Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain (STAMP+CBT)

University of Oklahoma (OU)

Status: Completed

Conditions: Cancer Pain; Cognitive Behavior Therapy; Opioid Use

Treatments: Behavioral: Cognitive Behavioral Therapy for pain

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05774197

1R21CA263838-01 (U.S. NIH Grant/Contract)

STAMP+CBT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

STAMP+CBT app

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for pain