Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Prostate Carcinoma
Conditions
Brief summary
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
Interventions
OTHEREducational Intervention
Receive educational materials and resources
OTHERElectronic Health Record Review
Ancillary studies
PROCEDUREFollow-Up
Receive follow-up contact
OTHERInternet-Based Intervention
Use self-monitoring platform
OTHERInterview
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants are adult patients (aged 18 years or older) * Diagnosed with lung, colorectal, breast, or prostate cancer * Are currently receiving active cancer treatments * Are self-managing one or more prescribed cancer medications * Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns * Speaks and reads English or has a support person (family member or friend) who can assist
Exclusion criteria
* Can't access technology or do not use technology * Do not have access to the internet * Do not speak or read English * Not permitted to participate by their health care providers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported system usability | Up to 6 months | Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Perceived usefulness | Up to 6 months | Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
| Ease of use | Up to 6 months | Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
| Attitudes toward use | Up to 6 months | Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
| Intention to use and continuous use of the system over time | Up to 12 months | Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
| Self-reported patient engagement | Up to 6 months | Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes. |
| System usage over time | Up to 12 months | Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Patient activation levels | Up to 6 months | Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Medication self-management ability | Up to 6 months | Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Symptom distress | Up to 6 months | Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Health related quality of life | Up to 6 months | Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Number of emergency room visits | Up to 12 months | Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| Number of hospitalizations | Up to 12 months | Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
| User experiences with the system | Up to 6 months | Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-tracked, structured medication safety events or concerns | Up to 12 months | To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume. |
Countries
United States
Contacts
CONTACTYun Jiang
PRINCIPAL_INVESTIGATORYun Jiang
University of Michigan Rogel Cancer Center
PRINCIPAL_INVESTIGATORYang Gong
UTHealth Houston McWilliam School of Biomedical Informatics
Outcome results
None listed