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Completed

NCT Number: NCT04836221

Comorbidities And Reducing inEquitieS

Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity.

Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Cancer Prostate Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Hypertension Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Black women with a diagnosis of stage 0-IV breast cancer and within a month of treatment initiation or with 6+ months of treatment left OR Black men with a history of prostate cancer who are on long-term androgen deprivation therapy;
  • Blood pressure >=120/80 OR diagnosis of diabetes
  • Individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted PI3K inhibitor therapies
  • Access to a smartphone and/or internet for the duration of the study.
  • Can understand and communicate in English

Exclusion criteria

  • Unwilling to participate in a 6-month study

Treatment and study plan

SUPPORT

Behavioral

Community Health Workers will conduct weekly phone calls to monitor blood pressure or blood glucose, to check in on patient need for social, practical or emotional supports, and to encourage healthy lifestyle modification.

Participants will also have access to a mobile app to support chronic disease management (Either diabetes or hypertension).

Primary outcomes

  1. Feasibility of study protocol

    Time frame: Study recruitment period will be approximately 12 months

    Accrual of >50 patients into the study

  2. Feasibility of an active management strategy for comorbidities

    Time frame: Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months)

    >80% recording blood pressure and/or blood glucose 3+ times per week

  3. Feasibility of an active management strategy for comorbidities

    Time frame: Study duration will be 6 months for prostate cancer patients and duration of treatment plus one month for breast cancer patients (approximately 7 months)

    >80% completion of weekly phone calls with community health workers

Secondary outcomes

  1. Provider perspectives on acceptability of active management of comorbidities

    Time frame: Beginning and end of study (approximately 18 months)

    >80% reporting agree to completely agree on the scale: Acceptability of Intervention Measure (FIM) measure.

Other outcomes

  1. Preliminary changes in self-efficacy

    Time frame: To be assess at baseline and end of study; approximately 6-7 months per participant

    PROMIS Self-Efficacy for Managing Chronic Conditions

  2. Preliminary changes in social support

    Time frame: To be assess at baseline and end of study; approximately 6-7 months per participant

    PROMIS Social Support

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Pfizer

Registry information

Official study title

Multi-level Interventions to Manage Co-morbidities Among Black Breast and Prostate Cancer Patients

Acronym: CARES

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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