Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Advanced Cancer; Pain Syndrome; Pain

Treatments: Behavioral: Digital Cancer Pain Education Packet; Behavioral: STAMP + CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06722014

24-286

5K08CA266937 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort C: STAMP + CBT App

Experimental group

Description:

Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with an introduction to the STAMP+CBT application. * Surveys via the application 6 days per week. * Day 7 check in with study team * Day 14 survey * Day 28 follow-up surveys * Optional in-person or remote semi-structured, exit interview * Day 42 (Week 6) follow-up survey

Treatment:

Behavioral: STAMP + CBT

Cohort D: Digital Cancer Pain Education Packet + Usual Care

Other group

Description:

Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with introduction to the digital cancer pain education packet and pain tracker form. * Completion of pain tracker * Day 7 check in with study team * Day 14 survey * Day 28 surveys * Optional in-person or remote semi-structured, exit interview to review the educational packet * Day 42 (Week 6) follow-up survey

Treatment:

Behavioral: Digital Cancer Pain Education Packet