An interventional study of Medication Event Monitoring System (MEMS^TM) and Questionnaires in Neurofibromatosis 1 and Neurofibroma, Plexiform, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 3 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Supportive care
Background:
Neurofibromatosis type 1 (NF1) is a genetic disorder. It has a broad variety of effects on the body. Up to half of people with NF1 get plexiform neurofibromas (PNs). These are benign tumors. But they can have serious effects like pain and disfigurement. To treat PNs, a person may have to take medicine every day for a long period of time. Researchers think that it will be important for people to take the medicine regularly for it to work. They want to study how well people with NF1 follow their treatment plan for PNs.
Objective:
To study how often people with neurofibromatosis type 1 take medicine that has been prescribed to them for treating plexiform neurofibromas.
Eligibility:
People ages 3-59 already enrolled in an NF1 clinical trial
Design:
Participants will need access to the internet to do the study activities.
Parents or caregivers will do some study activities for child participants.
Participants will complete 5 questionnaires. They will take about 20 minutes total. The topics will be:
Demographic data
Recent life events
How much pain interferes with daily life
Ability to focus and pay attention to tasks
Emotional distress or depression
Participants will mark down every time they take a dose of the medicine in their clinical trial. They will use a form the researchers give them. The pill bottles they get in their trial will have a chip in the cap that will record when it is opened. Participants will keep a daily diary of their medicine. Their pills will be counted at clinical trial visits.
Participants may have more short questionnaires. They may have interviews by phone or video.
Background:
Objective:
Eligibility:
Design:
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's enrollment of 12 is below the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Patient
Inclusion Criteria for Parents or Caregivers
EXCLUSION CRITERIA:
Exclusion Criteria for Patient
Exclusion Criteria for Parent or Caregiver
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Questionnaires and use of the medication event monitoring system (MEMS\^TM)
Behavioral: Medication Event Monitoring System (MEMS^TM) · Other: Questionnaires
Questionnaires and use of the medication event monitoring system (MEMS\^TM)
Behavioral: Medication Event Monitoring System (MEMS^TM) · Other: Questionnaires
A computerized method of tracking the dates and times of a pill bottle being opened.
Adult and pediatric participants completed a series of questionnaires to assess medication adherence, demographics, life events, and barriers to adherence.
Proportion of Enrolled Participants for Which we Are Able to Collect Data From the Medication Event Monitoring Systems (MEMS^TM) System for Two or More Cycles of Treatment (Target = 75%)
The proportion of enrolled participants are reported for individuals who had two full cycles of data recorded by the medication event monitoring systems (MEMS\^TM) system. To monitor medication adherence the medication event monitoring system (MEMSTM) used to track the dates and times a pill bottle was opened. At least 2 cycles of medication adherence are considered a success.
Time frame: Two cycles, approximately 56 days
Median Number of Cycles Monitored for Participants From the Medication Event Monitoring System (MEMS^TM)
To monitor medication adherence the medication event monitoring system (MEMSTM) was used to track the dates and times a pill bottle was opened. We calculated the median number of cycles monitored for all patients.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Average Percent Medication Adherence Over Time Based on the Medication Event Monitoring Systems (MEMS^TM) Pill Cap Data
To monitor medication adherence the medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. The mean of these numbers was computed across groups of cycles 1-4, 5-8, 9-12 and 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Higher number is better adherence.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
ANOVA (Analysis of Variance) Comparing Average Adherence Measured by Medication Event Monitoring Systems (MEMS^TM), Medication Diary, and Pill Count
A repeated-measures ANOVA was used to compare three adherence assessment methods over time. The medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. Pill count was used to assess how many pills were returned at each restaging visit compared to the number that should be returned if all medication was taken as prescribed. The daily diary was completed by participants, documenting date and timing of doses. The mean of these numbers was computed across groups of cycles (1 cycle = 28 days) 1-4, 5-8, 9-12 and 13-18 for the MEMS\^TM, Pill Count, and Daily Diary.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), an range of approximately 112 days to 504 days
Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Age
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and age, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4, cycles 5-8, cycles 9-12, and cycles 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Spearman Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap for Years of Education
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap for years of education, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Number of years of education was collected through participant self-report and was a continuous variable.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-scores
Outcome measures correlations between 2 variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap \& PROMIS Pain Interference T- Scores (Same for all PROMIS measures) Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-13hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle \& dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Pain Interference raw scores transformed to T-scores for analysis (mean:50,standard deviation: 10, higher scores is more pain interference, T of 55 is cutoff-mild pain interference).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Depression T-scores
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Depression Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Depression raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more depression symptoms, T of 55 is the cut off for mild depressive symptoms).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Quality of Life (QOL) Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Interference T-scores
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Cognitive Interference Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Cognitive Interference raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more cognitive interference, T of 60 represents mild interference).
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Barriers to Adherence Questionnaire
Participants completed a barriers questionnaire to assess barriers most frequently endorsed on the questionnaire. The questionnaire focused on any medication adherence issues during the trial (e.g., missed doses). Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that caused them to miss a dose of medication. Participants were also able to provide additional reasons for missing medication that were not on the form.
