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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anceita Fadol, MSN,PHD,RN; Phone Number: 832-817-8997; Email: afadol@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas of MD Anderson Cancer Center
      • Contact: Anecita P Fadol, MSN,PHD,RN; Phone Number: 832-817-8997; Email: afadol@mdanderson.org
      • Principal Investigator: Anecita P Fadol, MSN,PHD,RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

We will approach cancer participants with solid tumors and with a concurrent diagnosis of heart failure who are followed at MD Anderson for HF management. In fiscal year 2023, of the more than 20,000 hospital discharges, approximately 6% of those discharges have a concurrent diagnosis of heart failure. Investigators will enroll 100 participants who meet the inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SingleArm; Symptom Assessment and Comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure	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).	Through study completion, an average of 3 years
Heart Failure	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).	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2024-1125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No