N/A
N=10
STAMP+CBT mHealth for Cancer Pain
Active Cancer · Active Cancer Treatment · Advanced Cancer · Palliative Care · Chronic Pain Due to Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05403801 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Overall Intervention Adherence Rate — 15.75 EMA App Surveys
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STAMP+CBT application (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Intervention Adherence Rate |
15.75 | — |
| PRIMARY Acceptability Rate |
4.26 | — |
| SECONDARY Number of Enrolled Participants Who Consented and Completed the Study |
8 | — |
| SECONDARY Study Retention |
8 | — |
| SECONDARY COMPREHENSIVE ENDPOINT |
4.29; 5.0; 4.14; 4.14; 4.29 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- PILOT COHORT
- Age ≥ 18 years
- Patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care
- Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry)
- 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)
- Own a compatible smartphone (android) or is willing to use an android device provided by the study team
- Completes baseline survey
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
- History of opioid use disorders
- 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
Data sourced from ClinicalTrials.gov (NCT05403801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.