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STAMP+CBT mHealth for Cancer Pain
NA trial testing STAMP+CBT application in Active Cancer in 10 participants. Completed in 27 June 2023.
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 10 |
| Start date | 1 July 2022 |
| Primary completion | 8 June 2023 |
| Estimated completion | 27 June 2023 |
| Sites | 3 locations across United States |
Dana-Farber Cancer Institute
18 and older, any sex, with Active Cancer or Active Cancer Treatment. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
\>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)
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 15.75 | ± 6.76 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 4.26 | ± 1.07 |
Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures.
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 8 |
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
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 8 |
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 be
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 4.29 | ± 0.45 |
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 5.0 | ± 0 |
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 4.14 | ± 0.64 |
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 4.14 | ± 0.99 |
| Group | Value | 95% CI |
|---|---|---|
| Pilot Cohort | 4.29 | ± 0.45 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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