Clinical trial NCT06722014: Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
Official title: Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Pain Syndrome
Advanced Cancer
Keywords: Pain
Pain Syndrome
Advanced Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain.

The name of the study smartphone application involved in this study is:

-STAMP+CBT

Detailed description: The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are standard care. The app is intended to improve self-management of cancer-related pain.

The study will begin with Cohort A, followed by Cohort B. These two cohorts are to refine the STAMP+CBT intervention. Then a randomized pilot will be performed, and participants will be randomized into one of two study groups for the pilot: Cohort C: STAMP+CBT versus Cohort D: Digital Cancer Pain Education Packet + Usual Care. Randomization means a participant is placed into a study group by chance.

It is expected that about 60 people will take part in this research study.

The National Institutes of Health, National Cancer Institute (NIH-NCI), is funding this research study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 22 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/palliative care
* Chronic pain related to cancer or treatment (\> pain score of 4 on a 0-10 scale)
* Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
* Own/use a compatible smartphone (iPhone or Android)

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 (e.g. delirium, dementia)
* Inability to speak English (the intervention has not yet been translated to Spanish)
* Currently in CBT treatment
* 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)
* Conditions that hinder smartphone use
* The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Primary outcomes:
measure: Overall intervention adherence rate (Cohort C)
timeFrame: Up to 4 weeks
measure: Overall intervention adherence rate (Cohort D)
timeFrame: Up to 4 weeks
measure: Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)
timeFrame: Up to 6 weeks
measure: Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Number of Enrolled Participants who Consented and Completed the Study (Cohort C)
timeFrame: 18 months
measure: Number of Enrolled Participants who Consented and Completed the Study (Cohort D)
timeFrame: 18 months
measure: Study Retention (Cohort C)
timeFrame: 18 months
measure: Study Retention (Cohort D)
timeFrame: 18 months
measure: Median assessment score on the system usability scale at 4 weeks (Cohort C)
timeFrame: Up to 6 weeks
measure: Median assessment score on the system usability scale at 4 weeks (Cohort D)
timeFrame: Up to 6 weeks
measure: Change in Brief Pain Inventory (BPI) Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort C)
timeFrame: Up to 6 weeks
measure: Change in BPI Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort D)
timeFrame: Up to 6 weeks
measure: Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort C)
timeFrame: Up to 6 weeks
measure: Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort D)
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Desiree Azizoddine, PsyD
role: PRINCIPAL_INVESTIGATOR
References: