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放射線治療を受けている高齢者の治療成績を改善する

2026年9月21日 更新者：Kavita Dharmarajan、Icahn School of Medicine at Mount Sinai

放射線治療を受けている高齢者の転帰の改善：前向きコホート研究

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.

調査の概要

状態

積極的、募集していない

条件

研究の種類

観察的

入学 (実際)

150

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • New York
      • New York、New York、アメリカ、10029
        • One Gustave L Levy Place

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
Older Adults in Radiation Therapy

Older Adults who are receiving Radiation Therapy.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Completion of Radiation Treatment
時間枠：at end of RT, average of 10 days

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
時間枠：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.
pre-RT, time 0
EORTC-QLQ-30 Score at Post-RT
時間枠：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.
at end of RT, average of 10 days
EORTC-QLQ-30 Score at 1 month follow-up
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Short Physical Performance Battery Score at Pre-RT
時間枠：pre-RT, time 0

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
Short Physical Performance Battery Score at at 1 month follow-up
時間枠：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
Short Physical Performance Battery Score at 3 months follow-up
時間枠：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
Short Physical Performance Battery Score at 6 months follow-up
時間枠：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
Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) Score at Post-RT
時間枠：at end of RT, average of 10 days

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
PRO-CTCAE Score at 1 month follow-up
時間枠：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
PRO-CTCAE Score at 3 months follow-up
時間枠：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
PRO-CTCAE Score at 6 months follow-up
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Icahn School of Medicine at Mount Sinai

協力者

National Institute on Aging (NIA)

捜査官

  • 主任研究者：Kavita Dharmarajan, MD, MSc、Icahn School of Medicine at Mount Sinai

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年11月9日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2023年1月31日

QC基準を満たした最初の提出物

2023年1月31日

最初の投稿 (実際)

2023年2月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • GCO 19-2371
  • 1K76AG068516-01A1 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

There is no plan to share IPD data.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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