Trial Summary
What is the purpose of this trial?
Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain. The name of the study smartphone application involved in this study is: -STAMP+CBT
Research Team
DA
Desiree Azizoddine, PsyD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults over 22 with chronic pain from advanced cancer, who use a smartphone and take opioid medication for cancer pain. It's not for those who don't speak English, have cognitive issues, are hospitalized or in hospice care, currently in CBT treatment, or whose pain is from recent surgery.Inclusion Criteria
I am 22 years old or older.
I experience chronic pain from cancer or its treatment, with a pain level above 4.
I am currently being treated for an advanced cancer or receiving care to ease cancer symptoms.
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Exclusion Criteria
I can communicate effectively in English.
Conditions that hinder smartphone use
I have completed my cancer treatment and am not currently receiving treatment for advanced cancer.
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Treatment Details
Interventions
- STAMP + CBT (Behavioral Intervention)
Trial OverviewThe STAMP+CBT mobile app is being tested to see if it can help manage cancer-related chronic pain by combining psychological support (CBT) with guidance on using pain medications effectively through a digital platform.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort D: Digital Cancer Pain Education Packet + Usual CareExperimental Treatment1 Intervention
Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete:
* Baseline in-person or remote visit with introduction to the digital cancer pain education packet and pain tracker form.
* Completion of pain tracker
* Day 7 check in with study team
* Day 14 survey
* Day 28 surveys
* Optional in-person or remote semi-structured, exit interview to review the educational packet
* Day 42 (Week 6) follow-up survey
Group II: Cohort C: STAMP + CBT AppExperimental Treatment1 Intervention
Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete:
* Baseline in-person or remote visit with an introduction to the STAMP+CBT application.
* Surveys via the application 6 days per week.
* Day 7 check in with study team
* Day 14 survey
* Day 28 follow-up surveys
* Optional in-person or remote semi-structured, exit interview
* Day 42 (Week 6) follow-up survey
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Trials
1128
Patients Recruited
382,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+