Clinical trial · Interventional
STAMP+CBT mHealth for Cancer Pain
Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain
NCT05403801CI-TRIAL-00084256completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Cancer | — | UNRESOLVED | — |
| Active Cancer Treatment | — | UNRESOLVED | — |
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Chronic Pain Due to Cancer | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STAMP+CBT application | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STAMP+CBT PILOT
- description
- Patients in this Pilot Cohort will be in the research study for 6 weeks total including: * a 4-week intervention period and 2-week post intervention period. * Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period).
- interventionNames
- Behavioral: STAMP+CBT application
Primary outcomes (2)
- measure
- Overall Intervention Adherence Rate
- timeFrame
- 4 Weeks
- description
- \>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)
- measure
- Acceptability Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAzizoddin 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. PMID 38252172