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Completed

NCT Number: NCT05686122

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PainPac

Behavioral

Patient-focused behavioral pain intervention delivered via mobile application.

Primary outcomes

  1. Feasibility as Measured by Study Accrual

    Time frame: Baseline

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

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

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

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

    Time frame: Baseline

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

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

    Time frame: Post-treatment assessment (5-8 weeks post-baseline)

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

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

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

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

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

    Time frame: 5-8 weeks post-baseline

    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.

Secondary outcomes

  1. Acceptability as Measured by the Client Satisfaction Questionnaire.

    Time frame: Post-treatment assessment (5-8 weeks post-baseline)

    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.

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

    Time frame: Post-treatment assessment (5-8 weeks post-baseline)

    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.

  3. Computer Self-Efficacy

    Time frame: Post-treatment assessment (5-8 weeks post-baseline)

    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.

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

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

    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.

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

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

    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.

  6. Change in Pain Self-Efficacy for Pain Management

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

    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.

  7. Burden as Measured by # of Sessions Completed

    Time frame: 3-8 weeks post-baseline

  8. Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)

    Time frame: 0-2 weeks post-baseline

  9. Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)

    Time frame: 3-8 weeks from Session 1

  10. Engagement in Study

    Time frame: 5-8 weeks post-baseline

    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.

  11. Change in Quality of Life

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

    This measure assesses healthy days in the last month.

  12. Change in PROMIS - Emotional Distress (Depression) Short Form

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

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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