STAMP+CBT App for Cancer Pain

No longer recruiting at 2 trial locations

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, Hospice, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help people manage cancer-related pain. The app combines two approaches: STAMP (a method to manage pain) and CBT (cognitive-behavioral therapy, which helps change negative thought patterns). The researchers aim to determine if this app can improve pain management for cancer patients. Ideal participants are those actively receiving cancer treatment, experiencing chronic pain, and already using opioid medication for this pain. Participants must own or be willing to use an Android smartphone for the study.

As an unphased trial, this study allows participants to contribute to innovative pain management solutions that could benefit many in the future.

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 this application is safe for cancer patients?

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 regularly for four weeks, indicating that most users found it easy to use and were willing to continue. Additionally, similar treatments like Cognitive Behavioral Therapy (CBT), which the app includes, have been proven to safely reduce pain and improve daily life for adults with complex pain. These results suggest that the app is generally well-received and does not present major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STAMP+CBT app for cancer pain because it offers a unique approach by combining digital technology with cognitive-behavioral therapy (CBT). Unlike traditional pain management methods that often rely on medications like opioids or over-the-counter pain relievers, this app empowers patients to actively participate in their pain management through psychological techniques. The app is designed for easy access and consistent use over a 4-week period, providing personalized interventions and tracking progress via surveys. This makes it a potentially safer, more engaging, and convenient option for managing cancer pain compared to standard pharmaceutical treatments.

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

Research has shown that the STAMP+CBT app, which participants in this trial will use, is a promising tool for managing cancer pain. Early studies indicate that it is both easy to use and effective in providing psychological and behavioral treatment alongside medication support. This app combines cognitive behavioral therapy (a type of talk therapy) with opioid support to help patients manage pain. Initial findings suggest that this method could significantly improve pain management for those with cancer. It offers a straightforward way for patients to control their pain at home. ^{2 3 6 7 8}

Who Is on the Research Team?

Desiree Azizoddin, PsyD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic pain from cancer or its treatment, who are being treated at specific clinics and have a smartphone. They must be undergoing active cancer treatment or palliative care, have a pain score over 4, and take opioids for cancer pain (not post-surgical). Excluded are non-English speakers, hospitalized patients, those in remission or survivorship phase, with cognitive impairments, history of opioid misuse, enrolled in hospice or using transmucosal fentanyl.

Inclusion Criteria

Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry)

Own a compatible smartphone (android) or is willing to use an android device provided by the study team

Completes baseline survey

Exclusion Criteria

You have pain mostly from a recent surgery.

You are not currently receiving treatment for advanced cancer, or your cancer is in remission.

You have trouble thinking or remembering things that may affect your ability to take part in the study, according to your doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Intervention

Participants use the smartphone app and complete surveys at baseline and after 4 weeks

4 weeks

Surveys at baseline and 4 weeks

Post-intervention

Participants complete a survey at the end of the 2-week post-intervention period

2 weeks

Survey at 6 weeks

Follow-up

Participants are monitored for feedback and overall acceptability of the app

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STAMP+CBT application

Trial Overview The study tests an mHealth app called STAMP+CBT designed to assist patients managing cancer-related chronic pain. The effectiveness of the mobile application in improving patient outcomes will be evaluated among participants who meet the criteria.

How Is the Trial Designed?

Group I: STAMP+CBT PILOT Experimental Treatment 1 Intervention

Patients in this Pilot Cohort will be in the research study for 6 weeks total including: * a 4-week intervention period and 2-week post intervention period. * Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period).

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Palliative Care Research Center

Collaborator

Trials

3

Recruited

190+

National Palliative Care Research Center (NPCRC)

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

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]

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]

The Meaning-Centered Pain Coping Skills Training (MCPC) intervention was found to be feasible and acceptable for 30 participants with stage IV cancer, with a high completion rate of 90% for intervention sessions and 87% for post-intervention assessments.

Participants reported significant improvements in pain severity, pain interference, and spiritual well-being after the intervention, along with high satisfaction levels, indicating that MCPC could be a beneficial approach for managing pain in advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. Winger, JG., Ramos, K., Kelleher, SA., et al.[2023]

The Pain Squad app, designed for adolescents with cancer, effectively collects detailed pain data and has shown high compliance rates of 81% during a 2-week feasibility trial, indicating its usability and acceptance among users.

The app's game-based design and reward system were particularly appealing to adolescents, contributing to their satisfaction and consistent use, which is crucial for better pain management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a multidimensional iPhone pain assessment application for adolescents with cancer. Stinson, JN., Jibb, LA., Nguyen, C., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.418

Development of an mHealth app integrating pain-cognitive ... Development of an mHealth app integrating pain-cognitive behavioral therapy and opioid support for patients with advanced cancer (STAMP+CBT).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05403801

Study Details | STAMP+CBT mHealth for Cancer Pain This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.

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

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

4. 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 ...

5. reporter.nih.gov reporter.nih.gov/project-details/11105914

Project Details - NIH RePORTER This integrated psychological and pharmacologic mHealth intervention has strong potential to improve cancer pain outcomes and to readily disseminate pain ...

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

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

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... MBT and CBT were associated with safe improvements in pain and functional outcomes among adults affected with refractory, complex, opioid- ...

8. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00258

Beyond Opioids: A Multidisciplinary Approach to Cancer ... The app also provides extensive pain cognitive behavioral therapy education tailored to the cancer experience. ... STAMP + CBT mHealth app content.