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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686122
• Other study ID #: Pro00112397
• Secondary ID: 1R21CA273832
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: Sarah A Kelleher, PhD
• Phone: 919-416-3405
• Email: sarah.kelleher[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PainPac is innovative in its potential to integrate with healthcare systems through electronic medical records (EMRs). PainPac leverages technology to increase patient access to interventions and uses real-time assessment to improve care. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• PainPac
Patient-focused behavioral pain intervention delivered via mobile application.

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by study accrual	Reaching target accrual (N=60) within 15 months.	15 months
Primary	Feasibility as measured by attrition	<25% attrition by 1-month post-baseline.	1-month post-baseline assessment
Primary	Feasibility as measured by the number of study baseline assessments completed	Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the study baseline assessment.	20 minutes
Primary	Feasibility as measured by the number of post-study sessions assessments completed	Protocol adherence indicated by calculating the degree to which participants are willing/able to complete the post-study sessions assessment.	20 minutes
Primary	Feasibility as measured by the number of 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.	20 minutes
Primary	Feasibility of PainPac	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.	11 Weeks
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.	20 minutes
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 agree, 2=agree, 3=somewhat agree, 4=somewhat disagree. 5=disagree, and 6=strongly disagree.	20 minutes
Secondary	PainPac Patient Preferences, Barriers, Facilitators, Attitudes, and Beliefs	Post-intervention, measured together as one measure, patients will be asked 10 items modeled from labs previous work. Items will be answered on a 0-10 scale with 0=low preference, barrier, belief and 10=high preference, barrier, belief.	Post-Intervention Survey, 20 minutes
Secondary	Change in Computer Self-Efficacy	Post-Intervention, 10 items on a 10 point scale from 0=not at all confident to 10=completely confident. Patients are asked 10 items regarding their confidence in ability to use technology (computer and smartphone app).	Post-Intervention Survey, 20 minutes
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.	11 weeks
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.	11 weeks
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. The 10-item Computer Self-Efficacy Scale will be used to ask about patients' confidence in using technology to receive a behavioral pain intervention.	11 weeks
Secondary	Change in Patient Burden	12-item measure developed in the lab through a NCI study examining burdens with accessing care after a cancer diagnosis. Patients will rate difficulty completing the intervention (PainPac modules or PCST-Video sessions) on a 1=not at all to 5=very much scale based on physical, emotional, financial burdens. A summated scale will be used to assess internal validity using Cronbach's alpha of 0.75.	11 Weeks
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.	11 Weeks
Secondary	Change in Quality of Life	Centers for Disease Control Health Related Quality of Life 14-item measure. This measure assesses healthy days in the last month and activity limitations and symptoms.	11 Weeks
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.	11 weeks