Cancer PainSTAMP+CBTNCT05774197
Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain
A study testing Cognitive Behavioral Therapy for pain in people with Cancer Pain and Opioid Use, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Opioid Use, Cognitive Behavior Therapy
- What is being tested?
- Cognitive Behavioral Therapy for pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
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)
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.
Read the detailed 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).
- Conditions
- Cancer Pain, Opioid Use, Cognitive Behavior Therapy
- Being tested
- Cognitive Behavioral Therapy for pain
- Keywords
- STAMP (Smartphone Technology to Alleviate Malignant Pain), CBT (Cognitive Behavioral Therapy), mHealth (Mobile Health technology)
- Medical subject headings
- Cancer Pain, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for painBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| STAMP+CBT app | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 any activity on the app at least 50% of days on study.
Measured: 4-weeks
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.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start4 May 2023
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The STAMP+CBT application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. The primary objective is to determine the feasibility and acceptability during the 6-week study of the STAMP+CBT app (4-week intervention period and a 2-week post intervention period). Specifically, in this study 35 patients are enrolled and will be evaluated for their adherence to daily and weekly comprehensive symptom based self-assessments within the STAMP+CBT app.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Desiree Azizoddin, PsyD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774197
- Sponsor's protocol ID
- STAMP+CBT
- Other IDs
- 1R21CA263838-01
- Acronym
- STAMP+CBT
- Status last verified
- Oct 2025
- First submitted
- 15 Feb 2023
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05774197
- Acronym / sponsor ID
- STAMP+CBT / STAMP+CBT
- Conditions
- Cancer Pain, Opioid Use, Cognitive Behavior Therapy
- Keywords
- STAMP (Smartphone Technology to Alleviate Malignant Pain), CBT (Cognitive Behavioral Therapy), mHealth (Mobile Health technology)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 9 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The STAMP+CBT application uses multi-media educational materials and survey algorithms assessing pain, medication usage, mood, stress, and sleep to improve pain management in this population. The primary objective is to determine the feasibility and acceptability during the 6-week study of the STAMP+CBT app (4-week intervention period and a 2-week post intervention period). Specifically, in this study 35 patients are enrolled and will be evaluated for their adherence to daily and weekly comprehensive symptom based self-assessments within the STAMP+CBT app.
| Arm | Type | Receives |
|---|---|---|
| STAMP+CBT app | Experimental | Behavioral: Cognitive Behavioral Therapy for painThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for painPatient 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). | Behavioural | STAMP+CBT app |
Primary outcome
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
Time frame: 4-weeks
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 any activity on the app at least 50% of days on study.
Proportion of Patients Who Rate the Acceptability Items 4 or Higher on the App.
Time frame: 6-weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer Pain
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desiree Azizoddin, PsyD principal investigator
Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for pain in people with Cancer Pain and Opioid Use, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.