Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Daily Fatigue |
Daily subjective fatigue will be measured by the MD Anderson Brief Fatigue Inventory (BFI). The BFI will be completed daily from day 1 of stimulation until day 1 of the next chemotherapy cycle. Participants will be given multiple copies of the BFI with the date marked on them to complete at home. Participants will return the completed BFI at a follow-up visit or by mail. The BFI measures the severity of fatigue and the degree to which it interferes with function. The BFI has 9 items. The first 3 items rate fatigue severity and are measured on a scale of 0, "no fatigue", to 10, fatigue "as bad as you can imagine." The remaining items rate interference of fatigue and are measured on a scale of 0, "does not interfere" to 10, "completely interferes." The recall period for the BFI is 24 hours. The BFI has been validated in patients with solid tumors including breast cancer and in patients receiving chemotherapy. The BFI takes only a few minutes to complete. |
Daily from Day 1 to End of study (approximately 3 weeks) |
|
Other |
Patient-Reported Side effects of tDCS |
Patient-Reported Side effects of tDCS will be assessed by a side effects questionnaire. This will include questions regarding physical sensations and mood experienced prior to and following each stimulation session (i.e. twice during all five sessions) to document the presence and severity of any tDCS-related side effects. Participants will be asked to rate the severity of these experiences and to report any other sensations they were not asked about directly. At the end of stimulation on the fifth day, each participant will also be asked whether he/she believes he/she was receiving active or sham tDCS as part of the side effects questionnaire and he/she will rate the degree of confidence with respect to these judgments. This questionnaire takes less than five minutes to complete. |
Before and after study intervention on Days 1, 2, 3, 4, 5 |
|
Other |
Cognitive Function other than working memory (TMT) |
The measurement tool for objective cognitive function for this objective will be the Trail Making Test (TMT). The TMT is composed of 2 parts (A and B). Part A is designed to evaluate visual motor scanning and processing speed. Part B is designed to evaluate processing speed and executive functioning. These tests require patients to connect circles in numerical (part A) or alternating numerical and alphabetical sequence (part B) as quickly as possible. Results are reported as the number of seconds required to complete each part, with higher scores reflecting higher degrees of impairment (range 0 - 300 seconds per trial). Normative data are available in the form of demographically adjusted T-scores. The task takes approximately 5 minutes to complete. Clinical trials have repeatedly shown the TMT to be sensitive to the impact of cancer and treatment-related neurotoxicities. Breast cancer survivors have been shown to produce z-scores of 0.56 ± 1.29 on part A and 0.15 ± 1.22 on part B. |
Before and after study intervention on Days 1-5 |
|
Other |
Cognitive Function other than working memory (CIFA) |
The measurement tools for objective cognitive function for this objective will be the Calibrated Ideational Fluency Assessment (CIFA). The CIFA verbal fluency trials are designed to evaluate verbal fluency and executive functioning. The task requires patients to name as many words as possible beginning with two different letters (letter fluency) and that belong to two different categories (category fluency) over four separate one-minute trials. The task takes approximately five minutes to complete. Scoring is based on the number of correct words produced over the course of the four trials, with greater values reflecting better performance. Normative data are available in the form of demographically adjusted T-scores. |
Before and after study intervention on Days 1-5 |
|
Other |
Chemotherapy administration |
Chemotherapy will be considered to be given on time if there is no more than 3 days delay (i.e. administered within 24 days of prior cycle of docetaxel-based chemotherapy). Timeliness of administration of chemotherapy after tDCS will be evaluated by chart review to determine if the next cycle of docetaxel-based chemotherapy is administered within 24 days of the chemotherapy administered during study participation and prior to tDCS (i.e. no more than 3 day delay in a 21 day cycle). This endpoint will only be evaluated in participants for whom an additional cycle of docetaxel-based chemotherapy is planned. |
End of study (approximately 3 weeks) |
|
Other |
Medical Record Review |
Available medical records will be reviewed in the electronic medical record to obtain information relative to factors which may impact the feasibility of tDCS and the effect of tDCS on fatigue, cognitive function and quality of life. Information obtained from charts may include but will not be limited to: breast cancer stage, baseline hemoglobin, # of prior cycles of docetaxel-based chemotherapy, concurrent cancer therapy, prior breast cancer surgery, prior breast cancer radiation, prior breast cancer systemic therapy, hormone receptor status, HER2 status, concurrent medications at study enrollment, substance use history, mental health history, marital status, history of thyroid disease, history of cerebrovascular disease, family history of neurologic disease, history of cardiopulmonary disease, steroid dose prior to docetaxel administration, supportive care medications and any other comorbid medical conditions. |
Baseline and End of study (approximately 3 weeks) |
|
Primary |
Feasibility of tDCS |
Evaluation of the feasibility of 5 consecutive days of tDCS in breast cancer patients receiving docetaxel-based chemotherapy. Feasibility will be evaluated by assessing the proportion of study participants who complete at least 4 of 5 days of the planned tDCS intervention (active or sham) during docetaxel-based chemotherapy. If >80% of participants complete 4 of the 5 planned stimulation sessions, tDCS will be defined as feasible. |
Day 5 |
|
Secondary |
Fatigue |
Participants will complete self-report measures of fatigue. The Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) will serve as the primary measurement tool for the assessment of subjective fatigue. This questionnaire assesses participants' subjective ratings across five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. Responses are provided on 5-point Likert-like scales addressing the extent to which each symptom was experienced during the preceding 7 days ranging from 0 (not at all) to 4 (extremely). The subscale scores are obtained by summing scores within each subscale. The MFSI-SF total score is obtained by subtracting the vigor subscale score from the sum of the four fatigue subscales. Scores range from -36 to 144. The MFSI-SF is well validated in breast cancer patients. Breast cancer patients with fatigue produce an average score of 14.7 ± 15.2. The MFSI-SF takes approximately 5 minutes to complete. |
Day 1, Day 5, and at End of study (approximately 3 weeks) |
|
Secondary |
Subjective Cognitive Function |
Participants will self-report measures of cognitive function at the beginning and end of the five-day intervention. The endpoint for subjective cognition will be scores on the FACT-Cog, a 37-item self-report measure. Responses are provided on 5-point Likert-like scales addressing the frequency with which each type of cognitive difficulty occurred from 0 (never) to 4 (several times a day) over the prior seven days. Two additional subscales address "noticeability" or comments from others regarding cognition and "effect of perceived cognitive impairment on quality of life." These are rated on 5-point Likert-like scales ranging from 0 (not at all) to 4 (very much). The total FACT-Cog score is obtained by summing the individual subscale scores and ranges from 0 to 148. Breast cancer patients produce a mean FACT-Cog total score of 119.0 ± 23.3.The FACT-Cog takes approximately 5 minutes to complete. |
Day 1, Day 5, and at end of study (approximately 3 weeks) |
|
Secondary |
Objective Cognitive Function |
Objective cognitive function from baseline (prior to tDCS) to completion of tDCS will be assessed. The measurement tool for objective cognitive function for this objective will be the Paced Auditory Serial Addition Test (PASAT) of working memory. The PASAT is working memory task that has been well-validated medical populations including breast cancer. Test administration involves the aural presentation of single digits via computer in order to ensure a standardized rate of stimulus presentation. Stimuli are presented every three seconds (trial 1) or every two seconds (trial 2). Participants add each new digit to the one immediately prior as the test continues to present stimuli. The test score reflects the total number of correct sums given (out of 60 possible) in each trial. Two equivalent, alternative PASAT forms will be used to minimize practice effects. The test takes approximately 10 minutes to complete. |
Day 1 and Day 5 |
|
Secondary |
Quality of Life |
The measurement tool for QOL will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The impact of tDCS on QOL will be assessed by the EORTC QLQ-C30. This 30-item questionnaire includes five functional scales (physical, role, emotional, social and cognitive), three symptom scales (fatigue, nausea/vomiting and pain), a global health status scale and six single items (dyspnea, constipation, diarrhea, appetite, sleep and financial difficulty). The first 28 questions are answered using a Likert-like scale ranging from 1, "not at all", to 4, "very much". The last two questions are answered on a Likert-like scale ranging from 1, "poor" to 7, "excellent". The recall period is 7 days. The EORTC QLQ-C30 has been extensively used as a quality of life measure in breast cancer clinical trials and is well validated in the breast cancer population. The EORTC QLQ-C30 takes approximately 5 minutes to complete. |
Day 1, Day 5, End of study (approximately 3 weeks) |
|