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