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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA263838-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAMP+CBT app | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for pain | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-weeks |
| 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. | 6-weeks |
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Cohort Inclusion Criteria:
Cohort Exclusion Criteria:
We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
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| Name | Affiliation | Role |
|---|---|---|
| Desiree Azizoddin, PsyD | Stephenson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73117 | United States |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: Patients 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who enrolled in the study and used the app | Posted | Count of Participants | Participants | 4-weeks |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: Patients 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Desiree Azizoddin, PsyD | Harvard Medical School | 4052718001 | 50516 | desiree_azizoddin@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2023 | Sep 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Rural Dwelling | Count of Participants | Participants |
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|
| 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. | Patients who enrolled in the study and used the app and completed the survey | Posted | Count of Participants | Participants | 6-weeks |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |