Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ, Hot Flashes
Conditions
Brief summary
This trial studies how well EMBr Wave technology works in reducing hot flashes in women with a history of breast cancer. Hot flashes are a common symptom experienced by menopausal women. The standard treatment for hot flashes is hormone replacement therapy, however hormone replacement therapy cannot be used in women with a history of, or active, breast cancer. EMBr Wave is a personal heating and cooling device worn on the wrist. EMBr Wave may help reduce hot flash severity in women with a history of breast cancer.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the feasibility of using EMBr Wave technology in women with a history of breast cancer who are experiencing bothersome hot flashes. SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of EMBr Wave in reducing hot flash severity and frequency in women with a history of breast cancer. II. To identify in what ways EMBr Wave has the greatest potential efficacy, such as reduction in vasomotor symptoms (VMS) severity, frequency, duration, sense of control, or self-esteem. III. To estimate effect sizes to inform power calculations for a future phase III trial. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients utilize the EMBr Wave device for 4 weeks, then crossover to arm B for 4 weeks. ARM B: Patients receive no treatment for 4 weeks, then crossover to arm A for 4 weeks.
Interventions
DEVICEEMBr Wave
Use EMBr Wave
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Embr Labs, Inc.
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with history of breast cancer, ductal breast carcinoma in situ (DCIS), or lobular breast carcinoma in situ (LCIS) (currently without evidence of malignant disease) * Bothersome hot flashes (defined by their occurrence of \>= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention) * Presence of hot flashes for \> 30 days prior to study entry * Ability to complete questionnaire(s) by themselves or with assistance * Willingness to wear EMBr Wave device during the study period * Willingness to use the EMBr Wave mobile application * Have a working smartphone that can download the EMBr Wave mobile application (iPhone 6 or more recent generation, Android 8.0 or more recent generation) * Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1 * Ability to provide informed written consent * Life expectancy \>= 6 months
Exclusion criteria
* Antineoplastic chemotherapy (anti-HER2 agents allowed) (current \[=\< 4 weeks prior\] or planned therapy) * Androgens (current \[=\< 4 weeks prior\] or planned therapy) * Systemic estrogens. Local vaginal estrogen preparations are allowed, but need to have been initiated for vulvo-vaginal atrophy at least 28 days prior, and must not be expected to stop or change the dose or frequency of the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy) * Progestogens (current \[=\< 4 weeks prior\] or planned therapy) * Tamoxifen, raloxifene and aromatase inhibitors are allowed, but patient must have been on a constant dose for at least 28 days and must not be expected to stop the medication during the study period (current \[=\< 4 weeks prior\] or planned therapy) * Selective serotonin reuptate inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitor (SNRIs), when being used for hot flash management or other indications such as depression, is allowed, assuming the dose will remain unchanged for the study duration (current \[=\< 4 weeks prior\] or planned therapy) * Gabapentin/pregabalin, when being used for hot flash management (use for other indications, such as pain, is allowed, assuming the dose will remain unchanged for the study duration) (current \[=\< 4 weeks prior\] or planned therapy) * Clonidine (current \[=\< 4 weeks prior\] or planned therapy) * Prior use of EMBr Wave * Nickel allergy * Pregnant or nursing women since the safety of device has not been established in this population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Usage | Up to 8 weeks | Feasibility will be evaluated primarily with respect to device usage. The proportion of patients who wear the device for at least 8 hours between 8:00 am and 8:00 pm for at least 22 days will be estimated using the entire sample and a 95% Jeffreys interval for binomial proportions will be computed. |
| Patient Satisfaction | At 8 weeks | Feasibility will be evaluated secondarily with respect to patient satisfaction. The mean patient satisfaction scores for each Likert-type question and proportion of patients reporting satisfaction scores at or above 7 will be estimated in the entire sample and compared between sequence groups at the 5% significance level (two-sided).Rated on a 10-point Likert scale with 10 being most satisfied or most effective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | At week 4 and at week 8 | Reported via patient reported outcomes, primarily Hot Flash-Related Daily Interference Scale (HFRDIS), a scale of 0-10 with 0 being no interference (best outcome) and 10 being completely interfere (worst outcome). Survey administered on paper or via RedCap survey distribution at week 4 and week 8. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A (EMBr Wave First) Patients utilize the EMBr Wave device for 4 weeks, then receive no treatment for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies | 25 |
| Arm B (EMBr Wave Second) Patients receive no treatment for 4 weeks, then utilize the EMBr Wave device for 4 weeks.
