STAMP+CBT App for Cancer Pain

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

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new phone app that helps people with cancer manage their pain. The app provides methods and tips for reducing pain through behavior changes. The study aims to see if the app is useful and easy to use 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.

Is the STAMP+CBT App for Cancer Pain safe for humans?

The mobile pain coping skills training (mPCST) intervention, similar to the STAMP+CBT App, has been found to be feasible, low burden, and acceptable to cancer patients, suggesting it is generally safe for use. ^{1 2 3 4 5}

How does the STAMP+CBT app treatment for cancer pain differ from other treatments?

The STAMP+CBT app is unique because it combines stress management and cognitive-behavioral therapy (CBT) in a mobile application, allowing patients to manage their cancer pain and associated symptoms at home. This integrated approach can reduce the need for frequent clinic visits and provides a personalized, step-by-step assessment and management of pain and stress. ^{6 7 8 9 10}

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

Research shows that mobile health technologies, like the STAMP+CBT app, can effectively teach cancer patients pain coping skills, leading to reduced pain severity and improved self-management. These mobile interventions are as effective as traditional in-person methods and are more accessible, making them a promising option for managing cancer pain. ^{1 4 5 11 12}

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

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]

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]

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]

Citations

1. 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]

2. 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]

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

Feasibility of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance in cancer. [2021]

4. 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]

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

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

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

Breakthrough Cancer Pain Influences General Activities and Pain Management: A Comparison of Patients with and without Breakthrough Cancer Pain. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Development and testing of a multidimensional iPhone pain assessment application for adolescents with cancer. [2022]

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

Pressure pain sensitivity as a marker for stress and pressure pain sensitivity-guided stress management in women with primary breast cancer. [2015]

9. United States 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. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Can we dream of an integrated pain management app for cancer patients? [2022]

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

The usefulness of a daily pain management diary for outpatients with cancer-related pain. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer rehabilitation approaches to neurologic pain syndromes in malignancy. [2014]