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mHealth Behavioral Intervention for Cancer Pain in Breast Cancer (ICAN-NC Trial)

N/A

Waitlist Available

Led By Tamara J Somers, Ph.D.

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reporting experiencing pain on at least 10 days in the last month and rating their pain in the past week as a 4 or greater on a 0-10 scale. The combination of these items assesses the patient's level of persistent pain (in the last month) and pain severity with an accurate recall period (i.e., last week; >4).

Women with a diagnosis of any breast cancer within the last three years

Must not have

Brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether an innovative mobile health Pain Coping Skills Training (mPCST-Community) intervention designed to meet the needs of breast cancer patients with pain in medically underserved areas is efficacious in reducing pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention is non-pharmacological focusing on coping skills via technology, traditional medication side effects aren't expected. However, participants may experience discomfort from discussing personal experiences or fatigue from engaging with the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Interference

Change in Physical Disability

Change in fatigue

+1 more

Secondary study objectives

Change in Pain Catastrophizing

Change in Self-Efficacy for pain control

Cost-Effectiveness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mobile Health Pain Coping Skills Training (mPCST)Experimental Treatment1 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 Control1 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.

0 / 4Eligibility criteria met