New study aims to help cancer survivors manage other health problems
NCT ID NCT04258813
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way for cancer doctors and primary care doctors to work together to help cancer survivors manage other health problems like high blood pressure, diabetes, and high cholesterol. About 800 adults with certain cancers and at least one of these conditions will take part. The goal is to see if better teamwork between doctors leads to improved health and communication for survivors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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313 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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