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Behavioral Intervention

Mobile App Intervention for Pain Management in Colorectal Cancer Patients

N/A

Recruiting

Led By Sarah A Kelleher, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

This trial is using tech & data to improve access to interventions & outcomes for people with pain. It could predict pain & push interventions to improve care. Data gathered will be used to bypass traditional trials & move quickly to a large effectiveness trial.

Who is the study for?

This trial is for adults over 18 with any stage of colorectal cancer. It's not suitable for those with cognitive impairments, brain metastases, severe psychiatric conditions like psychosis, or anyone who has participated in behavioral pain management recently.Check my eligibility

What is being tested?

PainPac is a mobile app designed to help manage pain in outpatient oncology settings by integrating with healthcare systems and EMRs. It uses real-time data from patients and biological sources to tailor interventions and improve care outcomes.See study design

What are the potential side effects?

Since PainPac is a non-pharmacological intervention focusing on coping strategies through an app, it may not have direct side effects like medications do. However, users could experience frustration if technical issues arise or if they find the interface challenging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility as measured by attrition

Feasibility as measured by study accrual

Feasibility as measured by the number of post-study sessions assessments completed

+3 more

Secondary outcome measures

Acceptability as measured by Atkinson's tool of mHealth innovations.

Acceptability as measured by the Client Satisfaction Questionnaire.

Change in Computer Self-Efficacy

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PainPacExperimental Treatment1 Intervention

4 behavioral cancer pain intervention sessions delivered by mobile application. Patient-focused intervention. PainPac uses Social Cognitive Theory to promote behaviors to improve pain, self-efficacy for pain management, and pain-related quality of life indices. It also uses real-time data to personalize the intervention and messaging to participants. The app also has interactive components to improve coping skills engagement.

Group II: PCST-VideoActive Control1 Intervention

4 behavioral cancer pain intervention sessions delivered by videoconferencing by a pain therapist in the medical center to the patient in their natural environment (e.g., home). Sessions will be scheduled weekly for 45-60 min and mimic in person sessions. PCST-Video session content is matches the PainPac skills modules. PCST-Video participants will complete assessments at the same intervals as PainPac participants.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,582 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,790 Total Patients Enrolled

Sarah A Kelleher, PhDPrincipal InvestigatorDuke University

2 Previous Clinical Trials

190 Total Patients Enrolled

Frequently Asked Questions

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

Does the current trial accept participants of advanced age?

"This research is looking for individuals whose age is between 18 and 110."

Answered by AI

Who is qualified to partake in this research project?

"In order to be admitted into this trial, potential participants must have been diagnosed with colorectal cancer and fall within the age range of 18-110. The study is set to accept approximately 60 patients."

Answered by AI

Are there any open slots available for individuals to join this investigation?

"This research initiative, which was initiated on September 28th 2023 and subsequently adjusted on October 26th 2023, is actively recruiting patients per the information provided by clinicaltrials.gov."

Answered by AI

What is the scope of participants for this clinical research?

"Affirmative. Based on the information hosted on clinicaltrials.gov this research trial is currently accepting applications for participation. The advertisement of this study was posted in September 28th 2023 and updated last October 26th 2023, with 60 patients being admitted at a single location."

Answered by AI

What are the primary objectives of this research project?

"This trial's primary outcome, assessed over the 15-month period, will be Feasibility as measured by attrition. Secondary measures of success involve Engagement in Study which is defined by weekly app logins and practicing coping skills at least 3 times a week; Change in PROMIS - Emotional Distress (Depression) Short Form which assesses emotional distress levels through 8 questions on a 5-point scale; and Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI), with pain severity being gauged using 4 questions rated from 0 to 10."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings (PainPac)

2023. "Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings (PainPac)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05686122.

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