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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment STAMP + CBT for cancer pain?

Research shows that mobile pain coping skills training (mPCST), which is similar to STAMP + CBT, is effective in reducing pain severity and improving self-efficacy in cancer patients. Additionally, cognitive-behavioral therapy (CBT) tailored to patient characteristics has been shown to significantly improve pain management outcomes in cancer patients. ^{1 2 3 4 5}

Is the digital therapy for cancer pain safe for humans?

The studies suggest that mobile pain coping skills training (mPCST) is feasible, presents low burden to patients, and is acceptable, indicating it is generally safe for cancer patients with pain. ^{1 4 5 6 7}

How is the STAMP + CBT treatment for cancer pain different from other treatments?

STAMP + CBT is unique because it combines digital therapy with cognitive behavioral therapy (CBT) to manage cancer pain, making it more accessible and engaging for patients compared to traditional in-person therapies. This approach leverages mobile health technology to provide pain coping skills training remotely, which can be as effective as face-to-face sessions. ^{1 8 9 10 11}

Research Team

Desiree Azizoddine, PsyD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Tailoring cognitive-behavioral treatment for cancer pain. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

AAPT Diagnostic Criteria for Chronic Cancer Pain Conditions. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Predictors of Response to an Evidence-Based Behavioral Cancer Pain Management Intervention: An Exploratory Analysis From a Clinical Trial. [2021]

7. England 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Digital therapeutic to improve cancer-related well-being: a pilot randomized controlled trial. [2023]

9. England 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study Testing the Efficacy of dCBT in Patients With Cancer Experiencing Sleep Problems. [2022]

11. England pubmed.ncbi.nlm.nih.gov

A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery. [2023]