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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: PainPac

Detailed Description

The investigators will use a pilot RCT to examine PainPac feasibility, patient burden, engagement, acceptability, and initial pain-related outcomes, compared to a therapist led videoconference delivered behavioral pain intervention (PCST-Video) in colorectal cancer patients with pain. Investigators will use quantitative and qualitative data to optimize PainPac. Participants will complete assessments at pre-treatment (A1), post-treatment (A2; 4 weeks post-A1), and 1 month follow-up (A3; 1 month post-A2) (months 5-22). The pain management strategies are relevant and efficacious across cancer types. Due to the pilot nature of this work, investigators will enroll an opportunity sample of colorectal cancer patients.

PainPac is a patient-focused intervention developed using cognitive-behavioral theory and empirically supported strategies to enhance patients' ability to manage their pain. PainPac is a mobile app available to participants on a smartphone or tablet. 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. PainPac contains 4 modules, each including a skill that has shown efficacy for reducing pain in patients with cancer. Patients are prompted to complete one module each week for 4 weeks. The app also has interactive components to improve coping skills engagement.

Participants randomized to PCST-Video will receive 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 described above. PCST-Video participants will complete assessments at the same intervals as PainPac participants.

Aim 1: Test whether PainPac is feasible (primary aim), low burden, engaging, and acceptable.

Aim 2: Examine the impact of PainPac on pain severity, pain interference, pain self-efficacy, and quality of life.

Aim 3: Gather quantitative and qualitative post-treatment data on patients' preferences, barriers, and facilitators regarding PainPac to update and optimize PainPac for a future large randomized clinical effectiveness trial.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PainPac; 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; Patient-focused behavioral pain intervention delivered via mobile application.
No Intervention: PCST-Video; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability as Measured by the Client Satisfaction Questionnaire.	10-item Client Satisfaction Questionnaire (CSQ). This questionnaire contains 10 items rated from 1=low acceptability to 4=high acceptability; scores are created by utilizing the Likert Scale to average Client Satisfaction Questionnaire answers resulting in a score range from 1-4. The participant will complete this acceptability questionnaire as part of the post-session follow up assessment. A higher score indicates a higher satisfaction, with 32 indicating 100% satisfaction and 8 indicating 0% satisfaction.	Post-treatment assessment (5-8 weeks post-baseline)
Acceptability as Measured by Atkinson's Tool of mHealth Innovations.	Atkinson's tool will also be used to assess perceived attributes of mHealth innovations. Tool has 30 items about mHealth, participant indicates their level of agreement or disagreement on a 6-point Likert scale: l=strongly disagree, 2=disagree, 3=somewhat disagree, 4=somewhat agree. 5=agree, and 6=strongly agree. Scores range from 1-6 with higher scores indicating a more positive assessment of PainPac.	Post-treatment assessment (5-8 weeks post-baseline)
Computer Self-Efficacy	Post-Intervention, 10 items on a 10 point scale from 0=not at all confident to 10=completely confident. Total score ranges from 0-100. Patients are asked 10 items regarding their confidence in ability to use technology (computer and smartphone app). Higher scores indicate greater computer self-efficacy.	Post-treatment assessment (5-8 weeks post-baseline)
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)	Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their "worst", "least", "average", and "now" pain from 0=no pain to 10=worst pain imaginable. An average of the responses to these items is used to create a single pain severity score.	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	Pain interference will be assessed with the Brief Pain Inventory (BPI) - Pain Interference Scale. Patients will rate how much pain interfered with a variety of activities and mood states over the last 7 days from 0=does not interfere to 10=completely interferes. An average of the responses to these items is used to create a single pain severity score ranging from 0-10.	Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
Change in Pain Self-Efficacy for Pain Management	5-item self-efficacy subscale of the Chronic Pain Self-Efficacy Scale. Items ask about patients' certainty about pain control, pain during activities, and reducing pain without extra medication using a 10=very uncertain to 100=very certain scale and averaged. Total score ranges from 10-100. Higher scores correspond to higher self-efficacy for pain management.	Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
Burden as Measured by # of Sessions Completed		3-8 weeks post-baseline
Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)		0-2 weeks post-baseline
Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)		3-8 weeks from Session 1
Engagement in Study	Engagement is defined as the number of times/week participants log into PainPac and practice the skills. Engagement will be assessed based on app data and patient self-report. Patient Engagement will be assessed by electronic app data (e.g., PainPac weekly log-ins) and patient self-report defined as the number of times per week they practice the coping skills. >3 times/week will serve as the benchmark; if participants log into PainPac and/or practice the coping skills <3 times/week, PainPac will not be considered engaging.	5-8 weeks post-baseline
Change in Quality of Life	This measure assesses healthy days in the last month.	Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
Change in PROMIS - Emotional Distress (Depression) Short Form	Post-intervention and 1-month follow up, 8 items on a 5 point scale from 1=never, 2=rarely, 3=sometimes, 4=often, 5=always. Patients are asked 8-items regarding "in the past 7 days I felt..." to assess their emotional distress levels. The total score ranges from 37.1-81.1, with higher scores indicate higher distress.	Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sarah A Kelleher, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pain; cancer; coping; mHealth; symptom management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: Pro00112397; 1R21CA273832 (U.S. NIH Grant/Contract: National Institutes of Health (NIH))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No