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Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT06656715
2024-1125

Details and patient eligibility

About

To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).

Full description

The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).

The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 years and older
  • Individuals with a concurrent solid tumor cancer diagnosis
  • Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)[Tamoxifen], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists [Leuprolide], Androgen deprivation therapy for prostate cancer
  • Completed cancer treatment at least 3 months and up to 3 years before study enrollment.

Therapy

  • Able to read, speak and consent in English
  • Ability to understand and the willingness to sign a written informed consent document
  • Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization
  • Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.

Exclusion criteria

  • Participants undergoing active cancer treatment.
  • Inability to provide consent in the medical record, such as cognitively impaired individuals.

Trial design

100 participants in 1 patient group

SingleArm
Description:
Symptom Assessment and Comparison

Trial contacts and locations

1

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Central trial contact

Anceita Fadol, MSN,PHD,RN

Data sourced from clinicaltrials.gov

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