Assessment of Frailty in Elderly Patients With Advanced Cancers (FAC-C)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome.
The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed using timed walk, grip strength and muscle mass measurement from imaging performed as part of routine clinical care.
The assessments will be performed at baseline, week 12 and week 24.
There is the option for patients to also donate blood samples for research purposes.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Newcastle upon Tyne, Storbritannia, NE7 7DN
- Newcastle upon Tyne NHS Trust
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Histological diagnosis of advanced carcinoma - not suitable for curative treatment
- Age 70 years or over
- seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made
- WHO Performance Status 0-2
- Written informed consent
Exclusion Criteria:
- Hepatocellular cancer
- Prostate cancer
- Breast cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage patients consenting for assessments out of number approached
Tidsramme: Baseline
|
Number of patients consenting for the study as a percentage of number of patients approached about the study.
|
Baseline
|
|
Time taken to complete assessments
Tidsramme: Baseline, week 12 and week 24
|
Length of time participants take to complete study assessments
|
Baseline, week 12 and week 24
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frailty as a predictor of grade 3/4 toxicity
Tidsramme: baseline
|
Evaluate whether there is a possible correlation between frailty score at baseline and development of grade 3/4 toxicity during anticancer treatment
|
baseline
|
|
Sarcopenia as a predictor of outcome
Tidsramme: baseline, week 12 and week 24
|
sarcopenia at baseline and over time as a predictor of outcome
|
baseline, week 12 and week 24
|
|
Quality of life EORTC QCQ 30
Tidsramme: baseline, week 12 and week 24
|
Participants complete EORTC QCQ 30 questionnaire
|
baseline, week 12 and week 24
|
|
Biomarker assessment of frailty and associated factors which may include genetic analysis
Tidsramme: baseline, week 12 and week 24
|
Assessment of frailty biomarkers in blood samples
|
baseline, week 12 and week 24
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alastair Greystoke, MRCP, PhD, MBChB, MSc, Newcastle University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6731
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