Cancer, Opioid Use, Pain Management
Conditions
Keywords
Cancer, Pain management, Opioid use, Health app, Gastrointestinal cancer, Breast cancer, Lung cancer
Brief summary
The purpose of the study is to develop the STAMP app (Smartphone Technology to Alleviate Malignant Pain). This app will be used by patients with advanced cancer to track symptoms and receive tailored symptom management advice. This is a single arm pilot feasibility study of the application among patients with advanced cancer and chronic pain who are using opioids in the home setting. Patients will be asked to use the application for a four week period. Clinicians responsible for the patients' pain management will be asked to review alerts from the STAMP system and respond accordingly. The primary outcomes of the study relate to feasibility and acceptability.
Detailed description
A pilot study will be conducted at DFCI to demonstrate the utilization and efficacy of the STAMP app among patients with chronic cancer pain and their cancer care providers. This will be a single arm study with up to 20 patients. Patients with advanced solid tumors who are using opioids to manage chronic cancer pain will be recruited from outpatient clinics (palliative care), and they will be asked to use the app for 4 weeks. Once a patient is enrolled in the study, a research assistant (RA) will set up the app, putting in the patient's prescribed opioids and laxatives. Patient will have access to educational materials about pain management and patient educational videos about pain management and opioids through the app. Patient will be prompted to take daily surveys for symptom reporting and medication updates. At the end of each survey patients receive, a summary of their symptom severity, with links to tailored educational content about pain management, and recommendations about how to safely titrate over-the-counter laxatives to manage opioid-induced constipation. This laxative advice operates within the parameters of normative and approved over-the-counter laxative use, and has been extensively reviewed, vetted, and approved by multidisciplinary groups of clinicians. If patients report any severe symptoms, they are instructed to contact their care team immediately, with a telephone number included on the application screen. If patients' pain is poorly controlled but not severe enough to be prompted to immediately contact their care team (for example if their average pain is above a 4 and not acceptable), they are reminded to contact their care teams if their symptoms worsen or they are concerned about it. Finally, if they report any concerning abdominal symptoms (e.g. no bowel movement in 4 or more days, haven't passed gas from bottom or ostomy, new or severe abdominal pain, vomiting two or more times in the past 24 hours), patients are not given any laxative titration instructions and are instead advised to contact their care team for more advice. The research team will monitor the portal where patient survey responses are presented. If a severe symptom is reported, the research team will contact the relevant nursing staff for clinical follow-up (as per the above paragraph, patients are always advised to contact their care teams for safety concerns, and there is no expectation for immediate nurse outreach). Nurses and physicians involved in the care of participating patients will also have access to patient-responses on the clinician portal. Participants will complete a brief survey at baseline and again at end of study (4 weeks). They will also be offered an optional qualitative debriefing at end of study.
Interventions
Patients with advances cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
Patient Inclusion Criteria: * Patient is cared for within participating clinic (PC) * Age ≥21 * Diagnosed with locally advanced, metastatic solid tumor, or multiple myeloma being managed with palliative intent * Chronic pain related to cancer or cancer treatment, persisting or at least two weeks * Average pain rating of ≥4/10 currently, or at least one day within the past week * Active prescription for short and/or long acting opioids * Takes at least 1 opioid medication on most days * Own a compatible smartphone: * iPhone, have updated or willing to update it to the past 3 iOS version releases * Android flagship devices with more than 5% market share, last 2 android version releases Clinician Inclusion Criteria: * Physicians and mid-level providers practicing in participating clinics and caring for a patient on the study * Nurse Navigators working within participating clinics
Exclusion criteria
Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Patient Log Ins | 4 Weeks | We will calculate the frequency that patients log in to the application using simple descriptive statistics. |
| Frequency of Symptom Survey Completion | 4 weeks | We will calculate the number of times patients completed a symptom survey on app during their 28 days on study. Patients could complete up to one symptom survey per day on study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-scale Acceptability | 4 Weeks | Patients will rate overall acceptability of the application using a modified acceptability e-scale. This 6-item measure asks patients to rate the app on ease of use, understandability, enjoyment, helpfulness, time spent, and overall satisfaction, on a 1 to 5 Likert scale. Items are summed to for a total score, ranging from 6 to 30 with 30 being the highest acceptability score. |
| Usability | 4 Weeks | Patients will complete a validated 10-item system usability scale (SUS) with total scores ranging from 0-100, where a score of 100 being the best possible usability score. |
Countries
United States
Participant flow
Pre-assignment details
20 participants where consented and enrolled on this single-arm intervention study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants Patients with advanced cancer using opioids for chronic pain will be enrolled and asked to use the STAMP cancer pain management app for 4 weeks. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Intervention Participants |
|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 12.3 |
| Education College degree (BA, BS, other) | 5 Participants |
| Education Higher level degree (MA, MS, MD, PhD, other) | 5 Participants |
| Education High school diploma | 3 Participants |
| Education Missing | 1 Participants |
| Education Some college (AA, other) | 6 Participants |
| Education Some high school | 0 Participants |
| Ethnicity Hispanic/LatinX | 0 Participants |
| Ethnicity Non-Hispanic/LatinX | 20 Participants |
| Marital Status Divorced | 1 Participants |
| Marital Status Married | 17 Participants |
| Marital Status Separated | 1 Participants |
| Marital Status Single | 1 Participants |
| Marital Status Widowed | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants |
| Race/Ethnicity, Customized I don't know | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 16 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Frequency of Patient Log Ins
We will calculate the frequency that patients log in to the application using simple descriptive statistics.
Time frame: 4 Weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Participants | Frequency of Patient Log Ins | 14 log ins to the application per patient |
Frequency of Symptom Survey Completion
We will calculate the number of times patients completed a symptom survey on app during their 28 days on study. Patients could complete up to one symptom survey per day on study.
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Participants | Frequency of Symptom Survey Completion | 8 completed symptom survey(s) per patient |
E-scale Acceptability
Patients will rate overall acceptability of the application using a modified acceptability e-scale. This 6-item measure asks patients to rate the app on ease of use, understandability, enjoyment, helpfulness, time spent, and overall satisfaction, on a 1 to 5 Likert scale. Items are summed to for a total score, ranging from 6 to 30 with 30 being the highest acceptability score.
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Participants | E-scale Acceptability | 24 score on the acceptability scale | Standard Deviation 4.37 |
Usability
Patients will complete a validated 10-item system usability scale (SUS) with total scores ranging from 0-100, where a score of 100 being the best possible usability score.
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Participants | Usability | 78.3 score on the SUS scale | Standard Deviation 16.2 |