Clinical trial NCT05774197: Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain
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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Opioid Use
Cognitive Behavior Therapy
Keywords: STAMP (Smartphone Technology to Alleviate Malignant Pain)
CBT (Cognitive Behavioral Therapy)
mHealth (Mobile Health technology)
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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).

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.

Primary outcomes:
measure: 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
timeFrame: 4-weeks
measure: Proportion of patients who rate the acceptability items 4 or higher on the app.
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Stephenson Cancer Center
name: Desiree Azizoddin, PsyD
role: PRINCIPAL_INVESTIGATOR
References: