Onco-primary Care Networking to Support TEAM-based Care
ONE TEAM
1 other identifier
interventional
313
1 country
1
Brief Summary
The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
February 20, 2026
February 1, 2026
5.1 years
January 23, 2020
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
HEDIS quality measure of management hypertension
BP\<140/90 mmHg. Rather than use vital sign BP readings, which tend to have much variation, the research staff will measure the BP at the above time periods. The investigators will assess BP consistent with the TRUE Consortium standards.
18 months
HEDIS quality measure of management of diabetes
A1c\<8.0%. To evaluate diabetes management, the research team will measure fasting laboratory A1c at the time of each study assessment.
18 months
HEDIS quality measure of management of statin use
Statin use if patient is diabetic or has a 10-year ASCVD risk \>10%. To evaluate statin use, the research team will measure fasting laboratory lipid profile at the time of each study assessment.
18 months
Patient-Centered Communication in Cancer Care
Patient-reported Patient-Centered Communication in Cancer Care (PCC-Ca-36). The PCC-Ca-36 is a 36-item survey that measures one overall communication score, and six sub-domains that are consistent with our conceptual models:exchanging information, making decisions,fostering healing relationships, enabling patient self-management, managing uncertainty, and responding to emotions.
18 months
Medication adherence
Medication adherence will be measured as proportion of days covered, and the research team will obtain pharmacy refill data from the EHR. For participants followed by a Duke PCP, all refills (including refill date, amount, number of refills) are captured in Epic. For PCPs outside of Duke, the research team will use the Epic link with Surescripts which captures e-prescribed medications. Using this data, the investigators will calculate the PDC for an index medication from each medication class for the three CVD comorbidities, depending upon the number of CVD comorbidities a participant has. PDC is a measure of how many days a patient is in possession of their medication, calculated as the total number of days in a followup period divided by the total number of days that a medication was available (ratio of the number of days the patient is covered by a medication during a refill period).
18 months
Diversity supplement primary outcome: 90-day postoperative cardiovascular complications
any occurrence of myocardial infarction, stroke, venous thromboembolism (deep venous thrombosis, pulmonary embolism), new-onset atrial fibrillation, heart failure or cardiopulmonary arrest within 90 days of surgery tracked with ICD codes.
90 days
Secondary Outcomes (7)
Medication adherence defined through patient self-report
18 months
Clinical laboratory values
18 months
Clinical laboratory values
18 months
Patient activation
18 months
Financial burden
18 months
- +2 more secondary outcomes
Other Outcomes (2)
Risk index for cardiovascular complications
90 days
PCP-reported care coordination
12 months
Study Arms (2)
Control
EXPERIMENTAL40 PCP clinics; 400 patients
iGuide Intervention
EXPERIMENTAL40 PCP clinics; 400 patients
Interventions
The iGuide Intervention consists of two patient-level and four PCP-level components. These components include: (1) the patient-level brief video vignettes with a written summary; and (2) patient-facing webinars. The investigators will not use any institutional branding in the videos, printed materials, or recorded webinars so that these deliverables can be used in other settings.
The iGuide2 patient-level intervention will use a stage-based, tailored approach to four monthly 5-minute video vignettes that incorporates a pre-video worksheet. The investigators will send the worksheets and video vignettes in the method preferred by the patient. The targeted iGuide 2 PCP-level intervention will include a cancer specialist-facing dashboard that includes the specialists's patients who are enrolled in the study and are in the intervention arm. The HEDIS quality measures for our three CVD comorbidities will be used. The dashboard will be populated with data available in Epic for the specific patient. If some information is missing (i.e., there is no lipid profile in the laboratory tab), the dashboard will query the PCP via an e-consult, asking to supply the information. Bimonthly, starting with the second randomization, an asynchronous specialist-to-PCP e-consult will be sent to PCPs whose patient(s) do not meet all three of the HEDIS quality metrics.
Participants randomized to the control group (n=400) will receive current guideline-concordant cancer care. The investigators will also provide information for healthy living during and after cancer and for preparing for transition from cancer therapy to follow-up care. Monthly, patient education material on healthy living will be sent to the participants via the patient portal or by mail, based on participant preference. At the completion of therapy, they will be provided the NCI Facing Forward:Life After Cancer booklet. Note, this approach is not fully equivalent to an attention control as there will be touch points in the iGuide and iGuide2 interventions that the investigators cannot match for the control group. Also, the research team will not engage the PCPs in clinics randomized to the control group.
Eligibility Criteria
You may qualify if:
- A total of 800 individuals who fall under the following criteria will be enrolled:
- Diagnosed with -
- Stage I-III breast \[female\], colorectal, endometrial (carcinomas), head/neck \[H/N\] and non-small cell lung cancer \[NSCLC\]
- Stage I-IV prostate cancer
- Organ transplant recipients are not excluded as long as kidney function is within eligible range
- Chronic Lymphocytic Leukemia or small lymphocytic lymphoma on first or second line treatment
- Treated with curative intent (not applicable for patients diagnosed with CLL/SLL)
- years old
- Has at least one of three CVD comorbidities (hypertension, diabetes, or hypercholesterolemia) - based upon whether the patient is currently on a medication for the comorbidity at time of recruitment
- Had a visit with their PCP in the previous 12 months
- Patients will be approached for study participation within 120 days of starting their cancer treatment at Duke (except for men with prostate cancer on androgen deprivation therapy \[ADT\] and those previously on active surveillance). Those coming off active surveillance to receive treatment will be approached within the next 120 days. Men with prostate cancer that are on ADT can be approached for consent at any time while on treatment.
- Supplement:
- A sample size of 2800-3000 patients will be pulled from the Duke Cancer Registry. The retrospective cohort will consist of older adults ≥65 years who have ≥1 CVD comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors (breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer) at DUHS from January 1st, 2017 to December 31st 2019.
- The qualitative component of the supplement (Appendix IV: Aim 3) will involve 12-20 PCPs who arepart of the Duke Primary Care Research Consortium. Eligible PCP participants will be English-speaking providers who have provided care to ≥1 older adult patient who has undergone cancer surgery within a 12-month period at DUHS.
You may not qualify if:
- Individuals with a history of the following conditions will be ineligible:
- Myocardial infarction in the previous 24 months
- Stage III-IV heart failure (EF \<30%)
- Stage IV-V chronic kidney disease (eGFR \<30)
- Neuroendocrine tumors
- Uterine sarcomas
- Bilateral axillary dissections - due to the inability to collect an upper extremity BP
- Patients who are coming to Duke for surgery only and not planning to return are ineligible. Patients who cannot read, are blind or do not understand/speak English will not be enrolled.
- Participants who progress to metastatic disease during the course of the 18-month study period will be allowed to continue to participate unless they voluntarily withdraw from the study.
- Additional health information may be assessed on a case by case basis by the PI to determine if the individual is an appropriate candidate for the intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Zullig LL, Shahsahebi M, Neely B, Hyslop T, Avecilla RAV, Griffin BM, Clayton-Stiglbauer K, Coles T, Owen L, Reeve BB, Shah K, Shelby RA, Sutton L, Dinan MA, Zafar SY, Shah NP, Dent S, Oeffinger KC. Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial. BMC Fam Pract. 2021 Nov 18;22(1):234. doi: 10.1186/s12875-021-01569-8.
PMID: 34794388DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
February 6, 2020
Study Start
June 14, 2021
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share