Clinical trial NCT05917171: Pilot Trial of an Online Pain Coping Skills Training Program in Spanish
Official title: Developing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Patients With Cancer Pain Using a Community Engaged Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Keywords: pain coping skills
cancer-related pain
pain management
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pilot study to assess feasibility and acceptability.
Primary purpose: OTHER

Brief summary: The goal of this pilot study is to assess the feasibility and acceptability of an 8-week online pain coping skills training program designed specifically for Spanish-speaking Hispanic and Latine populations experiencing cancer-related pain. The main questions aim to answer are: 1. what is the feasibility of this program for engaging and recruiting Spanish speaking members of the Hispanic and Latine community?; 2. How well is the program accepted by Spanish speaking members of the Hispanic and Latine community?. Participants will answer questions about their cancer related pain before and after they participate in an 8-week pain coping skills training program offered online.

Detailed description: Cancer-related pain is a significant adverse effect of cancer and cancer treatment, which poses significant management challenges for patients. Compared to non-Hispanic whites, Spanish-speaking Hispanic patients routinely experience disparities in cancer-related care that negatively impact quality of life, including more significant barriers in accessing quality care, less adequate pain management, and later-stage cancer diagnosis and treatment initiation. Limited English proficiency is a particularly difficult barrier among primarily Spanish-speaking Hispanic patients, as communication challenges with providers contributes to poorer pain outcomes and suboptimal pain management. To support Spanish-speaking populations and strive towards more equitable care (e.g., accessible, convenient, and cost-effective), this study is leveraging its prior work in Pain Coping Skills Training (PCST) through the cultural and linguistic translation of an online PCST program, painTRAINER. This evidence-based program, delivered online over eight weeks, facilitates development of pain coping skills to improve pain outcomes while also reducing reliance on opioids for pain management.

This pilot study follows a community-engaged and community-driven approach for translating and adapting the painTRAINER program into a linguistically and culturally appropriate version optimized for diverse Spanish-speaking adults experiencing cancer-related pain.

The study team integrated Spanish-speaking staff, community members, community-based organizations, and key stakeholders as members of the research team to guide the program adaptation process. Community partners include key members of the Hispanic community and leaders from various community organizations, who have participated on the study's Community Advisory Board (CAB) and on a Community-based Programmatic Review Panel (PRP). Both groups include members from diverse Spanish speaking countries with diversity in age, gender, and educational background and have been integral in guiding the translation and adaptation process. This group continue to play a key role in future phases of the project such as participant recruitment, implementation, data analysis and interpretation, and dissemination of findings.

Prior studies show that PCST is effective, engaging, and acceptable to English-speaking patients, and also is an accessible, convenient, and cost-effective pain management tool when delivered online. PainTRAINER's effectiveness for pain management is well established via NIH-funded trials. Results from previous studies show critical implications in the development and delivery of pain management for underserved cancer populations to foster equity in care and reduce reliance on opioid medications. The community-engaged and culturally-informed process to fully adapt and translate the painTRAINER program will yield an effective Spanish-language PCST program that fills a gap in cancer-pain management by further expanding access to quality care among Hispanic patients. Community partnerships are key to the successful adaptation and future intervention efforts of the Spanish-language version of painTRAINER. The availability of effective and culturally-appropriate pain management options for Spanish-speaking patients will provide communities with tools and resources necessary not only for managing pain and enhancing quality of life, but for empowering Spanish-speaking patients to be strong advocates for their health.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of invasive cancer treated with either single modality therapy or any combination of therapies.
* Is ≤ 5 years since completion of definitive cancer therapy.
* May be off treatment, receiving adjuvant or maintenance therapy or have cancer that is stable/controlled.
* Pain score ≥ 4 (PROMIS Pain Intensity (1a) scale) on "Most Days" or more (Graded Chronic Pain Scale).
* Pain of new onset or significantly exacerbated since cancer diagnosis or initiation of cancer treatment.
* If taking analgesics, the analgesic regimen must be stable; unexpected dose adjustments are allowed.
* Expected capable of completing study activities (clinician judgment) with ECOG performance status ≤ 2.
* Age ≥18 years at the time of study entry.
* Identify as Hispanic or Latine AND able to read and speak Spanish.

Exclusion Criteria:

* Has a disability that precludes completion of study activities.
* Reports only preexisting pain conditions unrelated to cancer or cancer treatment.
* Has a known or suspected diagnosable substance use disorder or opioid overuse disorder.

Primary outcomes:
measure: Adherence - percent of participants who complete the study modules as a measure of retention
timeFrame: baseline
measure: Adherence - percent of participants who complete the study modules as a measure of retention
timeFrame: Week 10
measure: Adherence - percent of participants who complete the study modules as a measure of retention
timeFrame: Week 18
measure: Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
timeFrame: Baseline
measure: Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
timeFrame: Week 10
measure: Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate
timeFrame: Week 18
Secondary outcomes:
measure: Change in Pain interference scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Pain severity scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Fatigue scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Sleep disturbance scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Pain resilience scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Cognitive Function scores
timeFrame: baseline, 10 weeks, 18 weeks
measure: Change in Physical Function scores
timeFrame: baseline, 10 weeks, 18 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Donald B Penzien, PhD
role: PRINCIPAL_INVESTIGATOR
References: