Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

Opioid Use Clinical Trial

— STAMP+CBT  

Official title:

Leveraging mHealth to Deliver Integrated Pain-CBT, Opioid Monitoring, and Self-management Support for Advanced Cancer Patients Coping With Chronic Pain (STAMP+CBT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774197
• Other study ID #: STAMP+CBT
• Secondary ID: 1R21CA263838-01
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: University of Oklahoma
• Contact: Desiree Azizoddin, PsyD
• Phone: 405.271.8001
• Email: Desiree-Azizoddin[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and pilot test a novel medical intervention (STAMP+CBT app) that will help patients track their pain, mood, opioid use and side effects while delivering tailored education and self-management advice for patients with advanced cancer.

Description:

The primary purpose of this project is to determine the feasibility and acceptability of a novel mobile health application (STAMP+CBT app). The STAMP+CBT app (Smartphone Technology to Alleviate Malignant Pain + Cognitive Behavioral Therapy) seeks to provide education about pain medications alongside cognitive behavioral therapy techniques for pain to patients with advanced cancer. The application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. In this study, patients with advanced cancer at OU will participate in a single-arm, 6-week study of STAMP+CBT (4-week intervention period and a 2-week post-intervention period).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Cohort Inclusion Criteria:

• Age = 18 years

• Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive care

• 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)

• Completed baseline survey

Cohort 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)

• 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 (within the last 2 weeks)

We will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Related Conditions & MeSH terms

• Cancer Pain
• Cognitive Behavior Therapy
• Opioid Use

Intervention

Behavioral:
• Cognitive Behavioral Therapy for pain
Patient participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who complete more than 2/3rd of the study modules at the end of 4 weeks of intervention to determine feasibility of the STAMP+CBT app	Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). Based on that patient's overall adherence rate/app retention rates will be calculated and intervention will be considered feasible if more than 70% of subjects complete complete any activity on the app at least 50% of days on study.	4-weeks
Primary	Proportion of patients who rate the acceptability items 4 or higher on the app.	Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). In response to the survey's patient will be assigned tailored psychological intervention for advanced cancer pain. During the trial, these interventions will be considered acceptable only if 80% or more of the acceptability items are rated 4 or higher/5; Lower rating will lead to app refinements.	6-weeks