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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA273832 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PainPac | Behavioral | Patient-focused behavioral pain intervention delivered via mobile application. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A Kelleher, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41950509 | Derived | 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. |
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Two additional participants were consented but were not randomized and did not complete the baseline assessments.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. PainPac is a patient-focused behavioral pain intervention delivered via mobile application. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. PainPac: Patient-focused behavioral pain intervention delivered via mobile application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility as Measured by Study Accrual | Reaching target accrual (N=60) within 15 months. | Out of 82 patients who screened eligible for this study, 62 patients consented to participate. 60 of those patients completed the baseline assessment and were randomized. | Posted | Number | participants | Baseline |
|
|
Approximately 11 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. PainPac: Patient-focused behavioral pain intervention delivered via mobile application. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Kelleher, PhD | Duke University School of Medicine | 919-416-3405 | sarah.kelleher@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2024 | Jun 25, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2024 | May 23, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit) | Posted | Count of Participants | Participants | 1-month follow-up (9-12 weeks post-baseline) |
|
|
|
| Primary | 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. | The number analyzed for this outcome includes the two participants who consented but did not complete the baseline assessments and were not randomized. Since the baseline assessment occurs before randomization, the study groups are combined for this measure. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Post-treatment assessment (5-8 weeks post-baseline) |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 1-month follow-up (9-12 weeks post-baseline) |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 5-8 weeks post-baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment assessment (5-8 weeks post-baseline) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Post-treatment assessment (5-8 weeks post-baseline) |
|
|
|
| Secondary | 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. | Computer Self-Efficacy was a PainPac-specific measure of self-efficacy, and thus only PainPac participants completed this measure. | Posted | Mean | Standard Deviation | score on a scale | Post-treatment assessment (5-8 weeks post-baseline) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline) |
|
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| Secondary | Burden as Measured by # of Sessions Completed | Posted | Mean | Standard Deviation | sessions | 3-8 weeks post-baseline |
|
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| Secondary | Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention) | Posted | Mean | Standard Deviation | days | 0-2 weeks post-baseline |
|
|
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| Secondary | Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention) | Posted | Mean | Standard Deviation | days | 3-8 weeks from Session 1 |
|
|
|
| Secondary | 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. | Patients in the PCST-Video arm did not log into a mobile app so were not analyzed for the number of weekly log ins. | Posted | Mean | Standard Deviation | Times per week | 5-8 weeks post-baseline |
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|
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| Secondary | Change in Quality of Life | This measure assesses healthy days in the last month. | Posted | Mean | Standard Deviation | healthy days in the past month | Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline) |
|
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 1 month follow-up (A3) |
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| 1-month follow-up (A3) |
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| 1-month follow-up (A3) |
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| Weekly Skills Practice |
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| 1-month follow-up (A3) |
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| 1-month follow-up (A3) |
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