180 Participants Needed

mHealth Behavioral Intervention for Cancer Pain in Breast Cancer

(ICAN-NC Trial)

TJ
Overseen ByTamara J Somers, Ph.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients' community based oncology clinic by a remote therapist, is extended to the patients' home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team's extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is expected that mPCST-Community will lead to decreased pain as well as fatigue, disability, and distress compared to mHealth-Ed. For Aim 2, it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing. For Aim 3, it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use, participant and therapist time, and health utilities as well as successful overall accrual, high subject retention, and high intervention adherence.

Who Is on the Research Team?

TJ

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.
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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.
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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?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
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Recruited
5,912,000+
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