Onco-primary Care Networking to Support TEAM-based Care (ONE TEAM)
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|ClinicalTrials.gov Identifier: NCT04258813|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 22, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Hypertension Cancer Cancer, Breast Cancer of Prostate Cancer Colorectal Cancer, Endometrial Cancer of Head and Neck Non Small Cell Lung Cancer CVD - Cardiovascular Disease Diabetes Mellitus Hypercholesterolemia Diabetes Cancer of Esophagus Cancer of Liver Cancer, Renal Cell Cancer of Pancreas Cancer Ovaries||Behavioral: iGuide Intervention (Self-guided) Behavioral: iGuide 2 Intervention (Tailored/Targeted) Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Investigators will use a SMART design with 2 randomizations - at the time of enrollment and after the 12-month measurement. At enrollment, participants will be cluster randomized to the self-guided multi-level iGuide intervention or control arm. An adaptive intervention will be used for the second randomization. PCP clinics in the intervention arm in which 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 12-month measurement will be considered 'non-responders' and randomized to a tailored/targeted intervention (iGuide2) or a control (iGuide).|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Onco-primary Care Networking to Support TEAM-based Care - the ONE TEAM Study|
|Actual Study Start Date :||June 14, 2021|
|Estimated Primary Completion Date :||March 31, 2024|
|Estimated Study Completion Date :||March 31, 2024|
40 PCP clinics; 400 patients
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.
Experimental: iGuide Intervention
40 PCP clinics; 400 patients
Behavioral: iGuide Intervention (Self-guided)
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.
Behavioral: iGuide 2 Intervention (Tailored/Targeted)
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.
- HEDIS quality measure of management hypertension [ Time Frame: 18 months ]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.
- HEDIS quality measure of management of diabetes [ Time Frame: 18 months ]A1c<8.0%. To evaluate diabetes management, the research team will measure fasting laboratory A1c at the time of each study assessment.
- HEDIS quality measure of management of statin use [ Time Frame: 18 months ]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.
- Patient-Centered Communication in Cancer Care [ Time Frame: 18 months ]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.
- Medication adherence [ Time Frame: 18 months ]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).
- Diversity supplement primary outcome: 90-day postoperative cardiovascular complications [ Time Frame: 90 days ]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.
- Medication adherence defined through patient self-report [ Time Frame: 18 months ]The investigators will use a self-report adherence measure created and validated by Voils et al which assesses extent of non-adherence as well as reasons for non-adherence. Participants will first respond to adherence items for each CVD comorbidity (n = 3 items each). Participants who are identified as non-adherent will be asked a series of medication-specific reasons for nonadherence (up to 18 items).
- Clinical laboratory values [ Time Frame: 18 months ]Comparison of A1c levels
- Clinical laboratory values [ Time Frame: 18 months ]Comparison of LDL-cholesterol levels
- Patient activation [ Time Frame: 18 months ]Patient activation will be assessed using the Patient Activation Measure (PAM), which is a 13-item measure that assesses a patient's knowledge, skills, and confidence that are central to managing health and health care. The PAM categorizes patients into four levels of activation: disengaged and overwhelmed (level 1), becoming aware but still struggling level 2), taking action (level 3), and maintaining behaviors and pushing further (level 4).
- Financial burden [ Time Frame: 18 months ]Patients' experience with cost of care (financial burden and objective cost) will be assessed through two self-reported measures of financial burden and actual expenditures. To assess financial burden, or financial toxicity, the research team will collect the Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity (COST). The FACIT-COST is an 11-item measure. The research team will also objectively ask patients about the amount of out-of-pocket expenditures for care over the last month via survey questions (e.g., insurance premiums, copayments, prescription medications, etc).
- Patient-reported care coordination [ Time Frame: 18 months ]Patient-reported care coordination will be collected using a 36-item measure developed by Haggerty et al. The measure contains 9 subscales that address team relational continuity, problems with coordination, gaps in information transfer, and patient's partnership in care.
- Provider-reported care coordination [ Time Frame: 18 months ]Provider-reported care coordination will be measured using companion clinician-reported measures, the Coordination of Specialty Care - Specialist Survey (n=13 items) and the Coordination of Specialty Care - Primary Care Survey (n=24 items). Both measures were developed by Vimalananda and colleagues, and include companion domains that facilitate descriptive comparisons across measures.The specialist version includes four domains (i.e., Relationships, Roles and Responsibilities,Communication, Data Transfer). The Roles and Responsibilities domain is broken into three domains in the primary care version (i.e., Role Clarity, Communication, Role Agreement, Making Referrals), resulting in a total of 6 factors.
- Risk index for cardiovascular complications [ Time Frame: 90 days ]Risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor
- PCP-reported care coordination [ Time Frame: 12 months ]PCPs who are participating in either the intervention or control arms of the ONE TEAM study will be invited to participate in a qualitative semi-structured interview guide assessing perspectives on (1) frequency, modes, and perceived quality of communication with surgical providers during transitions in care from surgery (2) perceived barriers to effective care coordination with surgical providers (3) how communication and care coordination can be improved.
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|Ages Eligible for Study:||18 Years to 79 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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)
- 18-79 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.
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258813
|Contact: Kevin C Oeffinger, MDfirstname.lastname@example.org|
|Contact: Leah Zullig, PhDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Kevin C Oeffinger, MD 919-668-2122 firstname.lastname@example.org|
|Contact: Leah Zullig, PhD 919-668-0300 email@example.com|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||February 6, 2020 Key Record Dates|
|Last Update Posted:||February 22, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Neoplasms
Carcinoma, Renal Cell
Glucose Metabolism Disorders
Endocrine System Diseases
Neoplasms by Site
Lipid Metabolism Disorders
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Genital Neoplasms, Male
Genital Diseases, Male