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

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06656715
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Study Start: 2024-12-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure	Through study completion, an average of 3 years	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).

Trial Locations

Locations (1)

The University of Texas of MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States