Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Palliative Care Research Center | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.
This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.
The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app.
Participants will be on this research study for up to 6 weeks.
It is expected that about 15 people will take part in this research study
This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAMP+CBT PILOT | Experimental | Patients in this Pilot Cohort will be in the research study for 6 weeks total including:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAMP+CBT application | Behavioral | Use the STAMP+CBT mobile app for 4 weeks (intervention period, 4 weeks for content introduction, extended 2 weeks for review of content if patient's request this |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Intervention Adherence Rate | >70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period) | 4 Weeks |
| Acceptability Rate | Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.[Tariman, 2011] Higher scores indicated greater acceptability. Acceptability was pre-defined as >80% across all acceptability items rated as >4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Enrolled Participants Who Consented and Completed the Study | Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures. | 7 Months |
| Study Retention |
Not provided
Inclusion Criteria:
- PILOT COHORT
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Desiree Azizoddin, PsyD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber at Merrimack Valley |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38252172 | Derived | Azizoddin DR, DeForge SM, Baltazar A, Edwards RR, Allsop M, Tulsky JA, Businelle MS, Schreiber KL, Enzinger AC. Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain. Support Care Cancer. 2024 Jan 22;32(2):123. doi: 10.1007/s00520-024-08307-7. |
Not provided
Not provided
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Not provided
Not provided
Patients were recruited from outpatient palliative care clinics
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Cohort | Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Cohort | Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Overall Intervention Adherence Rate | >70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period) | Participants who tested the app for 4 weeks (n=8) completed daily their daily EMA surveys. | Posted | Mean | Standard Deviation | EMA App Surveys | 4 Weeks | Total EMA App Surveys | Total EMA App Surveys |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Cohort | Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Desiree Azizoddin | Dana Farber Cancer Institute | (617) 632-3000 | desiree_azizoddin@dfci.harvard.edu |
Not provided
| 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 | May 13, 2022 | Mar 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2022 | Aug 2, 2023 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the study was to have 60% of patients who enroll to the app will complete app use (use the app for 28 days) at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment
| 6 Months |
| COMPREHENSIVE ENDPOINT | Overall acceptability will be determined based on composite evaluation of acceptability ratings using the modified items from the Acceptability E-Scale [Tariman 2011]. Participants completed a modified version of the Acceptability e-scale, rating the app on a 5-point Likert scale on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction. Higher scores indicated higher acceptability. Acceptability was pre-defined as >80% of all acceptability items being rated individually as >4 out of 5 (possible scores on this scale range between 1-5). Acceptability was evaluated by determining the mean score on each item individually, across all participants (range of scale of score 1-5). | 6 Weeks |
| Methuen |
| Massachusetts |
| 01844 |
| United States |
| Dana-Farber at Londonderry | Londonderry | New Hampshire | 03053 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Acceptability Rate | Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.[Tariman, 2011] Higher scores indicated greater acceptability. Acceptability was pre-defined as >80% across all acceptability items rated as >4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5). | Evaluate each acceptability items that were rated as 4 or higher out of 5 for all patients | Posted | Mean | Standard Deviation | scores on a scale | 4 weeks |
|
|
|
| Secondary | Number of Enrolled Participants Who Consented and Completed the Study | Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures. | 10 patients were recruited in 7 months and 8 remained in the study and completed all study activities and measures. | Posted | Number | participants | 7 Months |
|
|
|
| Secondary | Study Retention | The goal of the study was to have 60% of patients who enroll to the app will complete app use (use the app for 28 days) at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment | Percent of patients who consented and also completed 4 weeks of app use and surveys at 4 and 6 weeks after enrollment | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| Secondary | COMPREHENSIVE ENDPOINT | Overall acceptability will be determined based on composite evaluation of acceptability ratings using the modified items from the Acceptability E-Scale [Tariman 2011]. Participants completed a modified version of the Acceptability e-scale, rating the app on a 5-point Likert scale on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction. Higher scores indicated higher acceptability. Acceptability was pre-defined as >80% of all acceptability items being rated individually as >4 out of 5 (possible scores on this scale range between 1-5). Acceptability was evaluated by determining the mean score on each item individually, across all participants (range of scale of score 1-5). | Patients rated the app's perceived acceptability on understandability, enjoyability, ease of use, time required to use it, and overall satisfaction on a 5-point Likert scale. | Posted | Mean | Standard Deviation | scores on a scale | 6 Weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Time acceptability |
|
| overall Satisfaction |
|