Trial Outcomes & Findings for Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings (PainPac) (NCT NCT05686122)

NCT ID: NCT05686122

Last Updated: 2025-09-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-09-04

Participant Flow

Two additional participants were consented but were not randomized and did not complete the baseline assessments.

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PainPac n=30 Participants 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.	PCST-Video n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	58.10 years STANDARD_DEVIATION 12.41 • n=5 Participants	58.20 years STANDARD_DEVIATION 10.46 • n=7 Participants	58.15 years STANDARD_DEVIATION 11.38 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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

Outcome measures

Measure	Total Consented Participants n=82 Participants 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.	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.
Feasibility as Measured by Study Accrual	62 participants	—

PRIMARY outcome

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

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit)	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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

Outcome measures

Measure	Total Consented Participants n=62 Participants 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.	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.
Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments	60 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments	28 Participants	27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed	28 Participants	29 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions	27 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Acceptability as Measured by the Client Satisfaction Questionnaire.	28.11 units on a scale Standard Deviation 3.74	28.93 units on a scale Standard Deviation 3.57

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	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.
Acceptability as Measured by Atkinson's Tool of mHealth Innovations.	4.82 units on a scale Standard Deviation .52	—

SECONDARY outcome

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

Population: Computer Self-Efficacy was a PainPac-specific measure of self-efficacy, and thus only PainPac participants completed this measure.

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.

Outcome measures

Measure	Total Consented Participants n=28 Participants 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.	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.
Computer Self-Efficacy	83.71 score on a scale Standard Deviation 19.82	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) Baseline (A1)	3.73 score on a scale Standard Deviation 1.91	4.55 score on a scale Standard Deviation 2.32
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) Post-Assessment (A2)	3.88 score on a scale Standard Deviation 1.88	3.96 score on a scale Standard Deviation 2.19
Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) 1 month follow-up (A3)	3.51 score on a scale Standard Deviation 2.49	3.37 score on a scale Standard Deviation 2.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale Post-Assessment (A2)	3.05 score on a scale Standard Deviation 1.69	3.21 score on a scale Standard Deviation 2.19
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale Baseline (A1)	3.34 score on a scale Standard Deviation 2.07	4.08 score on a scale Standard Deviation 2.55
Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale 1-month follow-up (A3)	2.78 score on a scale Standard Deviation 2.12	2.77 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Change in Pain Self-Efficacy for Pain Management Baseline (A1)	53.72 score on a scale Standard Deviation 23.69	59.70 score on a scale Standard Deviation 23.08
Change in Pain Self-Efficacy for Pain Management Post-Assessment (A2)	63.79 score on a scale Standard Deviation 16.72	67.92 score on a scale Standard Deviation 21.32
Change in Pain Self-Efficacy for Pain Management 1-month follow-up (A3)	67.00 score on a scale Standard Deviation 20.40	65.52 score on a scale Standard Deviation 22.61

SECONDARY outcome

Timeframe: 3-8 weeks post-baseline

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Burden as Measured by # of Sessions Completed	3.77 sessions Standard Deviation .82	3.37 sessions Standard Deviation 1.33

SECONDARY outcome

Timeframe: 0-2 weeks post-baseline

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention)	1.32 days Standard Deviation 2.28	12.25 days Standard Deviation 10.92

SECONDARY outcome

Timeframe: 3-8 weeks from Session 1

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)	23.57 days Standard Deviation 5.31	27.63 days Standard Deviation 6.70

SECONDARY outcome

Timeframe: 5-8 weeks post-baseline

Population: Patients in the PCST-Video arm did not log into a mobile app so were not analyzed for the number of weekly log ins.

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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Engagement in Study Weekly Log-Ins	9.22 Times per week Standard Deviation 4.20	—
Engagement in Study Weekly Skills Practice	5.21 Times per week Standard Deviation 1.91	5.52 Times per week Standard Deviation 1.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Change in Quality of Life Baseline (A1)	6.66 healthy days in the past month Standard Deviation 7.18	9.60 healthy days in the past month Standard Deviation 9.50
Change in Quality of Life Post-assessment (A2)	7.39 healthy days in the past month Standard Deviation 7.49	8.63 healthy days in the past month Standard Deviation 8.85
Change in Quality of Life 1-month follow-up (A3)	9.50 healthy days in the past month Standard Deviation 9.28	14.93 healthy days in the past month Standard Deviation 15.27

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Consented Participants n=30 Participants 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.	PCST-Video n=30 Participants 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.
Change in PROMIS - Emotional Distress (Depression) Short Form Baseline (A1)	51.19 score on a scale Standard Deviation 7.13	50.16 score on a scale Standard Deviation 8.65
Change in PROMIS - Emotional Distress (Depression) Short Form Post-Assessment (A2)	50.52 score on a scale Standard Deviation 7.11	47.43 score on a scale Standard Deviation 8.98
Change in PROMIS - Emotional Distress (Depression) Short Form 1-month follow-up (A3)	49.20 score on a scale Standard Deviation 8.34	48.24 score on a scale Standard Deviation 10.23

Adverse Events

PainPac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCST-Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Kelleher, PhD

Duke University School of Medicine

Phone: 919-416-3405

Email: sarah.kelleher@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place