EMBr Wave: Use EMBr Wave
Questionnaire Administration: Ancillary studies | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Arm A (EMBr Wave First) | Arm B (EMBr Wave Second) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 25 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 23 Participants | 45 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Device Usage
Feasibility will be evaluated primarily with respect to device usage. The proportion of patients who wear the device for at least 8 hours between 8:00 am and 8:00 pm for at least 22 days will be estimated using the entire sample and a 95% Jeffreys interval for binomial proportions will be computed.
Time frame: Up to 8 weeks
Population: Data was not collected or analyzed
Primary
Patient Satisfaction
Feasibility will be evaluated secondarily with respect to patient satisfaction. The mean patient satisfaction scores for each Likert-type question and proportion of patients reporting satisfaction scores at or above 7 will be estimated in the entire sample and compared between sequence groups at the 5% significance level (two-sided).Rated on a 10-point Likert scale with 10 being most satisfied or most effective.
Time frame: At 8 weeks
Population: Patient satisfaction data was only obtained for the 29 out of 50 participants who gave responses for the exit survey (12 from Arm A and 17 from Arm B). Satisfaction scores pertain to satisfaction with EMBr wave device usage, so no data is reported for the No Treatment Group
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A (EMBr Wave First) | Patient Satisfaction | Intensity | 4.97 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Duration | 5.48 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Work | 4.76 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Social | 4.72 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Leisure | 4.86 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Sleep | 4.41 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Mood | 4.97 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Concentrate | 4.90 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Relation | 4.41 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Sexuality | 3.24 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Enjoy | 5.10 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Quality | 5.38 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Worth | 5.79 score on a scale |
| Arm A (EMBr Wave First) | Patient Satisfaction | Satisfy | 5.52 score on a scale |
Secondary
Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS)
Reported via patient reported outcomes, primarily Hot Flash-Related Daily Interference Scale (HFRDIS), a scale of 0-10 with 0 being no interference (best outcome) and 10 being completely interfere (worst outcome). Survey administered on paper or via RedCap survey distribution at week 4 and week 8.
Time frame: At week 4 and at week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Leisure Activities | 3.4362 units on a scale | Standard Error 0.3063 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Concentration | 3.7391 units on a scale | Standard Error 0.3464 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Social Activities | 3.0626 units on a scale | Standard Error 0.3356 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Relations with others | 2.5774 units on a scale | Standard Error 0.3331 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Sleep | 4.8231 units on a scale | Standard Error 0.3948 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Sexuality | 2.9739 units on a scale | Standard Error 0.4058 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Enjoyment of Life | 3.2259 units on a scale | Standard Error 0.3234 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Work | 3.6368 units on a scale | Standard Error 0.3386 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Quality of Life | 3.4489 units on a scale | Standard Error 0.3248 |
| Arm A (EMBr Wave First) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Mood | 3.7743 units on a scale | Standard Error 0.3367 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Quality of Life | 3.5543 units on a scale | Standard Error 0.3386 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Work | 3.6743 units on a scale | Standard Error 0.3261 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Social Activities | 3.1652 units on a scale | Standard Error 0.359 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Leisure Activities | 3.5256 units on a scale | Standard Error 0.3566 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Sleep | 5.4950 units on a scale | Standard Error 0.3403 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Mood | 4.0794 units on a scale | Standard Error 0.3254 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Concentration | 4.1341 units on a scale | Standard Error 0.3634 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Relations with others | 2.6717 units on a scale | Standard Error 0.352 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Enjoyment of Life | 3.3231 units on a scale | Standard Error 0.3651 |
| Arm B (EMBr Wave Second) | Effect of EMBr Wave Using Hot Flash-Related Daily Interference Scale (HFRDIS) | Sexuality | 3.1144 units on a scale | Standard Error 0.4228 |