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

NCT06656715 | Recruiting

• 1 other identifier: 2024-1125
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SingleArm

Symptom Assessment and Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas of MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Anceita Fadol, MSN,PHD,RN

CONTACT

832-817-8997; afadol@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 24, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)