Radiation Adherence/Toxicity in Patients With Non-Ovarian Gynecological Cancers
22. januar 2018 opdateret af: UNC Lineberger Comprehensive Cancer Center
Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers.
A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues.
Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
15
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Department of Radiation Oncology Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients age 18 years of age or above with a diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment with curative intent at the Department of Radiation Oncology at UNC Chapel Hill.
Beskrivelse
Inclusion Criteria:
- ≥Age 18 years (no upper age limit)
- Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill
- Ability to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist
- Negative serum pregnancy test in women of childbearing potential
Exclusion Criteria:
- < Age 18 years
- Incurable cancer as defined by their radiation oncologist
- Planned radiation for palliative intent only
- Inability to complete the I-ADL section of the CGA
- Prior radiation to areas targeted by radiotherapy within this study
- Other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of:
- Localized squamous cell carcinoma of the skin
- Basal-cell carcinoma of the skin
- Other malignancies requiring locally ablative therapy only
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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≥65 years old
20 patients greater than or equal to 65 years of age
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<65 years old
20 patients less than 65 years of age
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pre-treatment I-ADL dependency
Tidsramme: Pre-treatment
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Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
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Pre-treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Poor adherence to treatment
Tidsramme: During or 4-8 weeks post-treatment
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Poor adherence to treatment is defined by at least one of the following:
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During or 4-8 weeks post-treatment
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient-reported acute grade 3-5 radiation related toxicities
Tidsramme: During treatment and 4-8 weeks post-treatment
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Patient-reported acute grade 3-5 radiation related toxicities will be based on the PRO-CTCAE questionnaire during and 4-8 weeks post radiation therapy and at 6 months.
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During treatment and 4-8 weeks post-treatment
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Provider-reported grade 3-5 acute radiation related toxicities
Tidsramme: During treatment and 4-8 weeks post-treatment
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Provider-reported grade 3-5 acute radiation related toxicities will be based on the CTCAE (Common Toxicity Criteria for Adverse Effects) v4.03 during and 4-8 weeks post radiation therapy
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During treatment and 4-8 weeks post-treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Mahesh Varia, MD, ChB, Department of Radiation Oncology, University of North Carolina Chapel Hill
- Studieleder: Noam VanderWalde, MD, Department of Radiation Oncology, Unverisity of North Carolina Chapel Hill
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2013
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. oktober 2017
Datoer for studieregistrering
Først indsendt
18. november 2013
Først indsendt, der opfyldte QC-kriterier
2. december 2013
Først opslået (Skøn)
6. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- LCCC1321
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .