Clinical trial NCT05721053: Improving Outcomes for Older Adults Undergoing Radiation Therapy
Official title: Improving Outcomes for Older Adults Undergoing Radiation Therapy: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Radiation Therapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-02-09
Enrollment: 225
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Completion of Radiation Treatment
timeFrame: at end of RT, average of 10 days
measure: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT
timeFrame: pre-RT, time 0
measure: EORTC-QLQ-30 Score at Post-RT
timeFrame: at end of RT, average of 10 days
measure: EORTC-QLQ-30 Score at 1 month follow-up
timeFrame: at 1 month follow-up
measure: EORTC-QLQ-30 Score at 3 months follow up
timeFrame: at 3 months follow-up
measure: EORTC-QLQ-30 Score at 6 months follow up
timeFrame: at 6 months follow-up
Secondary outcomes:
measure: Short Physical Performance Battery Score at Pre-RT
timeFrame: pre-RT, time 0
measure: Short Physical Performance Battery Score at at 1 month follow-up
timeFrame: at 1 month follow-up
measure: Short Physical Performance Battery Score at 3 months follow-up
timeFrame: at 3 months follow-up
measure: Short Physical Performance Battery Score at 6 months follow-up
timeFrame: at 6 months follow-up
measure: Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score at Post-RT
timeFrame: at end of RT, average of 10 days
measure: PRO-CTCAE Score at 1 month follow-up
timeFrame: at 1 month follow-up
measure: PRO-CTCAE Score at 3 months follow-up
timeFrame: at 3 months follow-up
measure: PRO-CTCAE Score at 6 months follow-up
timeFrame: at 6 months follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: One Gustave L Levy Place
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Kavita Dharmarajan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: