Improving Outcomes for Older Adults Undergoing Radiation Therapy

NCT05721053 | Active Not Recruiting

• 2 other identifiers: GCO 19-23711K76AG068516-01A1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Radiation Therapy

Outcome Measures

Primary Outcomes (6)

• Completion of Radiation Treatment

  The number of patients who have completed their radiation therapy (RT).

  at end of RT, average of 10 days

• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT

  EORTC-QLQ-30 Score consists of 30 items covered by 1 of 3 dimensions: * Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). * Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). * Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores are calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  pre-RT, time 0

• EORTC-QLQ-30 Score at Post-RT

  EORTC-QLQ-30 Score consists of 30 items covered by 1 of 3 dimensions: * Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). * Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). * Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores are calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  at end of RT, average of 10 days

• EORTC-QLQ-30 Score at 1 month follow-up

  EORTC-QLQ-30 Score at 1 month follow up. EORTC-QLQ-30 Score consists of 30 items covered by 1 of 3 dimensions: * Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). * Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). * Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores are calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  at 1 month follow-up

• EORTC-QLQ-30 Score at 3 months follow up

  EORTC-QLQ-30 Score at 3 months follow up. EORTC-QLQ-30 Score consists of 30 items covered by 1 of 3 dimensions: * Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). * Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). * Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores are calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  at 3 months follow-up

• EORTC-QLQ-30 Score at 6 months follow up

  EORTC-QLQ-30 Score at 6 months follow up. EORTC-QLQ-30 Score consists of 30 items covered by 1 of 3 dimensions: * Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent). * Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much). * Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much). All domain scores are calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.

  at 6 months follow-up

Secondary Outcomes (8)

• Short Physical Performance Battery Score at Pre-RT

  pre-RT, time 0

• Short Physical Performance Battery Score at at 1 month follow-up

  at 1 month follow-up

• Short Physical Performance Battery Score at 3 months follow-up

  at 3 months follow-up

• Short Physical Performance Battery Score at 6 months follow-up

  at 6 months follow-up

• Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score at Post-RT

  at end of RT, average of 10 days

Study Arms (1)

Older Adults in Radiation Therapy

Older Adults who are receiving Radiation Therapy.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

One Gustave L Levy Place

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kavita Dharmarajan, MD, MSc

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology, Geriatrics, and Palliative Medicine

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: November 9, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)