Colorectal Cancer
Conditions
Keywords
cancer, pain, coping, mHealth, symptom management
Brief 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. 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.
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.
Interventions
BEHAVIORALPainPac
Patient-focused behavioral pain intervention delivered via mobile application.
Sponsors
National Institutes of Health (NIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Study Accrual | Baseline | Reaching target accrual (N=60) within 15 months. |
| 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 | Baseline | Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the study baseline assessment. |
| Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments | 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. |
| Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed | 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. |
| Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Acceptability as Measured by the Client Satisfaction Questionnaire. | 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. |
| Change in Quality of Life | 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. |
| Change in PROMIS - Emotional Distress (Depression) Short Form | 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. |
| Engagement in Study | 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. |
| Acceptability as Measured by Atkinson's Tool of mHealth Innovations. | 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. |
| Computer Self-Efficacy | 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. |
| Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | 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. |
| Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | 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. |
| Change in Pain Self-Efficacy for Pain Management | 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. |
Countries
United States
Participant flow
Pre-assignment details
Two additional participants were consented but were not randomized and did not complete the baseline assessments.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | PainPac | PCST-Video | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Continuous | 58.10 years STANDARD_DEVIATION 12.41 | 58.20 years STANDARD_DEVIATION 10.46 | 58.15 years STANDARD_DEVIATION 11.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 28 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 18 Participants | 41 Participants |
| Sex: Female, Male Female | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Consented Participants | Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit) | 2 Participants |
| PCST-Video | Feasibility as Measured by Attrition (Number of Participants Who Did Not Complete the 1-month Visit) | 1 Participants |
Primary
Feasibility as Measured by Study Accrual
Reaching target accrual (N=60) within 15 months.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Consented Participants | Feasibility as Measured by Study Accrual | 62 participants |
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.
Time frame: Post-treatment assessment (5-8 weeks post-baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Consented Participants | Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments | 28 Participants |
| PCST-Video | Feasibility as Measured by the Number of Participants Who Completed Post-study Sessions Assessments | 27 Participants |
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.
Time frame: 1-month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Consented Participants | Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed | 28 Participants |
| PCST-Video | Feasibility as Measured by the Number of Participants Who Completed Study 1-month Follow up Assessments Completed | 29 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Consented Participants | Feasibility as Measured by the Number of Participants Who Completed Study Baseline Assessments | 60 Participants |
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.
Time frame: 5-8 weeks post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Consented Participants | Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions | 27 Participants |
| PCST-Video | Feasibility of PainPac, as Measured by the Total # of Participants Who Completed All Four Sessions | 24 Participants |
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.
Time frame: Post-treatment assessment (5-8 weeks post-baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented Participants | Acceptability as Measured by Atkinson's Tool of mHealth Innovations. | 4.82 units on a scale | Standard Deviation 0.52 |
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.
Time frame: Post-treatment assessment (5-8 weeks post-baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented Participants | Acceptability as Measured by the Client Satisfaction Questionnaire. | 28.11 units on a scale | Standard Deviation 3.74 |
| PCST-Video | Acceptability as Measured by the Client Satisfaction Questionnaire. | 28.93 units on a scale | Standard Deviation 3.57 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented 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 |
| PCST-Video | Burden as Measured by # of Days From the Baseline Assessment to Completion of Session 1 (Days to Start Intervention) | 12.25 days | Standard Deviation 10.92 |
Secondary
Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention)
Time frame: 3-8 weeks from Session 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented Participants | Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention) | 23.57 days | Standard Deviation 5.31 |
| PCST-Video | Burden as Measured by # of Days to Complete All Modules/Sessions (Days to Complete Intervention) | 27.63 days | Standard Deviation 6.7 |
Secondary
Burden as Measured by # of Sessions Completed
Time frame: 3-8 weeks post-baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented Participants | Burden as Measured by # of Sessions Completed | 3.77 sessions | Standard Deviation 0.82 |
| PCST-Video | Burden as Measured by # of Sessions Completed | 3.37 sessions | Standard Deviation 1.33 |
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.
Time frame: Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented Participants | Change in Pain Self-Efficacy for Pain Management | Baseline (A1) | 53.72 score on a scale | Standard Deviation 23.69 |
| Total Consented Participants | Change in Pain Self-Efficacy for Pain Management | Post-Assessment (A2) | 63.79 score on a scale | Standard Deviation 16.72 |
| Total Consented Participants | Change in Pain Self-Efficacy for Pain Management | 1-month follow-up (A3) | 67.00 score on a scale | Standard Deviation 20.4 |
| PCST-Video | Change in Pain Self-Efficacy for Pain Management | Baseline (A1) | 59.70 score on a scale | Standard Deviation 23.08 |
| PCST-Video | Change in Pain Self-Efficacy for Pain Management | Post-Assessment (A2) | 67.92 score on a scale | Standard Deviation 21.32 |
| PCST-Video | Change in Pain Self-Efficacy for Pain Management | 1-month follow-up (A3) | 65.52 score on a scale | Standard Deviation 22.61 |
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.
Time frame: Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented 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 |
| Total Consented Participants | 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 |
| Total Consented Participants | 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 |
| PCST-Video | Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | Baseline (A1) | 4.55 score on a scale | Standard Deviation 2.32 |
| PCST-Video | Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | Post-Assessment (A2) | 3.96 score on a scale | Standard Deviation 2.19 |
| PCST-Video | Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI) | 1 month follow-up (A3) | 3.37 score on a scale | Standard Deviation 2.1 |
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.
Time frame: Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented Participants | Change in PROMIS - Emotional Distress (Depression) Short Form | Baseline (A1) | 51.19 score on a scale | Standard Deviation 7.13 |
| Total Consented Participants | Change in PROMIS - Emotional Distress (Depression) Short Form | Post-Assessment (A2) | 50.52 score on a scale | Standard Deviation 7.11 |
| Total Consented Participants | Change in PROMIS - Emotional Distress (Depression) Short Form | 1-month follow-up (A3) | 49.20 score on a scale | Standard Deviation 8.34 |
| PCST-Video | Change in PROMIS - Emotional Distress (Depression) Short Form | Baseline (A1) | 50.16 score on a scale | Standard Deviation 8.65 |
| PCST-Video | Change in PROMIS - Emotional Distress (Depression) Short Form | Post-Assessment (A2) | 47.43 score on a scale | Standard Deviation 8.98 |
| PCST-Video | Change in PROMIS - Emotional Distress (Depression) Short Form | 1-month follow-up (A3) | 48.24 score on a scale | Standard Deviation 10.23 |
Secondary
Change in Quality of Life
This measure assesses healthy days in the last month.
Time frame: Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented Participants | Change in Quality of Life | Post-assessment (A2) | 7.39 healthy days in the past month | Standard Deviation 7.49 |
| Total Consented Participants | Change in Quality of Life | Baseline (A1) | 6.66 healthy days in the past month | Standard Deviation 7.18 |
| Total Consented Participants | Change in Quality of Life | 1-month follow-up (A3) | 9.50 healthy days in the past month | Standard Deviation 9.28 |
| PCST-Video | Change in Quality of Life | Baseline (A1) | 9.60 healthy days in the past month | Standard Deviation 9.5 |
| PCST-Video | Change in Quality of Life | Post-assessment (A2) | 8.63 healthy days in the past month | Standard Deviation 8.85 |
| PCST-Video | Change in Quality of Life | 1-month follow-up (A3) | 14.93 healthy days in the past month | Standard Deviation 15.27 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Consented Participants | Computer Self-Efficacy | 83.71 score on a scale | Standard Deviation 19.82 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented Participants | Engagement in Study | Weekly Log-Ins | 9.22 Times per week | Standard Deviation 4.2 |
| Total Consented Participants | Engagement in Study | Weekly Skills Practice | 5.21 Times per week | Standard Deviation 1.91 |
| PCST-Video | Engagement in Study | Weekly Skills Practice | 5.52 Times per week | Standard Deviation 1.63 |
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.
Time frame: Baseline, Post-Assessment (5-8 weeks post-baseline), 1 month follow-up (9-12 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Consented Participants | 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 |
| Total Consented 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 |
| Total Consented Participants | 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 |
| PCST-Video | Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | Baseline (A1) | 4.08 score on a scale | Standard Deviation 2.55 |
| PCST-Video | Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | Post-Assessment (A2) | 3.21 score on a scale | Standard Deviation 2.19 |
| PCST-Video | Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale | 1-month follow-up (A3) | 2.77 score on a scale | Standard Deviation 2.07 |