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Completed

NCT Number: NCT05774197

Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

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.

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Key information

Conditions

Cancer Pain Cognitive Behavior Therapy Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Pain

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: STAMP+CBT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2023
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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