Back to resultsPsychological Intervention Using Smartphone Technology to Alleviate Malignant Pain (STAMP+CBT)
Primary Purpose
Cancer Pain, Opioid Use, Cognitive Behavior Therapy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for pain
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Pain focused on measuring STAMP (Smartphone Technology to Alleviate Malignant Pain), CBT (Cognitive Behavioral Therapy), mHealth (Mobile Health technology)
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.
Sites / Locations
- University of Oklahoma Health Sciences CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STAMP+CBT app
Arm 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.
Outcomes
Primary Outcome Measures
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 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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05774197
First Posted
February 15, 2023
Last Updated
October 4, 2023
Sponsor
University of Oklahoma
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05774197
Brief Title
Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain
Acronym
STAMP+CBT
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Opioid Use, Cognitive Behavior Therapy
Keywords
STAMP (Smartphone Technology to Alleviate Malignant Pain), CBT (Cognitive Behavioral Therapy), mHealth (Mobile Health technology)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STAMP+CBT app
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for pain
Intervention 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).
Primary Outcome Measure Information:
Title
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
Description
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 complete any activity on the app at least 50% of days on study.
Time Frame
4-weeks
Title
Proportion of patients who rate the acceptability items 4 or higher on the app.
Description
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.
Time Frame
6-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Desiree Azizoddin, PsyD
Phone
405.271.8001
Ext
50516
Email
Desiree-Azizoddin@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desiree Azizoddin, PsyD
Organizational Affiliation
Stephenson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desiree Azizoddin, PsyD
Phone
405-271-8001
Ext
50516
Email
Desiree-Azizoddin@ouhsc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain
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