N/A Completed N=60 Randomized Supportive Care

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

Colorectal Cancer

Source: ClinicalTrials.gov NCT05686122 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcomePrimary: Feasibility as Measured by Study Accrual — 62 participants

Summary

PainPac is innovative in its potential to integrate with healthcare systems through electronic medical records (EMRs). PainPac leverages technology to increase patient access to interventions and uses real-time assessment to improve care. PainPac is positioned to rapidly provide improved care through combining biological data (e.g., EMRs, patient collected) with behavioral data to dramatically improve outcomes. PainPac could track beneficial outcomes related to clinical pain scores (e.g., patients with scores 4-8 benefit) and intervention implementation could be based on this; a more advanced possibility is use of geospatial tracking to predict space/time where pain is likely to impact functioning and push an intervention strategy - behavioral or pharmacological. PainPac is designed for future transmission of data to EMRs to inform providers of patient status. This work will provide data to bypass traditional efficacy trials and move quickly to a large effectiveness trial.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility as Measured by Study Accrual	62	—
PRIMARY Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit)	2; 1	—
PRIMARY Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments	60	—
PRIMARY Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments	28; 27	—
PRIMARY Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed	28; 29	—
PRIMARY Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions	27; 24	—
SECONDARY Acceptability as Measured by the Client Satisfaction Questionnaire.	28.11; 28.93	—
SECONDARY Acceptability as Measured by Atkinson's Tool of mHealth Innovations.	4.82	—
SECONDARY Computer Self-Efficacy	83.71	—
SECONDARY Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)	3.73; 4.55; 3.88; 3.96; 3.51; 3.37	—
SECONDARY Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale	3.34; 4.08; 3.05; 3.21; 2.78; 2.77	—
SECONDARY Change in Pain Self-Efficacy for Pain Management	53.72; 59.70; 63.79; 67.92; 67.00; 65.52	—
SECONDARY Burden as Measured by # of Sessions Completed	3.77; 3.37	—
SECONDARY Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)	1.32; 12.25	—
SECONDARY Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)	23.57; 27.63	—
SECONDARY Engagement in Study	9.22; 5.21; 5.52	—
SECONDARY Change in Quality of Life	6.66; 9.60; 7.39; 8.63; 9.50; 14.93	—
SECONDARY Change in PROMIS - Emotional Distress (Depression) Short Form	51.19; 50.16; 50.52; 47.43; 49.20; 48.24	—

Eligibility Criteria

Inclusion Criteria

Stage I-IV Colorectal Cancer diagnosis
18 years of age or older

Exclusion Criteria

Cognitive Impairment
Brain Metastases
Severe psychiatric condition (e.g., psychosis) that would contraindicate safe participation
Participation in behavioral pain management in the past 6 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05686122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.