Clinical trial · Observational
Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
NCT06656715CI-TRIAL-00117830active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- SingleArm
- description
- Symptom Assessment and Comparison
Primary outcomes (2)
- measure
- Heart Failure
- timeFrame
- Through study completion, an average of 3 years
- 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).
- measure
- Heart Failure
- timeFrame
- Through study completion, an average of 3 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.