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

NCT ID: NCT06656715

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-16

Study Completion Date

2028-09-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SingleArm

Symptom Assessment and Comparison

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Texas of MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anceita Fadol, MSN,PHD,RN

Role: CONTACT

Phone: 832-817-8997

Email: [email protected]

Facility Contacts

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Anecita P Fadol, MSN,PHD,RN

Role: primary

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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2024-1125

Identifier Type: -

Identifier Source: org_study_id