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

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

Study Overview

• Status: Recruiting
• Conditions: Pain; Advanced Cancer; Pain Syndrome
• Intervention / Treatment: Behavioral: Digital Cancer Pain Education Packet; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Desiree Azizoddin, PsyD; Phone Number: 626-826-7984; Email: Desiree_Azizoddin@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Principal Investigator: Desiree R Azizoddin, PsyD
      • Contact: Desiree R Azizoddin, PsyD; Phone Number: 626-826-7984; Email: Desiree_Azizoddin@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort C: STAMP + CBT App; 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	Behavioral: STAMP + CBT; A mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback.; Other Names: Smartphone Technology to Alleviate Malignant Pain+Cognitive Behavioral Therapy for pain
Other: Cohort D: Digital Cancer Pain Education Packet + Usual Care; 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	Behavioral: Digital Cancer Pain Education Packet; Packet including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall intervention adherence rate (Cohort C)	>70% of subjects complete any activity on the STAMP+CBT application at least 50% of days on study (4-week study period). The app will be considered feasible if this benchmark is achieved.	Up to 4 weeks
Overall intervention adherence rate (Cohort D)	Defined as completion of the 14- and 28-days surveys, which assesses completion of the pain and medication monitoring reports by participants in the control group.	Up to 4 weeks
Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)	Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.	Up to 6 weeks
Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)	Acceptability of the intervention is defined as > 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Enrolled Participants who Consented and Completed the Study (Cohort C)	Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.	18 months
Number of Enrolled Participants who Consented and Completed the Study (Cohort D)	Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.	18 months
Study Retention (Cohort C)	Defined as the proportion of participants of the intervention group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.	18 months
Study Retention (Cohort D)	Defined as the proportion of participants of the control group on study for the complete study period. Subjects are defined as individuals who consented and enrolled to the trial and complete study measures and either 28 days of app use (intervention group) or 28 days of education packet review (control group). Rates of completion will be compared between the intervention and control groups.	18 months
Median assessment score on the system usability scale at 4 weeks (Cohort C)	Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. The survey at 4 weeks will assess intervention acceptability with the System Usability Scale (Brooke, 2002). The app will be considered usable if the median score on the System Usability Scale across respondents is >75.	Up to 6 weeks
Median assessment score on the system usability scale at 4 weeks (Cohort D)	Intervention usability will be assessed by the System Usability Scale (SUS), a 12-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. The survey at 4 weeks will assess control education packet acceptability with the System Usability Scale (Brooke, 2002). This information will be used to compare usability scores across intervention and control groups.	Up to 6 weeks
Change in Brief Pain Inventory (BPI) Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort C)	Assessed by the BPI, a 7-item subscale on pain interference with answers scored on a scale from 0 "Does not interfere" to 10 "Greatly interferes." A total scores range is 0 to 70 with a higher score indicating greater pain interference.	Up to 6 weeks
Change in BPI Pain Interference Score from Baseline to 4 and 6 Weeks (Cohort D)	Assessed by the BPI, a 7-item subscale on pain interference with answers scored on a scale from 0 "Does not interfere" to 10 "Greatly interferes." A total scores range is 0 to 70 with a higher score indicating greater pain interference.	Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort C)	Assessed by the Brief Pain Inventory (BPI) pain intensity subscale, a 4-item measure on pain intensity with answers scored on a scale from 0 "No pain" to 10 "Pain as bad as you can imagine." A total scores range is 0 to 40 with a higher score indicating greater pain intensity.	Up to 6 weeks
Change in BPI Pain Intensity Score from Baseline to 4 and 6 Weeks (Cohort D)	Assessed by the Brief Pain Inventory (BPI) pain intensity subscale, a 4-item measure on pain intensity with answers scored on a scale from 0 "No pain" to 10 "Pain as bad as you can imagine." A total scores range is 0 to 40 with a higher score indicating greater pain intensity.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Desiree Azizoddine, PsyD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Advanced Cancer; Pain Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms; Chronic Pain
• Other Study ID Numbers: 24-286; 5K08CA266937 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No