CancerNCT04765072
Expanding Rural Health Cancer Control Capacity
A study testing Survivorship Patient Navigation Intervention and Telehealth Survivorship Visit Intervention in people with Cancer, run by Debra Friedman at 4 sites in United States.
Trial summary
Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Survivorship Patient Navigation Intervention and Telehealth Survivorship Visit Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2021to Feb 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cancer patient at least 18 years of age at time of cancer therapy
- English-speaking with the ability to provide informed consent
- Received treatment for Stage 0 - III cancer with curative intent
- Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baptist Cancer Center- Bartlett
Bartlett, Tennessee, 38133
Baptist Cancer Center- Golden Triangle Columbus
Columbus, Mississippi, 39705
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Baptist Cancer Center - North Mississippi
Oxford, Mississippi, 38655
About this study
Official title: Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship
Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.
Read the detailed description
Study Aims:
- Pilot test the implementation of guideline-based survivorship care planning in a rural setting using patient navigation plus telehealth among underserved rural cancer survivors. Investigators will collect feasibility data on patient recruitment rates and the ability to measure clinical effectiveness outcomes using the electronic health record and patient reports (survivor adherence to recommended disease surveillance, health assessment and cancer prevention/early detection practices).
- Identify the facilitators and barriers to future larger scale implementation of guideline-based survivorship care planning in rural settings to optimize the implementation strategies. Through a mixed methods approach, investigators will address implementation research questions focused on "real world" implementation of the guideline-based intervention in rural areas, including barriers/facilitators and translation to other rural settings. This will allow us to optimize the implementation strategies that will be further evaluated in the future large-scale implementation trial
- Conditions
- Cancer
- Being tested
- Survivorship Patient Navigation Intervention, Telehealth Survivorship Visit Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Patient Navigation InterventionBehavioural
Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources
Telehealth Survivorship Visit InterventionBehavioural
Individualized survivorship care plan
| Study group | Role | What they receive |
|---|---|---|
| Survivorship care | Experimental | Participants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator. Receives: Behavioral: Survivorship Patient Navigation Intervention; Behavioral: Telehealth Survivorship Visit Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)
Measured: Approximately 12 months
Measure effectiveness of Telehealth on survivorship care
Measured: Approximately 12 months
Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
Measured: Approximately 1 year
Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start26 Feb 2021
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debra Friedman
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Debra Friedman, Vanderbilt-Ingram Cancer Center
- Investigators
- Debra Friedman, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765072
- Sponsor's protocol ID
- VICC PED 2019
- Other IDs
- 3P30CA068485-24S2
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship
- ClinicalTrials.gov ID
- NCT04765072
- Acronym / sponsor ID
- VICC PED 2019
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Debra FriedmanUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 21 Feb 2021 (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.
Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.
Detailed description
Study Aims:
- Pilot test the implementation of guideline-based survivorship care planning in a rural setting using patient navigation plus telehealth among underserved rural cancer survivors. Investigators will collect feasibility data on patient recruitment rates and the ability to measure clinical effectiveness outcomes using the electronic health record and patient reports (survivor adherence to recommended disease surveillance, health assessment and cancer prevention/early detection practices).
- Identify the facilitators and barriers to future larger scale implementation of guideline-based survivorship care planning in rural settings to optimize the implementation strategies. Through a mixed methods approach, investigators will address implementation research questions focused on "real world" implementation of the guideline-based intervention in rural areas, including barriers/facilitators and translation to other rural settings. This will allow us to optimize the implementation strategies that will be further evaluated in the future large-scale implementation trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivorship care | Experimental | Behavioral: Survivorship Patient Navigation Intervention, Behavioral: Telehealth Survivorship Visit InterventionParticipants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patient at least 18 years of age at time of cancer therapy
- English-speaking with the ability to provide informed consent
- Received treatment for Stage 0 - III cancer with curative intent
- Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Survivorship Patient Navigation InterventionPatient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources | Behavioural | Survivorship care |
| Telehealth Survivorship Visit InterventionIndividualized survivorship care plan | Behavioural | Survivorship care |
Primary outcome
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)
Time frame: Approximately 12 months
Measure effectiveness of Telehealth on survivorship care
Time frame: Approximately 12 months
Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
Time frame: Approximately 1 year
Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
Time frame: Approximately 1 year
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 15 Nov 2024.
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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. This study is not recruiting at the moment.
Debra Friedman, MD principal investigator
Vanderbilt-Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Patient Navigation Intervention and Telehealth Survivorship Visit Intervention in people with Cancer, run by Debra Friedman at 4 sites 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 4 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor) (time frame: Approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.