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Behavioral Intervention

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

N/A

Waitlist Available

Led By Desiree Azizoddine, PsyD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months, based on total accrual duration

Awards & highlights

No Placebo-Only Group

Summary

Smartphone Technology to Alleviate Malignant Pain (STAMP) The purpose of the study is to develop and refine the Smartphone Technology to Alleviate Malignant Pain (STAMP) application 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

Eligible Conditions

Pain
Complex Regional Pain Syndrome
Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months, based on total accrual duration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months, based on total accrual duration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months, based on total accrual duration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Application Utilization Time (Cohort C)

Completion Rate of App-Delivered Content (Cohort C)

Retention Rate (Cohort C)

+4 more

Secondary study objectives

Change in Acceptability E-Scale Score from Baseline to 4 Weeks (Cohort C)

Change in Acceptability E-Scale Score from Baseline to 4 Weeks (Cohort D)

Change in Acceptability E-Scale Score from Baseline to 6 Weeks (Cohort C)

+23 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort D: Digital Cancer Pain Education Packet + Usual CareExperimental Treatment1 Intervention

Permutated-block randomization and a block size of 6 will be used to randomize 30 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

Group II: Cohort C: STAMP + CBT AppExperimental Treatment1 Intervention

Permutated-block randomization and a block size of 6 will be used to randomize 30 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

Group III: Cohort B: Pre-Pilot TestingExperimental Treatment1 Intervention

8 participants will be enrolled for this cohort and will engage in a 4-week testing period of the intervention followed by a one-time interview with study staff.

Group IV: Cohort A: User Acceptability TestingExperimental Treatment1 Intervention

15 participants will be enrolled for this cohort. Participants will engage in a one-time interview with study staff or a focus group with other participants. Application testing and user acceptability testing will be completed by participants to provide feedback for refining the intervention.

0 / 5Eligibility criteria met