Assessing symptom burden and quality of life in cancer patients with heart failure
Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
This study is trying to see how cancer and heart failure symptoms affect the quality of life for patients who have both conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06656715 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate and compare the symptom burden experienced by cancer patients who also have heart failure, specifically those with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). Participants will undergo symptom assessments using the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF) and PROMIS instruments, focusing on fatigue, dyspnea, and sleep disturbance. Additionally, the study will assess health-related quality of life using the EORTC QLQ-C30 and the SF-12 questionnaires. The goal is to better understand the interplay between cancer and heart failure symptoms and their impact on patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a concurrent solid tumor cancer diagnosis who are not currently receiving active cancer treatment.
Not a fit: Patients undergoing active cancer treatment or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved management strategies for cancer patients suffering from heart failure.
How similar studies have performed: While there is limited data on studies specifically addressing this dual diagnosis, previous research has shown the importance of symptom management in cancer patients, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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: * Participants undergoing active cancer treatment. * Inability to provide consent in the medical record, such as cognitively impaired individuals.
Where this trial is running
Houston, Texas
- The University of Texas of MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Anceita Fadol, MSN,PHD,RN
- Email: afadol@mdanderson.org
- Phone: 832-817-8997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.