Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in patient-reported neuropathy |
Measured using the neuropathy subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTX-13) questionnaire, which assesses the presence, severity and impact of neuropathy symptoms in patients receiving neurotoxic chemotherapy. The scale ranges from 0-52, with lower scores indicating worse quality of life due to neuropathy. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Primary |
Change in patient-reported neuropathy |
Measured using the Patient-Reported Outcomes version of the Common Toxicity Criteria and Adverse Events version 1.0 (PRO-CTCAE™) reporting tool. Two items from the PRO-CTCAE™ ask if the patient experienced numbness or tingling in the hands or feet in the last 7 days using a 5-pt scale (0=none to 4=very severe) and how much the symptom interfered with their daily life using a 5-pt scale (0=not at all to 4=very much). |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Primary |
Change in perceived disability |
Measured using the disability component of the Late-Life Function and Disability Instrument (LLFDI) which assesses disability in terms of frequency and limitation in performing 16 life tasks. Scores range from 0 to 100, with higher scores indicating less disability. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Primary |
Change in daily functional mobility |
Measured using instrumented socks (APDM.com) with inertial sensors embedded into neoprene ankle wraps. Patients wear the instrumented socks during waking hours over 7-day periods that correspond to each in-clinic assessment. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Primary |
Change in daily physical activity |
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/d). Patients wear the devices over 7-day periods that correspond to each in-clinic assessment. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Falls |
Falls over the past 12 months will be assessed retrospectively at baseline and prospectively at weekly intervals using in-house surveys. These surveys ask subjects about the number of falls, the number of injurious falls, and medical care resulting from a fall during the observation period. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in quality of life |
Measured using the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire for Cancer (EORTC-QLQ-C30). Global quality of life and subdomains of quality of life are scored from 0-100, with higher scores indicating better quality of life. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in patient-reported symptoms |
Assessed weekly with the Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE™) reporting tool items. The PRO-CTCAE™ uses 5-pt scales to assess the severity (0=none to 4=very severe), frequency (0=never to 4=almost constantly), and interference (0=not at all to 4=very much) of symptoms in daily life within the previous 7 days. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in objective loss of perceived sensation |
Measured using a tuning fork test. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in objective loss of perceived sensation |
Measured using biothesiometry. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in upper extremity strength |
Measured by handgrip dynamometry. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in static balance |
Measured by a postural sway test that assesses how well a person maintains their balance during 30 seconds of quiet standing using Mobility Lab sensors and software (APDM.com). Increased sway indicates poor balance control and is associated with increased risk of falls. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in functional mobility |
Measured by the Timed Up and Go (TUG) test. The TUG test evaluates the time that it takes a person to rise from a chair, walk 3 meters, then turn around and return to the chair in a seated position. Slower TUG times are associated with an increased risk of falls and disability. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in objective functional strength |
Measured by a timed chair stand test (seconds required to rise from a chair 5 times). Chair stand time >12 seconds has been shown to predict a 2.4 increased risk of falls in older adults. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
|
Secondary |
Change in skeletal muscle index |
Clinically acquired abdominal and thoracic computed tomography images will be segmented into fat and lean tissue compartments according to their non-overlapping radiodensity ranges. Skeletal muscle index is calculated as skeletal muscle cross-sectional area divided by height in meters squared. |
Baseline up to 1 year after completion of chemotherapy (average of 16 months) |
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