- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00977834
Assessment of Older Adults With Cancer: Feasibility of Computer Survey Methodology
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Patients older than age 65, in comparison to those younger than 65, have an 11-fold increased cancer incidence and a 16-fold increase in cancer mortality. The population at risk is growing rapidly: the number of adults age 65 and older is expected to double in the next 30 years. In order to adequately care for this growing population of older adults, oncologists need an assessment tool that provides information regarding an older individual's "functional age" in comparison to their "chronological age." The technology of geriatric assessment could potentially help identify those older adults who are more vulnerable to complications from cancer treatment. This inter-disciplinary assessment provides information regarding the patient's functional status, comorbid medical conditions, other medications, nutritional status, psychological state, social support, and cognition.
Hurria and colleagues developed a geriatric assessment for older adults with cancer, which includes well validated measures of functional status, comorbid medical conditions, nutritional status, psychological state, cognitive function, social activity, and social support. Pilot data demonstrates the feasibility of this assessment which can be completed in less than 30 minutes; however, this assessment is completed by "pencil and paper" and requires an interviewer to deliver and score the assessment.
Loscalzo, Clark, and colleagues have developed a computer methodology in order to assess the needs of patients with cancer of all ages. The assessment is completed by the patients and a scoring algorithm is developed to provide a summary of the patient's needs for the healthcare team. This assessment is highly successful at identifying the needs of patients of all ages.
In this protocol, we will merge the research interests of Hurria, Loscalzo, and Clark by developing a computer survey program to capture the physical and psychological needs of older adults with cancer. The goal of this study is to evaluate the feasibility of computer survey methodology among older adults with cancer. For the purposes of this protocol we will accrue patients with lymphoma and lung cancer.
Schema:
- Identify an older adult (age 65 and older) with lymphoma or lung cancer.
- Describe the study to the patient: patient consents or refuses.
- Consenting patients complete the geriatric assessment via a computer survey.
- The following feasibility data will be captured: length of time to complete the assessment, patient's need for assistance to complete the assessment, satisfaction with the use of computer survey methodology to complete the assessment.
- The primary caretaker (if available) will be invited to participate in the protocol and complete a caregiver's survey of the patient's needs and questions about caregiver burden.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
California
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Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients must be > age of 65
- Diagnosis of lymphoma or lung cancer
- Be able to provide informed consent
Exclusion Criteria:
- Not fluent in English (because not all questionnaires have been validated in other languages)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Group 1
Patients with lymphoma or lung cancer
|
|
Group 2
Caregivers
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Feasibility of delivering the geriatric assessment via computer survey methodology.
Tidsramme: Upon enrollment (one timepoint)
|
Upon enrollment (one timepoint)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
% of patients who do not enter the study and reason why
Tidsramme: Upon enrollment (one timepoint)
|
Upon enrollment (one timepoint)
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Arti Hurria, MD, City of Hope Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 08147
- P50CA107399-04 (U.S. NIH-bevilling/kontrakt)
- K23AG026749-01 (U.S. NIH-bevilling/kontrakt)
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