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Behavioral Intervention

Mobile App Intervention for Pain Management in Colorectal Cancer Patients

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

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

Primary study objectives

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 study objectives

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

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PainPac

2023

N/A

~70

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