Breast CancerRESOURCENCT04879927
Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
A study testing Resource Matching in people with Breast Cancer and Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Gastrointestinal Cancer
- What is being tested?
- Resource Matching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in DFCI BOC, TOP or GCC. To select for patients from demographic groups vulnerable to SDoH needs, two different groups will be eligible to participate.
- Group A
- BIPOC (Black, Latinx, Native American or Pacific Islander)
- LEP Spanish-speaking (As indicated by the EHR)
- Low SES (from zip code with median household income <$32,000/year) OR
- Age 70+
Show all 9Show fewer
- Group B
- Any one NPIQ response indicating SDoH need
- Health literacy/numeracy, Caregiving/relationships, OR Finances
Who cannot join
- Group A and B
- -- Patients not continuing care at Dana Farber Cancer Institute
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.
Read the detailed description
This research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at Dana-Farber Cancer Institute.
- The research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching.
- Participants will be randomized into one of two groups.
- Usual Care or Usual Care with customized resource matching.
It is expected that about 125 participants will take part in this research study.
- Conditions
- Breast Cancer, Lung Cancer, Gastrointestinal Cancer
- Being tested
- Resource Matching, Usual Care
- Keywords
- Breast Cancer, Lung Cancer, Gastrointestinal Cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource MatchingOther
Resource staff involved in the customized resource matching arm of the intervention will include staff from DFCI Patient Services and DFCI Financial Counseling. Financial counseling will support patients with financial resource needs. DFCI Patient Services will provide assistance for all other patient Social Determinants of Health needs.
Usual CareOther
Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.
| Study group | Role | What they receive |
|---|---|---|
| RESOURCE Matching | Experimental | Participants randomized into the intervention arm will receive customized resource matching Receives: Other: Resource Matching |
| Usual Care | Active comparator | Participants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Treatment Interruption
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 30 Days
Number of Patients Treatment Interruption
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 90 Days
Number of Patients Treatment Interruption
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 180 Days
Rate of Treatment Interruption
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 00 Days
Rate of Treatment Interruption
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 90 Days
Rate of Treatment Interruption
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start17 May 2021
- Primary completion1 Oct 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine McCleary, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Nadine J. McCleary, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879927
- Sponsor's protocol ID
- 20-437
- Acronym
- RESOURCE
- Status last verified
- May 2023
- First submitted
- 5 May 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement
- ClinicalTrials.gov ID
- NCT04879927
- Acronym / sponsor ID
- RESOURCE / 20-437
- Conditions
- Breast Cancer, Lung Cancer, Gastrointestinal Cancer
- Keywords
- Breast Cancer, Lung Cancer, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 10 May 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.
The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.
Detailed description
This research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at Dana-Farber Cancer Institute.
- The research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching.
- Participants will be randomized into one of two groups.
- Usual Care or Usual Care with customized resource matching.
It is expected that about 125 participants will take part in this research study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESOURCE Matching | Experimental | Other: Resource MatchingParticipants randomized into the intervention arm will receive customized resource matching |
| Usual Care | Active comparator | Other: Usual CareParticipants randomized into the control group will receive a pre-existing pamphlet detailing DFCI resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in DFCI BOC, TOP or GCC. To select for patients from demographic groups vulnerable to SDoH needs, two different groups will be eligible to participate.
- Group A
- Group B
Key exclusion criteria (2 listed)
- Group A and B
- -- Patients not continuing care at Dana Farber Cancer Institute
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 |
|---|---|---|
| Resource MatchingResource staff involved in the customized resource matching arm of the intervention will include staff from DFCI Patient Services and DFCI Financial Counseling. Financial counseling will support patients with financial resource needs. DFCI Patient Services will provide assistance for all other patient Social Determinants of Health needs. | Other | RESOURCE Matching |
| Usual CarePatients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources. | Other | Usual Care |
Primary outcome
Number of Patients Treatment Interruption
Time frame: 30 Days
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Number of Patients Treatment Interruption
Time frame: 90 Days
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Number of Patients Treatment Interruption
Time frame: 180 Days
Number of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Rate of Treatment Interruption
Time frame: 00 Days
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Rate of Treatment Interruption
Time frame: 90 Days
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Rate of Treatment Interruption
Time frame: 180 Days
Rate of interruptions to cancer treatment (defined here as treatment hold, reduction, discontinuation or ED visits/hospitalizations as indicated by the patient medical record)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Nadine J. McCleary, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resource Matching in people with Breast Cancer and Lung Cancer, run by Dana-Farber Cancer Institute 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients Treatment Interruption (time frame: 30 Days). The study lists 6 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 3 May 2023.