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Trial Title:
Improving Outcomes for Older Adults Undergoing Radiation Therapy
NCT ID:
NCT05721053
Condition:
Cancer
Radiation Therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The purpose of this study is to improve healthcare received by people ≥ 65 years who are
receiving radiation therapy (RT). The study will primarily examine patients ability to
complete RT, changes in a patients' daily function and self-reported toxicities. To
collect this information, study participants will be asked to complete surveys and
physical and cognitive function assessments at five different timepoints in their
treatment: before RT, End of RT, and at 1, 3, and 6 months follow up visits. Findings of
this study will help radiation oncologists make more informed decisions for future
patients receiving RT.
Criteria for eligibility:
Study pop:
All participants presenting to Mount Sinai Hospital, Mount Sinai Downtown, and Mount
Sinai West who meet eligibility criteria will be given the option of participating. The
hospitals serve distinct regions of New York City with diverse sociodemographic
characteristics. All have RT services for ambulatory and hospitalized patients.
The total number of study enrollments at Mount Sinai Hospital, Mount Sinai Downtown, and
Mount Sinai West twill be approximately 225 over 36 months.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient must be ≥ 65 years
- Patient must have pathologically confirmed cancer
- Patient must have the ability to provide informed consent, or have a legally
authorized representative (LAR) present to provide informed consent on the
participant's behalf
- Must be radiation oncology patient at Mount Sinai Hospital, Mount Sinai Downtown, or
Mount Sinai West.
Exclusion Criteria:
- There is no exclusion criteria
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
One Gustave L Levy Place
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Kavita Dharmarajan
Email:
Principal Investigator
Start date:
November 9, 2022
Completion date:
May 2026
Lead sponsor:
Agency:
Icahn School of Medicine at Mount Sinai
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
Icahn School of Medicine at Mount Sinai
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721053