Digital Therapy for Cancer Pain

Overseen By Desiree Azizoddin, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Opioids

Must not be taking: Transmucosal fentanyl

Disqualifiers: Survivorship, Cognitive impairment, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app designed to help manage pain in people with advanced cancer. The app combines psychological support, such as cognitive behavioral therapy (CBT), with traditional pain medication management. It suits those dealing with cancer-related pain, using an opioid prescription, and owning a smartphone. Participants will use the app to track their pain and receive support over several weeks. The goal is to determine if this digital approach can effectively reduce cancer pain. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions for cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have an active prescription for at least one opioid medication for cancer pain. You cannot participate if you use transmucosal fentanyl.

What prior data suggests that the STAMP+CBT app is safe for alleviating cancer pain?

Research has shown that the STAMP+CBT app is safe and easy for users to handle. In past studies, the app proved to be a practical way to help treat cancer pain. More than 70% of participants used the app without major problems. By combining pain management with psychological support, the app remains user-friendly for most people. Earlier tests reported no significant negative effects or side effects, suggesting that the app is a safe option for managing cancer pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Therapy for Cancer Pain trial because it explores innovative ways to manage cancer-related discomfort beyond traditional medication. Unlike common treatments like opioids and NSAIDs, the STAMP + CBT app combines digital pain management with cognitive-behavioral therapy, offering an interactive, tech-based solution that empowers patients to actively participate in their pain management. Additionally, the trial's comparison with a digital cancer pain education packet aims to determine the efficacy of comprehensive digital education in enhancing usual care practices. This trial could pave the way for more personalized and less pharmacologically dependent approaches to cancer pain management.

What evidence suggests that the STAMP+CBT app is effective for alleviating cancer pain?

Research has shown that the STAMP+CBT app, available to participants in this trial, is a promising tool for managing pain in people with advanced cancer. The app offers lessons on pain management and mental health education, along with tools to track mood and opioid use. Previous studies found it both acceptable and practical for patients. Early findings suggest that STAMP+CBT may enhance pain management by integrating psychological and medicine-based support. This combination aims to provide users with a comprehensive approach to managing their cancer pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Desiree Azizoddine, PsyD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 22 with chronic pain from advanced cancer, who use a smartphone and take opioid medication for cancer pain. It's not for those who don't speak English, have cognitive issues, are hospitalized or in hospice care, currently in CBT treatment, or whose pain is from recent surgery.

Inclusion Criteria

I am 22 years old or older.

I experience chronic pain from cancer or its treatment, with a pain level above 4.

I am currently being treated for an advanced cancer or receiving care to ease cancer symptoms.

Exclusion Criteria

I can communicate effectively in English.

Conditions that hinder smartphone use

I have completed my cancer treatment and am not currently receiving treatment for advanced cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development and Refinement

Development and refinement of the STAMP+CBT app with feedback from Cohort A and B

4 weeks

Baseline visit (in-person or remote), daily app surveys, weekly check-ins

Randomized Pilot

Participants are randomized into Cohort C or D to test the STAMP+CBT app or Digital Cancer Pain Education Packet

6 weeks

Baseline visit, Day 7 check-in, Day 14 survey, Day 28 follow-up surveys, Day 42 follow-up survey

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STAMP + CBT

Trial Overview The STAMP+CBT mobile app is being tested to see if it can help manage cancer-related chronic pain by combining psychological support (CBT) with guidance on using pain medications effectively through a digital platform.

How Is the Trial Designed?

Group I: Cohort D: Digital Cancer Pain Education Packet + Usual Care Experimental Treatment 1 Intervention

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

Group II: Cohort C: STAMP + CBT App Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 178 cancer patients undergoing pain coping skills training (PCST), 34% experienced significant reductions in pain severity and 46% in pain interference, highlighting the intervention's effectiveness.

Factors such as education level, cancer type, and marital status influenced the likelihood of experiencing pain relief, suggesting that tailored approaches could enhance the benefits of PCST for different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. Check, DK., Winger, JG., Jones, KA., et al.[2021]

A pilot study with 30 cancer patients showed that mobile pain coping skills training (mPCST) delivered via Skype is feasible and has low burden on patients, leading to high engagement and acceptability.

Patients using mPCST experienced significant reductions in pain severity and improved self-efficacy for pain management, with results comparable to those receiving traditional in-person training, indicating that mPCST can be an effective alternative for managing cancer pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain. Somers, TJ., Kelleher, SA., Westbrook, KW., et al.[2020]

Meaning-Centered Pain Coping Skills Training (MCPC) is a feasible and effective intervention for managing pain in patients with advanced cancer, showing significant improvements in pain severity and self-efficacy after 10 weeks.

In a study of 60 adults with stage IV solid tumors, those receiving MCPC reported better pain management outcomes compared to usual care, with moderate-to-large effect sizes in pain severity and interference, indicating its potential as a valuable addition to standard pain management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. Winger, JG., Kelleher, SA., Ramos, K., et al.[2023]

Mobile health pain coping skills training (mPCST) is significantly more feasible than traditional in-person pain coping skills training (PCST-traditional), making it easier for cancer patients to access and complete the program.

Both mPCST and PCST-traditional showed similar effectiveness in reducing pain severity and interference, indicating that mPCST is a viable alternative to traditional methods for managing cancer-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. Kelleher, SA., Winger, JG., Dorfman, CS., et al.[2023]

A phase 2 clinical trial involving 120 primary brain tumor patients aims to assess the feasibility of a remote virtual reality (VR) relaxation intervention to help reduce distress and anxiety, particularly during the stressful period before MRI scans.

The study will evaluate the preliminary efficacy of the VR intervention in improving psychological symptoms, with follow-up assessments conducted immediately after the intervention and at 1 and 4 weeks, potentially paving the way for larger trials in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. King, AL., Acquaye-Mallory, AA., Vera, E., et al.[2023]

The pilot study involving 57 cancer patients demonstrated that the digital cognitive behavioral therapy (dCBT) program, HARUToday Sleep, significantly improved sleep quality compared to both an app-based control and a waitlist group, indicating its efficacy as an intervention.

Despite the improvements in sleep quality, the study found no significant changes in overall health-related quality of life or attentional bias, suggesting that while HARUToday Sleep is effective for sleep issues, it may not impact other areas of well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Testing the Efficacy of dCBT in Patients With Cancer Experiencing Sleep Problems. Chung, KM., Suh, YJ., Chin, S., et al.[2022]

An 8-week web-based pain coping skills training (PCST) program was found to be highly acceptable to cancer patients, providing both emotional and physical benefits, which could improve pain management for those with cancer-related bone pain.

Healthcare providers expressed support for the web-based PCST program, suggesting that it could be effectively integrated into clinical care if barriers such as provider familiarity and patient workload are addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain. Rini, C., Vu, MB., Lerner, H., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38252172/

Development and pre-pilot testing of STAMP + CBT - PubMed The STAMP + CBT app was an acceptable and feasible method to deliver psychological/behavioral treatment with pharmacologic support for cancer pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05774197

Psychological Intervention Using Smartphone Technology ... 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 ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04363

Evaluating the STAMP+CBT Mobile Application for ... This study may help researchers learn whether the STAMP+CBT is useful for improving pain management in patients with advanced cancer and pain. Eligibility ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11088794/

Development and pre-pilot testing of STAMP + CBT The app delivers brief daily lessons from pain-CBT and pain psychoeducation, adapted for advanced cancer. Daily surveys assess physical symptoms ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT428036

Feasibility and acceptability of an mHealth app integrating ... Conclusions: The STAMP+CBT app was an acceptable and feasible method to integrate and deliver psychological/behavioral treatment with opioid support to support ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06722014

Integrating Pain-CBT Into an mHealth Analgesic Support ... 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 ...

7. withpower.com withpower.com/trial/phase-palliative-care-9-2022-38927

STAMP+CBT App for Cancer Pain · Info for Participants Research shows that the STAMP+CBT app is helpful and easy to use for people with cancer pain. In earlier studies, over 70% of participants used the app ...