Time frame: Baseline and follow-up (between cycles 8 and 12; or after cycle 18/when taken off of study (range of 224-504 days)
Spearman's Correlation of the Relationship Between Medication Event Monitoring Systems (MEMS^TM) Cap and Barriers to Adherence Questionnaire
The outcome measures Spearman correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. Barriers to adherence was calculated by summing the number of barriers for each participant at follow-up. Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that apply to them.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Medication Event Monitoring Systems (MEMS^TM) Cap and Stressful Life Events: Number of Stressful Life Events Endorsed in the Life Events Checklist
To assess the relationship between the adherence method MEMS\^TM cap and stressful life events (i.e., the number of stressful life events endorsed in the Life Events Checklist), Spearman correlation was used. Participants complete a 22-item questionnaire to report stressful events that impact medication adherence. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Medication Event Monitoring Systems (MEMS^TM) Cap and Rating of Overall Stress
To assess the relationship between the adherence method MEMS\^TM cap and rating of overall stress, Spearman correlation was used. Participants complete a 1-item question asking them to rate their stress from 0 - 10, with higher numbers being more stressed. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
Time frame: Cycles 1-4, 5-8, 9-12 and 13-18 (1 cycle = 28 days), a range of approximately 112 days to 504 days
Number of Participants With Serious and/or Non-serious Adverse Events
Here is the number of participants with serious and/or non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Baseline to cycle 18 (end of study), approximately 504 days (1.38 years)
| Milestone | Adult Participants (18+ Years) | Pediatric Participants (3-17 Years) |
|---|---|---|
| Started | 12 | 0 |
| Completed | 12 | 0 |
| Not completed | 0 | 0 |
The proportion of enrolled participants are reported for individuals who had two full cycles of data recorded by the medication event monitoring systems (MEMS\^TM) system. To monitor medication adherence the medication event monitoring system (MEMSTM) used to track the dates and times a pill bottle was opened. At least 2 cycles of medication adherence are considered a success.
| Proportion of participants | Adult Participants (18+ Years) |
|---|---|
| Proportion of Enrolled Participants for Which we Are Able to Collect Data From the Medication Event Monitoring Systems (MEMS^TM) System for Two or More Cycles of Treatment (Target = 75%) | 0.9167 |
To monitor medication adherence the medication event monitoring system (MEMSTM) was used to track the dates and times a pill bottle was opened. We calculated the median number of cycles monitored for all patients.
| Cycles | Adult Participants (18+ Years) |
|---|---|
| Median Number of Cycles Monitored for Participants From the Medication Event Monitoring System (MEMS^TM) | 16 (0 to 18) |
To monitor medication adherence the medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. The mean of these numbers was computed across groups of cycles 1-4, 5-8, 9-12 and 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Higher number is better adherence.
| percent | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | 83.39 ± 16.71 |
| Cycles 5-8 | 87.01 ± 14.62 |
| Cycles 9-12 | 84.77 ± 15.44 |
| Cycles 13-18 | 79.68 ± 20.85 |
A repeated-measures ANOVA was used to compare three adherence assessment methods over time. The medication event monitoring system (MEMS\^TM) was used to track the dates and times a pill bottle was opened. The number of times the bottle was opened was divided by the total number of times the bottle should be opened according to provider instructions. Pill count was used to assess how many pills were returned at each restaging visit compared to the number that should be returned if all medication was taken as prescribed. The daily diary was completed by participants, documenting date and timing of doses. The mean of these numbers was computed across groups of cycles (1 cycle = 28 days) 1-4, 5-8, 9-12 and 13-18 for the MEMS\^TM, Pill Count, and Daily Diary.
| ANOVA F-Value | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | 11.944 |
| Cycles 5-8 | 7.770 |
| Cycles 9-12 | 6.670 |
| Cycles 13-18 | 6.333 |
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and age, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4, cycles 5-8, cycles 9-12, and cycles 13-18. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average.
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -0.210 |
| Cycles 5-8 | 0.134 |
| Cycles 9-12 | .095 |
| Cycles 13-18 | .333 |
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap for years of education, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. Number of years of education was collected through participant self-report and was a continuous variable.
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -0.333 |
| Cycles 5-8 | -0.309 |
| Cycles 9-12 | -0.259 |
| Cycles 13-18 | -0.222 |
Outcome measures correlations between 2 variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap \& PROMIS Pain Interference T- Scores (Same for all PROMIS measures) Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-13hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle \& dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Pain Interference raw scores transformed to T-scores for analysis (mean:50,standard deviation: 10, higher scores is more pain interference, T of 55 is cutoff-mild pain interference).
