Improving Outcomes for Older Adults Undergoing Radiation Therapy: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •There is no exclusion criteria
结局指标
主要结局
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score Pre-RT
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Kavita Dharmarajan
Associate Professor of Radiation Oncology, Geriatrics, and Palliative Medicine
Icahn School of Medicine at Mount Sinai