mHealth Behavioral Intervention for Cancer Pain in Breast Cancer

(ICAN-NC Trial)

Overseen By Tamara J Somers, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Brain metastases, Severe psychiatric condition, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mobile health program designed to help breast cancer patients manage pain without medication. It teaches pain coping skills through video sessions and mobile technology, making it more accessible for those in underserved areas. The main goal is to determine if this method can reduce pain, fatigue, and stress compared to standard health education. Women who have had breast cancer in the last three years and experience frequent significant pain are ideal candidates for this trial. Participants will be randomly assigned to either the Mobile Health Pain Coping Skills Training (mPCST) group or the standard education group. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could enhance quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a non-drug approach to managing pain, so it's likely you can continue your current medications, but you should confirm with the study team.

What prior data suggests that this mHealth behavioral intervention is safe for breast cancer patients?

Research has shown that Mobile Health Pain Coping Skills Training (mPCST) is generally safe and well-received by people with cancer-related pain. In past studies, mPCST helped patients feel less pain and manage it better. These studies included patients with various types of cancer, such as breast cancer, and reported positive results without major side effects.

For example, a small study with breast cancer patients found that a similar mPCST method improved their pain management and coping skills, with no serious negative effects. Another study demonstrated that patients who participated in a five-session pain coping skills training experienced less pain and felt more confident in handling it, again with no major safety issues.

Overall, the evidence suggests that mPCST is a safe way to manage pain in cancer patients, offering clear benefits with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Pain Coping Skills Training (mPCST) because it offers a fresh approach to managing persistent pain in breast cancer survivors. Unlike traditional pain management methods that often rely on medications, mPCST utilizes a digital platform to teach pain coping skills. This method empowers patients by enhancing their ability to self-monitor symptoms and adhere to lifestyle recommendations. The tele-video-conferencing format also provides convenient access to personalized support, making it a promising alternative for those seeking non-pharmacological pain relief.

What evidence suggests that this mHealth intervention is effective for reducing cancer pain in breast cancer patients?

Research has shown that learning skills to cope with pain can help reduce pain in cancer patients. In this trial, participants will join different treatment arms. One arm will receive Mobile Health Pain Coping Skills Training (mPCST), which past studies have shown helps patients report less pain, fewer physical symptoms, and greater confidence in managing their pain. Another study found that mPCST improved pain control and coping abilities. Delivered through mobile devices, this method aims to make pain management more accessible, especially for people in areas with fewer resources. Overall, mPCST seems promising in helping breast cancer patients manage their pain better. ^{2 5 6 7 8}

Who Is on the Research Team?

Tamara J Somers, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for women over 18 with any breast cancer diagnosis in the last three years, who have a life expectancy of more than 12 months and are experiencing significant pain. It's not suitable for those with severe psychiatric conditions, brain metastases, cognitive impairment, or recent participation in similar pain coping skills training.

Inclusion Criteria

I have had pain on most days in the last month and it's been severe this past week.

I was diagnosed with breast cancer in the last three years.

You are expected to live for more than 12 months.

Exclusion Criteria

Presence of a severe psychiatric condition or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or medical/study staff interactions

My cancer has spread to my brain.

You have trouble with memory or thinking, as shown by a test score below 25.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the mPCST-Community intervention or mHealth-Education control over 8 weeks with video-conferencing sessions

8 weeks

4 sessions (tele-video-conferencing)

Follow-up

Participants are monitored for changes in pain severity, physical disability, and other outcomes post-intervention

6 months

Assessments at post-intervention, 3-month, and 6-month

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Health Pain Coping Skills Training (mPCST)

Trial Overview The study tests an mHealth behavioral intervention called mPCST-Community to reduce pain and disability using video-conferencing and mobile technology. Participants will either receive this intervention or join a control group receiving mHealth education to compare effectiveness.

How Is the Trial Designed?

Group I: Mobile Health Pain Coping Skills Training (mPCST) Experimental Treatment 1 Intervention

Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).

Group II: mHealth-Education (mHealth-Ed) Active Control 1 Intervention

mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885392415002353

A Pilot Study of a Mobile Health Pain Coping Skills ... Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5116348/

A Small Randomized Controlled Pilot Trial Comparing ... Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management ...

3. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00445-1/fulltext

Effect of Pain Coping Skills Training on ... Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits.

4. formative.jmir.org formative.jmir.org/2024/1/e51021

Support for Chronic Pain Management for Breast Cancer ... This pilot study aims to evaluate patients' experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named ...

5. jpain.org jpain.org/article/S1526-5900(23)00414-5/fulltext

Cost-Effectiveness Analysis Evaluating Delivery Strategies ... Pain coping skills training (PCST) is efficacious in patients with cancer, but clinical access is limited.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4592787/

A Pilot Study of a Mobile Health Pain Coping Skills ... Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392423004451

Effect of Pain Coping Skills Training on Pain and ... Both conditions led to improvements in pain, pain medication use, pain self-efficacy, and coping skills use, and 5-session PCST showed the greatest benefits.

8. jpsmjournal.com jpsmjournal.com/article/S0885-3924(15)00235-3/pdf

A Pilot Study of a Mobile Health Pain Coping Skills ... Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain (N = 25) participated in a four-session ...