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

N/A

Recruiting

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

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

ICAN-NC Trial 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.Check my eligibility

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.See study design

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.

ICAN-NC Trial 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.

ICAN-NC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain Interference

Change in Physical Disability

Change in fatigue

+1 more

Secondary outcome measures

Change in Pain Catastrophizing

Change in Self-Efficacy for pain control

Cost-Effectiveness

ICAN-NC 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,306 Total Patients Enrolled

54 Trials studying Breast Cancer

10,031 Patients Enrolled for Breast Cancer

Tamara J Somers, Ph.D.Principal InvestigatorDuke University

2 Previous Clinical Trials

367 Total Patients Enrolled

1 Trials studying Breast Cancer

40 Patients Enrolled for Breast Cancer

Media Library

Mobile Health Pain Coping Skills Training (mPCST) Clinical Trial Eligibility Overview. Trial Name: NCT04175639 — N/A

Breast Cancer Research Study Groups: mHealth-Education (mHealth-Ed), Mobile Health Pain Coping Skills Training (mPCST)

Breast Cancer Clinical Trial 2023: Mobile Health Pain Coping Skills Training (mPCST) Highlights & Side Effects. Trial Name: NCT04175639 — N/A

Mobile Health Pain Coping Skills Training (mPCST) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175639 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial currently recruiting?

"Affirmative. On clinicaltrials.gov, the details of this research study are currently available for review; it was initially posted on October 20th 2021 and freshly updated on September 22nd 2022. The trial is seeking 180 patients at a single medical site."

Answered by AI

Is participation in this clinical research open to octogenarians?

"This clinical trial is exclusively open to adults between the ages of 18 and 99. Moreover, there are 53 trials available for individuals younger than 18 while 1370 opportunities exist for seniors older than 65 years old."

Answered by AI

Do I satisfy the criteria to join this experiment?

"This clinical trial has a recruitment goal of 180 individuals, ranging from 18 to 99 years old, who have been diagnosed with breast cancer in the last three years. Additional requirements include having a life expectancy of more than 12 months and reporting experiencing at least 10 days of pain within the month prior as well as rating their current level of discomfort on a scale from 0-10 with 4 being the minimum threshold. These selection criteria will identify those that suffer from persistent pain assessed over an accurate recollection period (i.e., past week; >4)."

Answered by AI

Are there any opportunities for individuals to participate in this experiment?

"According to the details provided on clinicaltrials.gov, this study is actively seeking qualified participants. It was first listed online in October of 2021 and recently updated in September 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients

2021. "mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175639.

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