- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00977834
Assessment of Older Adults With Cancer: Feasibility of Computer Survey Methodology
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Group 1
Patients with lymphoma or lung cancer
|
|
Group 2
Caregivers
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Feasibility of delivering the geriatric assessment via computer survey methodology.
Tidsram: Upon enrollment (one timepoint)
|
Upon enrollment (one timepoint)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
% of patients who do not enter the study and reason why
Tidsram: Upon enrollment (one timepoint)
|
Upon enrollment (one timepoint)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Arti Hurria, MD, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 08147
- P50CA107399-04 (U.S.S. NIH-anslag/kontrakt)
- K23AG026749-01 (U.S.S. NIH-anslag/kontrakt)
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