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| Sponsor: | Ziekenhuis Netwerk Antwerpen Middelheim |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01005693 |
Purpose
RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.
| Condition | Intervention |
|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Unspecified Adult Solid Tumor, Protocol Specific |
Drug: chemotherapy Other: questionnaire administration Procedure: cognitive assessment Procedure: examination Procedure: management of therapy complications |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.
Patients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Belgium | |
| Onze Lieve Vrouw Ziekenhuis Aalst | Recruiting |
| Aalst, Belgium, B-9300 | |
| Contact: Contact Person Not Available | |
| Virga Jesse Hospital | Recruiting |
| Hasselt, Belgium, 3500 | |
| Contact: Contact Person Not Available | |
| Ziekenhuis Netwerk Antwerpen Middelheim | Recruiting |
| Antwerpen, Belgium, B-2020 | |
| Contact: Contact Person 32-3-280-2339 | |
| Ziekenhuis Netwerk Antwerpen Stuivenberg | Recruiting |
| Antwerpen, Belgium, B-2060 | |
| Contact: Contact Person Not Available | |
| Principal Investigator: | Dirk Schrijvers, MD, PhD | Ziekenhuis Netwerk Antwerpen Middelheim |
More Information
| Study ID Numbers: | CDR0000658351, ZNA-2008-FOD-GER001, EU-20985 |
| Study First Received: | October 30, 2009 |
| Last Updated: | October 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT01005693 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia |
meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia stage II adult T-cell leukemia/lymphoma stage II chronic lymphocytic leukemia |
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Precancerous Conditions Blood Protein Disorders Paraproteinemias Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Syndrome Lymphoma, Large-Cell, Immunoblastic Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Multiple Myeloma Lymphatic Diseases Neoplasms Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Myelodysplastic-Myeloproliferative Diseases Neoplasms, Plasma Cell |