Improving Outcomes for Older Adults Undergoing Radiation Therapy

Cancer Clinical Trial

Official title:

Improving Outcomes for Older Adults Undergoing Radiation Therapy: Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721053
• Other study ID #: GCO 19-2371
• Secondary ID: 1K76AG068516-01A
• Status: Recruiting
• Start date: November 9, 2022
• Est. completion date: May 2026

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Kavita Dharmarajan, MD, MSc
• Phone: (646) 605-5841
• Email: kavita.dharmarajan[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Radiation Therapy

Locations

Country	Name	City	State
United States	One Gustave L Levy Place	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Radiation Treatment	The number of patients who have completed their radiation therapy (RT).	at end of RT, average of 10 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Short Physical Performance Battery Score at Pre-RT	Physical performance pre-RT, measured by the Short Physical Performance Battery (SPPB), a 10-minute provider-administered test of balance, 4-meter walk, and chair stands, which predicts disability and mortality in older adults and cancer patients. Each of the 3 tests are scored from 0-4 and summed for a total scale range of 0-12, with higher scores indicating better physical function.	pre-RT, time 0
Secondary	Short Physical Performance Battery Score at at 1 month follow-up	Physical performance at 1 month follow-up, measured by the Short Physical Performance Battery (SPPB), a 10-minute provider-administered test of balance, 4-meter walk, and chair stands, which predicts disability and mortality in older adults and cancer patients. Each of the 3 tests are scored from 0-4 and summed for a total scale range of 0-12, with higher scores indicating better physical function.	at 1 month follow-up
Secondary	Short Physical Performance Battery Score at 3 months follow-up	Physical performance at 3 month follow-up, measured by the Short Physical Performance Battery (SPPB), a 10-minute provider-administered test of balance, 4-meter walk, and chair stands, which predicts disability and mortality in older adults and cancer patients. Each of the 3 tests are scored from 0-4 and summed for a total scale range of 0-12, with higher scores indicating better physical function.	at 3 months follow-up
Secondary	Short Physical Performance Battery Score at 6 months follow-up	Physical performance at 6 months follow-up, measured by the Short Physical Performance Battery (SPPB), a 10-minute provider-administered test of balance, 4-meter walk, and chair stands, which predicts disability and mortality in older adults and cancer patients. Each of the 3 tests are scored from 0-4 and summed for a total scale range of 0-12, with higher scores indicating better physical function.	at 6 months follow-up
Secondary	Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score at Post-RT	Patient reported toxicity outcomes as measured using the PRO-CTCAE scale at post-RT. The PRO-CTCAE is a 5-minute survey, integrating patient perspectives into clinicians' reporting of treatment toxicity. It is validated for use in medical and radiation oncology and has revealed clinician underreporting of toxicity severity in older patients. The survey is scored on a 0-5-point scale, where higher outcomes indicate worse health outcomes.	at end of RT, average of 10 days
Secondary	PRO-CTCAE Score at 1 month follow-up	Patient reported toxicity outcomes as measured using the PRO-CTCAE scale at 1 month follow-up. The PRO-CTCAE is a 5-minute survey, integrating patient perspectives into clinicians' reporting of treatment toxicity. It is validated for use in medical and radiation oncology and has revealed clinician underreporting of toxicity severity in older patients. The survey is scored on a 0-5-point scale, where higher outcomes indicate worse health outcomes.	at 1 month follow-up
Secondary	PRO-CTCAE Score at 3 months follow-up	Patient reported toxicity outcomes as measured using the PRO-CTCAE scale at 3 months follow-up. The PRO-CTCAE is a 5-minute survey, integrating patient perspectives into clinicians' reporting of treatment toxicity. It is validated for use in medical and radiation oncology and has revealed clinician underreporting of toxicity severity in older patients. The survey is scored on a 0-5-point scale, where higher outcomes indicate worse health outcomes.	at 3 months follow-up
Secondary	PRO-CTCAE Score at 6 months follow-up	Patient reported toxicity outcomes as measured using the PRO-CTCAE scale at 6 months follow-up. The PRO-CTCAE is a 5-minute survey, integrating patient perspectives into clinicians' reporting of treatment toxicity. It is validated for use in medical and radiation oncology and has revealed clinician underreporting of toxicity severity in older patients. The survey is scored on a 0-5-point scale, where higher outcomes indicate worse health outcomes.	at 6 months follow-up