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Die klinische Studie NCT05721053 für KREBS, Strahlentherapie ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Improving Outcomes for Older Adults Undergoing Radiation Therapy 150
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Die klinische Studie NCT05721053 ist eine beobachtungsstudie zur Untersuchung von KREBS, Strahlentherapie und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 9. November 2022 und soll 150 Teilnehmer aufnehmen. Durchgeführt von Icahn School of Medicine at Mount Sinai ist der Abschluss für 30. Juni 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. Dezember 2025 aktualisiert.
Kurzbeschreibung
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 t...Mehr anzeigen
Offizieller Titel
Improving Outcomes for Older Adults Undergoing Radiation Therapy: Prospective Cohort Study
Erkrankungen
KREBSStrahlentherapieWeitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2022-11-09
Zuletzt aktualisiert
2025-12-17
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
150
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Older Adults in Radiation Therapy Older Adults who are receiving Radiation Therapy. | Nicht zutreffend |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Completion of Radiation Treatment | 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 | 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 | 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 | 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 | 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 | 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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Short Physical Performance Battery Score at Pre-RT | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Ältere Erwachsene
Mindestalter
65 Years
Zugelassene Geschlechter
Alle
- 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.
- There is no exclusion criteria
Verantwortliche Partei
Kavita Dharmarajan, Hauptprüfer, Associate Professor of Radiation Oncology, Geriatrics, and Palliative Medicine, Icahn School of Medicine at Mount Sinai
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
New York
One Gustave L Levy Place, New York, New York, 10029, United States