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -.215 |
| Cycles 5-8 | 0.049 |
| Cycles 9-12 | -0.048 |
| Cycles 13-18 | -0.167 |
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Depression Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Depression raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more depression symptoms, T of 55 is the cut off for mild depressive symptoms).
| Correlation coefficients | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -.607 |
| Cycles 5-8 | -0.658 |
| Cycles 9-12 | -0.708 |
| Cycles 13-18 | -0.878 |
The outcome measures correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. To assess the relationship between the adherence method MEMS\^TM cap and PROMIS Cognitive Interference Scores, Spearman correlation was used. For this analysis, MEMS\^TM was defined as the average mean adherence for cycles 1-4. A dose was considered adherent if it was taken within an 11-to-13-hour interval from the prior correct dose. The mean was computed by summing medication adherence across the cycle and dividing it by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data to compute the average. PROMIS Cognitive Interference raw scores were transformed to T-scores for analysis (mean: 50, standard deviation: 10, higher scores is more cognitive interference, T of 60 represents mild interference).
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | 0.293 |
| Cycles 5-8 | 0.278 |
| Cycles 9-12 | 0.229 |
| Cycles 13-18 | 0.530 |
Participants completed a barriers questionnaire to assess barriers most frequently endorsed on the questionnaire. The questionnaire focused on any medication adherence issues during the trial (e.g., missed doses). Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that caused them to miss a dose of medication. Participants were also able to provide additional reasons for missing medication that were not on the form.
| Participants | Adult Participants (18+ Years) |
|---|---|
| Most commonly reported barrier at baseline: Away from home | 0 |
| Most commonly reported barrier at baseline: Busy with other things | 0 |
| Most commonly reported barrier at baseline: Forgot | 0 |
| Most commonly reported barrier at baseline: Had too many pills to take | 0 |
| Most commonly reported barrier at baseline: Wanted to avoid having side effects | 0 |
| Most commonly reported barrier at baseline: Did not want others to see taking medication | 0 |
| Most commonly reported barrier at baseline: Change in daily routine | 0 |
| Most commonly reported barrier at baseline: Too tired or slept through dose time | 0 |
| Most commonly reported barrier at baseline: Felt sick or ill | 0 |
| Most commonly reported barrier at baseline: Felt sad or stressed out | 0 |
| Most commonly reported barrier at baseline: Had problem taking medicine with clear liquid | 0 |
| Most commonly reported barrier at baseline: Had difficulty swallowing pills | 0 |
| Most commonly reported barrier at baseline: Ran out of pills | 0 |
| Most commonly reported barrier at baseline: Didn't like taste of medicine | 0 |
| Didn't think medicine was working | 0 |
| Most commonly reported barrier at baseline: Didn't feel like it/Needed a break | 0 |
| Most commonly reported barrier at baseline: Other reason | 0 |
| Most commonly reported barrier at follow-up: Forgetting | 6 |
The outcome measures Spearman correlations between two variables and the resulting correlation coefficient describes the strength of the relationship between the variables. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data. Barriers to adherence was calculated by summing the number of barriers for each participant at follow-up. Participants were given 16 possible reasons that they may have missed a dose and were asked to check all items that apply to them.
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -0.576 |
| Cycles 5-8 | -0.680 |
| Cycles 9-12 | -0.835 |
| Cycles 13-18 | -0.933 |
To assess the relationship between the adherence method MEMS\^TM cap and stressful life events (i.e., the number of stressful life events endorsed in the Life Events Checklist), Spearman correlation was used. Participants complete a 22-item questionnaire to report stressful events that impact medication adherence. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -0.035 |
| Cycles 5-8 | 0.227 |
| Cycles 9-12 | 0.179 |
| Cycles 13-18 | 0.041 |
To assess the relationship between the adherence method MEMS\^TM cap and rating of overall stress, Spearman correlation was used. Participants complete a 1-item question asking them to rate their stress from 0 - 10, with higher numbers being more stressed. MEMS\^TM was defined as the average mean adherence, an adherent dose was taken 11-13 hours from the prior correct dose. The mean was computed by dividing medication adherence across the cycle by the number of days within the cycle. Then, the average mean was calculated by using Statistical Package for the Social Sciences (SPSS) MEAN function, which uses all non-missing data.
| Correlation coefficient | Adult Participants (18+ Years) |
|---|---|
| Cycles 1-4 | -0.638 |
| Cycles 5-8 | -0.361 |
| Cycles 9-12 | -0.407 |
| Cycles 13-18 | -0.180 |
Here is the number of participants with serious and/or non-serious adverse events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Adult Participants (18+ Years) |
|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events | 0 |
Collected over Baseline to cycle 18 (end of study), approximately 504 days (1.38 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Participants (18+ Years) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Adult Participants (18+ Years) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Age, Continuous(years) | Adult Participants (18+ Years) |
|---|---|
| Mean | 34.36 ± 8.91 |
| Sex: Female, Male(Participants) | Adult Participants (18+ Years) |
|---|---|
| Female | 5 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Adult Participants (18+ Years) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Adult Participants (18+ Years) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Adult Participants (18+ Years) |
|---|---|
| United States | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely.
Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute (NCI) →