Improving Outcomes for Older Adults Undergoing Radiation Therapy: Prospective Cohort Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Kavita Dharmarajan
Associate Professor of Radiation Oncology, Geriatrics, and Palliative Medicine
Icahn School of Medicine at Mount Sinai
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
Outcomes
Primary Outcomes
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT
Time Frame: pre-RT, time 0
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.
Completion of Radiation Treatment
Time Frame: at end of RT, average of 10 days
The number of patients who have completed their radiation therapy (RT).
EORTC-QLQ-30 Score at Post-RT
Time Frame: at end of RT, average of 10 days
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.
EORTC-QLQ-30 Score at 1 month follow-up
Time Frame: 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.
EORTC-QLQ-30 Score at 3 months follow up
Time Frame: 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.
EORTC-QLQ-30 Score at 6 months follow up
Time Frame: 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.
Secondary Outcomes
- PRO-CTCAE Score at 3 months follow-up(at 3 months 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)
- 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)
- 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)
- PRO-CTCAE Score at 1 month follow-up(at 1 month follow-up)
- PRO-CTCAE Score at 6 months follow-up(at 6 months follow-up)