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

NCT05686122 | Completed Results

• 2 other identifiers: Pro001123971R21CA273832
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

cancer; pain; coping; mHealth; symptom management

Outcome Measures

Primary Outcomes (6)

• Feasibility as Measured by Study Accrual

  Reaching target accrual (N=60) within 15 months.

  Baseline

• Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit)

  1-month follow-up (9-12 weeks post-baseline)

• Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments

  Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the study baseline assessment.

  Baseline

• Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments

  Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the post-study sessions assessment.

  Post-treatment assessment (5-8 weeks post-baseline)

• Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed

  Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 1-month follow up assessment.

  1-month follow-up (9-12 weeks post-baseline)

• Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions

  Includes protocol adherence indicated by calculating the degree to which participants are willing/able to complete the 4 PainPac skills modules or 4 PCST-Video sessions.

  5-8 weeks post-baseline

Secondary Outcomes (12)

• Acceptability as Measured by the Client Satisfaction Questionnaire.

  Post-treatment assessment (5-8 weeks post-baseline)

• Acceptability as Measured by Atkinson's Tool of mHealth Innovations.

  Post-treatment assessment (5-8 weeks post-baseline)

• Computer Self-Efficacy

  Post-treatment assessment (5-8 weeks post-baseline)

• Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)

  Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)

• Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale

  Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)

Study Arms (2)

PainPac

EXPERIMENTAL

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.

Behavioral: PainPac

PCST-Video

NO 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.

Interventions

PainPac BEHAVIORAL

Patient-focused behavioral pain intervention delivered via mobile application.

PainPac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Pain

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sarah Kelleher, PhD
• Organization: Duke University School of Medicine

sarah.kelleher@duke.edu

919-416-3405

Study Officials

• Sarah A Kelleher, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: September 28, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)