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Behavioral Intervention
Online Pain Coping Skills Training for Cancer Pain
N/A
Recruiting
Led By Donald B Penzien, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pain score ≥ 4 (PROMIS Pain Intensity (1a) scale) on "Most Days" or more (Graded Chronic Pain Scale)
Pain of new onset or significantly exacerbated since cancer diagnosis or initiation of cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 weeks, 18 weeks
Awards & highlights
Study Summary
This trial will assess the feasibility & acceptability of an 8-week online pain coping skills program for Spanish-speaking Hispanic/Latine cancer patients. Questions will measure pain levels before & after the program.
Who is the study for?
This trial is for Spanish-speaking Hispanic and Latine adults (18+) who have been treated for invasive cancer within the last 5 years. They must be experiencing new or worsened pain since their diagnosis or treatment, with a pain score of at least 4. Their pain medication regimen should be stable, but adjustments are allowed if unexpected.Check my eligibility
What is being tested?
The study tests an online program called 'painTRAINER' designed to help manage cancer-related pain over an 8-week course. It aims to determine how feasible and acceptable this program is for Spanish-speaking individuals in the Hispanic and Latine community.See study design
What are the potential side effects?
Since 'painTRAINER' is a non-medical intervention focusing on coping skills training, it does not have physical side effects like drugs do. However, participants may experience emotional discomfort when discussing their pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience significant pain most days.
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My pain started or got worse after my cancer diagnosis or treatment began.
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I have been treated for cancer with one or more types of therapy.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 10 weeks, 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 weeks, 18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
Adherence - percent of participants who complete the study modules as a measure of retention
Secondary outcome measures
Change in Cognitive Function scores
Change in Fatigue scores
Change in Pain interference scores
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: painTRAINER interventionExperimental Treatment1 Intervention
40 Spanish speaking Hispanic and Latine participants will participate in an 8 week online pain coping skills training program designed to address cancer-related pain.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
painTRAINER
2022
N/A
~30
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,690 Total Patients Enrolled
Donald B Penzien, PhDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor believes I can complete the study tasks and I'm mostly self-sufficient.I experience significant pain most days.My pain is not caused by my cancer or its treatment.My pain started or got worse after my cancer diagnosis or treatment began.I have been treated for cancer with one or more types of therapy.My cancer is stable, whether I'm on treatment or not.I have a disability that prevents me from completing study tasks.My pain medication dose has been stable; only unexpected changes are allowed.I am 18 years old or older.You have a known problem with using drugs or taking too many opioid medications.It has been 5 years or less since I finished my main cancer treatment.You are of Hispanic or Latine descent and can read and speak Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: painTRAINER intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the intended outcomes of this experiment?
"The primary objective of this clinical trial, to be evaluated over an 18 week interval, is the Acceptability rate - ie. what percentage of eligible participants screen and consent for participation? Secondary outcomes include: Change in Pain severity (as measured by the Brief Pain Inventory), Changes in Fatigue scores (via PROMIS questionnaire) and alteration in Sleep Disturbance scores (also via a PROMIS assessment). All metrics are registered on Likert scales ranking from low to high."
Answered by AI
Are there still opportunities to participate in this medical investigation?
"The data posted on clinicaltrials.gov affirms that this particular trial is not currently seeking participants, though the most recent edit to its details was performed on June 14th of 2023. Nonetheless, 40 other studies are actively recruiting at this time."
Answered by AI
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