Clinical trial NCT05686122: Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings (PainPac)
Official title: Initial Testing of a Mobile App Pain Coping Intervention for Outpatient Oncology Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer
pain
coping
mHealth
symptom management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-01-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as measured by study accrual
timeFrame: 15 months
measure: Feasibility as measured by attrition
timeFrame: 1-month post-baseline assessment
measure: Feasibility as measured by the number of study baseline assessments completed
timeFrame: 20 minutes
measure: Feasibility as measured by the number of post-study sessions assessments completed
timeFrame: 20 minutes
measure: Feasibility as measured by the number of study 1-month follow up assessments completed
timeFrame: 20 minutes
measure: Feasibility of PainPac
timeFrame: 11 Weeks
Secondary outcomes:
measure: Acceptability as measured by the Client Satisfaction Questionnaire.
timeFrame: 20 minutes
measure: Acceptability as measured by Atkinson's tool of mHealth innovations.
timeFrame: 20 minutes
measure: PainPac Patient Preferences, Barriers, Facilitators, Attitudes, and Beliefs
timeFrame: Post-Intervention Survey, 20 minutes
measure: Change in Computer Self-Efficacy
timeFrame: Post-Intervention Survey, 20 minutes
measure: Change in Pain Severity as Assessed With the Brief Pain Inventory (BPI)
timeFrame: 11 weeks
measure: Pain Interference as Assessed With the Brief Pain Inventory (BPI) - Pain Interference Scale
timeFrame: 11 weeks
measure: Change in Pain Self-Efficacy for Pain Management
timeFrame: 11 weeks
measure: Change in Patient Burden
timeFrame: 11 Weeks
measure: Engagement in Study
timeFrame: 11 Weeks
measure: Change in Quality of Life
timeFrame: 11 Weeks
measure: Change in PROMIS - Emotional Distress (Depression) Short Form
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Sarah A Kelleher, PhD
role: PRINCIPAL_INVESTIGATOR
References: