Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

Trial Title: Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

NCT ID: NCT05774197

Condition: Cancer Pain
Opioid Use
Cognitive Behavior Therapy

Conditions: Official terms:
Cancer Pain

Conditions: Keywords:
STAMP (Smartphone Technology to Alleviate Malignant Pain)
CBT (Cognitive Behavioral Therapy)
mHealth (Mobile Health technology)

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Cognitive Behavioral Therapy for pain
Description: 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).
Arm group label: STAMP+CBT app

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.

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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73117
Country: United States

Status: Recruiting

Contact:
Last name: Desiree Azizoddin, PsyD

Phone: 405-271-8001

Phone ext: 50516
Email: Desiree-Azizoddin@ouhsc.edu

Start date: May 4, 2023

Completion date: July 2025

Lead sponsor:
Agency: University of Oklahoma
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Oklahoma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05774197