Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in inhibitory control |
Change in interference score on Stroop task, with negative values indicating lower inhibitory control. The Stroop task interference score is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in cognitive flexibility |
Change in reaction time on Task-switch task, with higher values indicating lower cognitive flexibility. The Task-switch reaction time is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in executive function |
Change in completion time on Trails B task, with higher values indicating lower executive function. Trails B completion time is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in spatial working memory reaction time |
Change in reaction time on spatial working memory task, with faster reaction times indicating better spatial working memory. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in short term memory |
Change in accuracy on N-Back task, with higher accuracy indicating better short-term memory. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in processing speed |
Change in accuracy on Attentional Blink task, with higher accuracy indicating faster processing speed. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in verbal memory |
Change in number recalled on Hopkins Verbal Learning Task, with greater number of items recalled indicating better verbal memory. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in visuospatial function |
Change in accuracy on Benton Judgement of Line Orientation task, with higher accuracy indicating better visuospatial function. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Primary |
Change in white matter integrity |
Change in fractional anisotropy as measured by diffusion MRI. |
Baseline (M0), 6-month follow-up (M6) |
|
Primary |
Change in brain volume |
Change in mean cortical thickness of brain regions of interest as measured by an anatomical MRI brain scan. |
Baseline (M0), 6-month follow-up (M6) |
|
Primary |
Change in resting state functional connectivity |
Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence. |
Baseline (M0), 6-month follow-up (M6) |
|
Primary |
Change in self-reported cognitive function |
The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be sued to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in appendicular lean mass index |
Change in appendicular lean mass index (ALMI) as measured by dual-energy X-ray absorptiometry (DXA) with higher scores indicating more lean mass. Appendicular lean mass, as measured by DXA, will be divided by height to determine ALMI. ALMI score is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in physical function |
The Short Physical Performance Battery (SPPB) will be used to assess physical function. Higher scores on the SPPB are indicative of better physical function. The SPPB has a minimum score of 0 and a maximum score of 12. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in functional capacity |
The Six Minute Walk Test (6MWT) will be used to measure functional capacity. The 6MWT is scored as distance walked in the 6 minutes with greater distance indicating greater functional capacity. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in upper body strength |
Change in grip strength as measured by hand grip dynamometry with higher scores indicating greater upper body strength. Hand grip strength is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in lower body strength |
Change in quadriceps strength as measured by hand-held quadriceps dynamometry with higher scores indicating greater lower body strength. Quadriceps strength is a continuous variable with no minimum or maximum value. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in physical activity |
Change in daily minutes of moderate to vigorous physical activity (MVPA) will be measured via accelerometry with more minutes of daily MVPA indicating more physical activity. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
|
Secondary |
Change in cancer-related fatigue |
The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue. |
Baseline (M0), 6-month follow-up (M6), 12-month follow-up (M12) |
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