NCT05686122

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

Completed NA Results posted Last updated 4 September 2025

What this trial tests

NA trial testing PainPac in Colorectal Cancer in 62 participants. Completed in 30 October 2024.

Timeline

28 September 2023

Primary endpoint
30 October 2024

30 October 2024

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	62
Start date	28 September 2023
Primary completion	30 October 2024
Estimated completion	30 October 2024
Sites	1 location across United States

Drugs / interventions tested

• PainPac

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Duke University

Who can join

18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility as Measured by Study Accrual Primary · Baseline

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

Group	Value	95% CI
Total Consented Participants	62

Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit) Primary · 1-month follow-up (9-12 weeks post-baseline)

Group	Value	95% CI
PainPac	2
PCST-Video	1

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

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

Group	Value	95% CI
Total Consented Participants	60

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

Group	Value	95% CI
PainPac	28
PCST-Video	27

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

Group	Value	95% CI
PainPac	28
PCST-Video	29

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

Group	Value	95% CI
PainPac	27
PCST-Video	24

Acceptability as Measured by the Client Satisfaction Questionnaire. Secondary · 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.

Group	Value	95% CI
PainPac	28.11	± 3.74
PCST-Video	28.93	± 3.57

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

Group	Value	95% CI
PainPac	4.82	± .52

Computer Self-Efficacy Secondary · 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.

Group	Value	95% CI
PainPac	83.71	± 19.82

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

Baseline (A1)

Group	Value	95% CI
PainPac	3.73	± 1.91
PCST-Video	4.55	± 2.32

Post-Assessment (A2)

Group	Value	95% CI
PainPac	3.88	± 1.88
PCST-Video	3.96	± 2.19

1 month follow-up (A3)

Group	Value	95% CI
PainPac	3.51	± 2.49
PCST-Video	3.37	± 2.10

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

Baseline (A1)

Group	Value	95% CI
PainPac	3.34	± 2.07
PCST-Video	4.08	± 2.55

Post-Assessment (A2)

Group	Value	95% CI
PainPac	3.05	± 1.69
PCST-Video	3.21	± 2.19

1-month follow-up (A3)

Group	Value	95% CI
PainPac	2.78	± 2.12
PCST-Video	2.77	± 2.07

Change in Pain Self-Efficacy for Pain Management Secondary · 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.

Baseline (A1)

Group	Value	95% CI
PainPac	53.72	± 23.69
PCST-Video	59.70	± 23.08

Post-Assessment (A2)

Group	Value	95% CI
PainPac	63.79	± 16.72
PCST-Video	67.92	± 21.32

1-month follow-up (A3)

Group	Value	95% CI
PainPac	67.00	± 20.40
PCST-Video	65.52	± 22.61

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Initial testing of a mobile app behavioral pain coping intervention for patients with cancer: Results of a pilot randomized controlled trial.
   Kelleher SA, Fisher HM, Chou N, Diachina AK, et al · · 2026 · cited 1× · PMID 41950509 · DOI 10.1080/07347332.2026.2652946