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Sädehoitoa saavien iäkkäiden aikuisten tulosten parantaminen

maanantai 21. syyskuuta 2026 päivittänyt: Kavita Dharmarajan, Icahn School of Medicine at Mount Sinai

Sädehoitoa saavien iäkkäiden aikuisten tulosten parantaminen: tuleva kohorttitutkimus

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.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

150

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • New York
      • New York, New York, Yhdysvallat, 10029
        • One Gustave L Levy Place

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

65 vuotta ja vanhemmat (Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Havaintomallit: COHORT
  • Aikanäkymät: PROSPECTIVE

Kohortit ja interventiot

Ryhmä/Kohortti
Older Adults in Radiation Therapy

Older Adults who are receiving Radiation Therapy.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Completion of Radiation Treatment
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Short Physical Performance Battery Score at Pre-RT
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Icahn School of Medicine at Mount Sinai

Yhteistyökumppanit

National Institute on Aging (NIA)

Tutkijat

  • Päätutkija: Kavita Dharmarajan, MD, MSc, Icahn School of Medicine at Mount Sinai

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

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Keskiviikko 9. marraskuuta 2022

Ensisijainen valmistuminen (Arvioitu)

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Opintojen valmistuminen (Arvioitu)

Sunnuntai 31. joulukuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 31. tammikuuta 2023

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 31. tammikuuta 2023

Ensimmäinen Lähetetty (Todellinen)

Torstai 9. helmikuuta 2023

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 24. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 21. syyskuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • GCO 19-2371
  • 1K76AG068516-01A1 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

There is no plan to share IPD data.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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