Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. JCO Oncol Pract. 2020 Aug;16(8):e726-e733. doi: 10.1200/JOP.19.00509. Epub 2020 Mar 27.
PubMed 32216713Okado I, Pagano I, Cassel K, Holcombe RF. Perceptions of care coordination in cancer patient-family caregiver dyads. Support Care Cancer. 2021 May;29(5):2645-2652. doi: 10.1007/s00520-020-05764-8. Epub 2020 Sep 24.
PubMed 32970231
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05723250
- Acronym / sponsor ID
- 00002358
- Conditions
- Cancer
- Keywords
- healthcare delivery, care coordination, early stage cancer, educational intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront Educational Intervention | Experimental | Other: Table-based Educational InterventionParticipants will receive a video-based intervention after completing baseline survey instruments and prior to retesting after 4-6 months. |
| Delayed Educational Intervention | Experimental | Other: Table-based Educational InterventionParticipants will complete baseline survey instruments and again complete surveys after 4-6 months. They will then receive the video-based educational tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18+ years of age
- Breast, lung, or colon cancer diagnosis
- Stage I, II or III cancer
- Adjuvant chemotherapy started < 30 days or planned within the next 30 days
- Rural residence location in Vermont (outside Chittenden County)
Key exclusion criteria (4 listed)
- History of prior malignancy treated with chemotherapy in last 3 years
- Known or suspected neuro-cognitive impairment
- Resident of Chittenden County, Vermont
- Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Table-based Educational InterventionAlso: EducationalTablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy. | Other | Delayed Educational Intervention, Upfront Educational Intervention |
Primary outcome
Care Coordination Instrument Score
Time frame: Baseline and 4 months
Participants complete the Care Coordination Instrument (CCI), a 29-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 3 to Strongly Disagree = 0). A total score is generated by summing the item scores; possible total scores range from 0-87. Higher scores represent a greater perception of care coordination.
3 secondary outcomes
Cancer Knowledge
Time frame: Baseline and 4 months
Satisfaction with Educational Videos
Time frame: 4 months
Self-Advocacy Score
Time frame: Baseline and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 31964391Okado I, Cassel K, Pagano I, Holcombe RF. Development and psychometric evaluation of a questionnaire to measure cancer patients' perception of care coordination. BMC Health Serv Res. 2020 Jan 21;20(1):52. doi: 10.1186/s12913-020-4905-4.
- Background: PubMed 32216713Okado I, Cassel K, Pagano I, Holcombe RF. Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. JCO Oncol Pract. 2020 Aug;16(8):e726-e733. doi: 10.1200/JOP.19.00509. Epub 2020 Mar 27.
- Background: PubMed 32970231Okado I, Pagano I, Cassel K, Holcombe RF. Perceptions of care coordination in cancer patient-family caregiver dyads. Support Care Cancer. 2021 May;29(5):2645-2652. doi: 10.1007/s00520-020-05764-8. Epub 2020 Sep 24.
- Individual participant dataSharing planned: Yes. Upon request, with removal of PHI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Table-based Educational Intervention in people with Cancer, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randall F Holcombe (18026563812, randall.holcombe@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Coordination Instrument Score (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723250, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.