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URCC 10055 - "Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up"
NOTES:
1) Each pt must be matched w/an appropriate control subject (family member or friend of same gender & w/i 5 yrs of same age as pt, or a control subject identified by the registering site). If the control subject is from the registering site, they must have no experience in administering cognitive testing or access to this study's testing materials or procedures. Control subjects will be assessed at same 3 timepoints as the pt (must be registered & assessed w/i 2 mos of each other).
2) Individuals administering the cognitive tests (CANTAB & paper/pencil) must be trained. Training available via teleconference & computers are provided for CANTAB testing (contact KCCOP).
3) Training in blood handling procedures is required (unless already trained for URCC 08106 - EXCAP study). See procedure manual & videos. Contact KCCOP for kits.
4) Subjects will be compensated: Asmts 1 & 2 ($15 each) & Asmt 3 ($30).
Treatment Plan (Supplied Drug: N/A)
ASSESSMENT 1 (w/i 7 days prior to 1st chemo) - ALL STUDY SUBJECTS
On-Study Data Form, Clinical Record, & Med Usage
Computerized & Validated CANTAB Tests (motor function, memory, attention, executive function)
WRAT-4 (paper/pencil neuropsychological test)
Paper/Pencil Neuropsychological Tests (memory, executive function, attention)
Blood Collection for Cytokine & Genetic Markers
Self-Reporting Measures (at clinic or home) -- cognitive, executive function, & symptom inventory; QOL (chemo pts only); anxiety; fatigue; sleep; physical activity
Follow-Up Phone Call by URCC Research Staff (w/i 1 wk of in-clinic asmt, but prior to beginning of therapy; 4 brief cognitive tests) - notify URCC of asmt date.
ASSESSMENT 2 (w/i 1 mo following completion of chemo) - ALL STUDY SUBJECTS
Med Usage Update & Cancer Treatment Dosage Form
Computerized & Validated CANTAB Tests (motor function, memory, attention, executive function)
Paper/Pencil Neuropsychological Tests (memory, executive function, attention)
Blood Collection for Cytokine & Genetic Markers
Self-Reporting Measures (at clinic or home) -- cognitive, executive function, & symptom inventory; QOL (chemo pts only); anxiety; fatigue; sleep; physical activity
Follow-Up Phone Call by URCC Research Staff (w/i 1 wk following Asmt 2) - notify URCC of asmt date.
ASSESSMENT 3 (6 mos following Asmt 2) - ALL STUDY SUBJECTS
Med Usage Update & Cancer Treatment Dosage Form
Computerized & Validated CANTAB Tests (motor function, memory, attention, executive function)
Paper/Pencil Neuropsychological Tests (memory, executive function, attention)
Self-Reporting Measures (at clinic or home) -- cognitive, executive function, & symptom inventory; QOL (chemo pts only); anxiety; fatigue; sleep; physical activity
Follow-Up Phone Call by URCC Research Staff (w/i 1 wk following Asmt 3) - notify URCC of asmt date.
Eligibility
SUBJECTS RECEIVING CHEMO
Invasive breast cancer (Stg I-IIIC) or interm- or high-grade lymphoma (defined by treating investigator).
Scheduled to begin chemo. Oral chemo is allowed. Prior or concurrent tx w/hormones or biological response modifiers is acceptable (no biological response modifiers only).
Chemo naive.
Life expectancy >10 mos.
Able to speak & read English.
Age >21.
No current or w/i 1 yr hospitalization for psychiatric illness.
No neurodegenerative disease. Prior TIA or stroke is allowed if >1 yr prior & no remaining symptoms.
No prim CNS disease.
No concurrent RT while receiving chemo.
No urrent or prior mets disease (subjects w/breast cancer).
Not pregnant.
Not colorblind.
Signed informed consent.
CONTROLS
Same gender as subject receiving chemo.
<5 yrs of age of subject receiving chemo.
Life expectancy >10 mos.
Able to speak & read English.
Age >21.
Willing to participate in study for entire period.
No current or w/i 1 yr hospitalization for psychiatric illness.
No neurodegenerative disease. Prior TIA or stroke is allowed if >1 yr prior & no remaining symptoms.
No prim CNS disease.
No cancer dx or prior chemo.
Not pregnant or planning to become pregnant.
Not colorblind.
Signed informed consent.