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

NCT06656715 · M.D. Anderson Cancer Center
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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).
Eligibility criteria
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.
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-12-16
Estimated completion: 2028-09-01
Last updated: 2025-12-23
Primary outcomes
  • Heart Failure (Through study completion, an average of 3 years)
  • Heart Failure (Through study completion, an average of 3 years)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactAnceita Fadol, MSN,PHD,RN · contact · afadol@mdanderson.org · 832-817-8997
All locations (1)
The University of Texas of MD Anderson Cancer CenterRecruiting
Houston, Texas, United States