Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

NCT05774197 | Completed Results

• 2 other identifiers: STAMP+CBT1R21CA263838-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Pain; Opioid Use; Cognitive Behavior Therapy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6-weeks

Study Arms (1)

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.

Behavioral: Cognitive Behavioral Therapy for pain

Interventions

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).

STAMP+CBT app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Cancer Pain; Color Vision Defects

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Desiree Azizoddin, PsyD
• Organization: Harvard Medical School

desiree_azizoddin@dfci.harvard.edu

4052718001

Study Officials

• Desiree Azizoddin, PsyD

  Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 17, 2023
• Study Start: May 4, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: November 4, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)