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Cognitive Behavioral Therapy App for Cancer Pain (STAMP+CBT Trial)
N/A
Recruiting
Led By Desiree Azizoddin, PsyD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
Chronic pain related to cancer or treatment (> pain score of 4)
Must not have
Currently hospitalized
Adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the STAMP+CBT app, a smartphone tool for advanced cancer patients to manage pain and mood. It tracks health metrics and provides personalized advice and educational content to improve pain management.
Who is the study for?
This trial is for adults over 18 with advanced cancer experiencing chronic pain (pain score >4) and using opioids to manage it. They must be undergoing treatment or receiving supportive care, not in remission, hospice, or hospitalized. Excludes those with cognitive impairments affecting participation, non-English speakers, recent surgery patients, and individuals under opioid risk mitigation programs.
What is being tested?
The study tests a new smartphone app called STAMP+CBT designed to help track pain levels, mood changes, opioid use and side effects while providing personalized education and self-management tips for managing cancer-related pain.
What are the potential side effects?
Since this intervention involves Cognitive Behavioral Therapy via an app rather than medication or invasive procedures, the side effects are minimal but may include discomfort from confronting painful emotions or stress related to tracking one's condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently prescribed opioids for my cancer pain.
Select...
My cancer or its treatment causes me significant pain.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently in the hospital.
Select...
I am an adult capable of giving consent, not pregnant, and not incarcerated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Proportion of patients who rate the acceptability items 4 or higher on the app.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: STAMP+CBT appExperimental Treatment1 Intervention
This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms.
Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder (OUD) include pharmacological and psychological interventions. Medications like methadone and buprenorphine bind to opioid receptors in the brain, reducing cravings and withdrawal symptoms without producing a high, while naltrexone blocks these receptors to prevent euphoria from opioid use.
Psychological treatments such as Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) focus on changing behaviors and thought patterns related to substance use. These treatments are essential for OUD patients as they address both physical dependence and psychological factors, enhancing overall treatment effectiveness.
The STAMP+CBT app exemplifies an integrated approach by tracking pain, mood, opioid use, and side effects, while delivering tailored education and self-management advice.
Systematic review on the clinical management of chronic pain and comorbid opioid use disorder.Opioid use by patients in an orthopedics spine clinic.
Systematic review on the clinical management of chronic pain and comorbid opioid use disorder.Opioid use by patients in an orthopedics spine clinic.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,621 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,393 Total Patients Enrolled
Desiree Azizoddin, PsyDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently prescribed opioids for my cancer pain.You are currently receiving hospice care.I am an adult capable of giving consent, not pregnant, and not incarcerated.I have an advanced cancer diagnosis and am currently receiving treatment or supportive care.My main pain is from a surgery I had within the last 2 weeks.I can communicate effectively in English.My cancer or its treatment causes me significant pain.I am currently in the hospital.I am not using fentanyl in a form that is absorbed through the mouth's lining.I am 18 years old or older.I have completed my cancer treatment and am not currently receiving treatment for advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: STAMP+CBT app
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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