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Verbetering van de resultaten voor oudere volwassenen die bestralingstherapie ondergaan

21 september 2026 bijgewerkt door: Kavita Dharmarajan, Icahn School of Medicine at Mount Sinai

Verbetering van de resultaten voor oudere volwassenen die radiotherapie ondergaan: prospectieve cohortstudie

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- New York
  - New York, New York, Verenigde Staten, 10029
    - One Gustave L Levy Place

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: COHORT
Tijdsperspectieven: PROSPECTIVE

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Older Adults in Radiation Therapy Older Adults who are receiving Radiation Therapy.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Completion of Radiation Treatment Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Short Physical Performance Battery Score at Pre-RT Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Icahn School of Medicine at Mount Sinai

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 november 2022

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

31 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

31 januari 2023

Eerst geplaatst (Werkelijk)

9 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Neoplasmata

Andere studie-ID-nummers

GCO 19-2371
1K76AG068516-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to share IPD data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .