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Active, not recruitingNCT06656715Updated Jul 14, 2026

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

An observational study in Heart Failure, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 102 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • SingleArm

    Symptom Assessment and Comparison

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Through study completion, an average of 3 years

  2. 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).

    Time frame: Through study completion, an average of 3 years

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Study locations

1 site
  • The University of Texas of MD Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06656715
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Oct 24, 2024
Start date
Dec 16, 2024
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jul 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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