Cancer Pain, Cognitive Behavior Therapy, Opioid Use
Conditions
Keywords
STAMP (Smartphone Technology to Alleviate Malignant Pain), CBT (Cognitive Behavioral Therapy), mHealth (Mobile Health technology)
Brief summary
The purpose of this study is to develop and pilot test a novel medical intervention (STAMP+CBT app) that will help patients track their pain, mood, opioid use and side effects while delivering tailored education and self-management advice for patients with advanced cancer.
Detailed description
The primary purpose of this project is to determine the feasibility and acceptability of a novel mobile health application (STAMP+CBT app). The STAMP+CBT app (Smartphone Technology to Alleviate Malignant Pain + Cognitive Behavioral Therapy) seeks to provide education about pain medications alongside cognitive behavioral therapy techniques for pain to patients with advanced cancer. The application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. In this study, patients with advanced cancer at OU will participate in a single-arm, 6-week study of STAMP+CBT (4-week intervention period and a 2-week post-intervention period).
Interventions
BEHAVIORALCognitive Behavioral Therapy for pain
Patient participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Sponsors
National Cancer Institute (NCI)
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The STAMP+CBT application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. The primary objective is to determine the feasibility and acceptability during the 6-week study of the STAMP+CBT app (4-week intervention period and a 2-week post intervention period). Specifically, in this study 35 patients are enrolled and will be evaluated for their adherence to daily and weekly comprehensive symptom based self-assessments within the STAMP+CBT app.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort Inclusion Criteria: * Age ≥ 18 years * Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive care * Chronic pain related to cancer or treatment (\> pain score of 4) * Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain) * Completed baseline survey Cohort
Exclusion criteria
* Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission * Cognitive impairment that would interfere with study participation, as judged by treating clinician * Inability to speak English (the intervention has not yet been translated to Spanish) * Enrolled in hospice * Currently hospitalized * Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS) * Pain primarily related to a recent surgery (within the last 2 weeks) We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App | 4-weeks | Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). Based on that patient's overall adherence rate/app retention rates will be calculated and intervention will be considered feasible if more than 70% of subjects complete any activity on the app at least 50% of days on study. |
| Proportion of Patients Who Rate the Acceptability Items 4 or Higher on the App. | 6-weeks | Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). In response to the survey's patient will be assigned tailored psychological intervention for advanced cancer pain. During the trial, these interventions will be considered acceptable only if 80% or more of the acceptability items are rated 4 or higher/5; Lower rating will lead to app refinements. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 1 site from May 2023 to February 2024. The first patient was enrolled on May 4, 2023 and the last patient was enrolled on February 8, 2024.
Pre-assignment details
Of 52 enrolled participants, 31 met inclusion criteria and assigned to the single arm study. Among 31 patients enrolled into the app, 16 completed all surveys.
Participants by arm
| Arm | Count |
|---|---|
| STAMP+CBT App This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms.
Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms.
Cognitive Behavioral Therapy for pain: Patient participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings). | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete all the surveys required for study. | 15 |
Baseline characteristics
| Characteristic | STAMP+CBT App |
|---|---|
| Age, Continuous | 55.41 years STANDARD_DEVIATION 12.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Rural Dwelling | 10 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App
Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). Based on that patient's overall adherence rate/app retention rates will be calculated and intervention will be considered feasible if more than 70% of subjects complete any activity on the app at least 50% of days on study.
Time frame: 4-weeks
Population: Patients who enrolled in the study and used the app
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP+CBT App | Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App | 19 Participants |
Primary
Proportion of Patients Who Rate the Acceptability Items 4 or Higher on the App.
Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). In response to the survey's patient will be assigned tailored psychological intervention for advanced cancer pain. During the trial, these interventions will be considered acceptable only if 80% or more of the acceptability items are rated 4 or higher/5; Lower rating will lead to app refinements.
Time frame: 6-weeks
Population: Patients who enrolled in the study and used the app and completed the survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAMP+CBT App | Proportion of Patients Who Rate the Acceptability Items 4 or Higher on the App. | 15 Participants |