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Colorectal CancerNCT05686122

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

A study testing PainPac in people with Colorectal Cancer, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
PainPac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
28 Sep 2023to 30 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
PainPac
Keywords
cancer, pain, coping, mHealth, symptom management
Medical subject headings
Colorectal Neoplasms, Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainPacBehavioural

    Patient-focused behavioral pain intervention delivered via mobile application.

Study groups in NCT05686122
Study groupRoleWhat they receive
PainPacExperimental4 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.
Receives: Behavioral: PainPac
PCST-VideoNo intervention4 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility as Measured by Study Accrual

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

    Measured: Baseline

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

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

  3. 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.

    Measured: Baseline

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: 5-8 weeks post-baseline

Secondary outcomes (12)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. Burden as Measured by # of Sessions Completed

    Measured: 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)

    Measured: 0-2 weeks post-baseline

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

    Measured: 3-8 weeks from Session 1

  10. 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.

    Measured: 5-8 weeks post-baseline

  11. Change in Quality of Life

    This measure assesses healthy days in the last month.

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

  12. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start28 Sep 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05686122
Sponsor's protocol ID
Pro00112397
Other IDs
1R21CA273832
Status last verified
Jul 2025
First submitted
6 Jan 2023
Last updated
4 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelleher SA, Fisher HM, Chou N, Diachina AK, Winger JG, Uronis HE, Keefe FJ, Somers TJ. Initial testing of a mobile app behavioral pain coping intervention for patients with cancer: Results of a pilot randomized controlled trial. J Psychosoc Oncol. 2026 Apr 8:1-28. doi: 10.1080/07347332.2026.2652946. Online ahead of print.

    PubMed 41950509

Questions about this trial

What is this clinical trial studying?

A study testing PainPac in people with Colorectal Cancer, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility as Measured by Study Accrual (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686122, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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Clinical Trial NCT05686122 | AzTrials