Pilot Trial of an Online Pain Coping Skills Training Program in Spanish

NCT05917171 | Completed

• 1 other identifier: IRB00096781
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Keywords

pain coping skills; cancer-related pain; pain management

Outcome Measures

Primary Outcomes (6)

• Adherence - percent of participants who complete the study modules as a measure of retention

  To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).

  baseline

• Adherence - percent of participants who complete the study modules as a measure of retention

  To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).

  Week 10

• Adherence - percent of participants who complete the study modules as a measure of retention

  To evaluate the feasibility of implementing painTRAINER among Spanish speaking participants, the study will assess participants' adherence to painTRAINER and the capacity to retain them in a clinical trial. The pilot trial can be implemented completely remotely among community dwelling Spanish-speaking Hispanic/Latine individuals with cancer-related pain. The study will calculate the percent of participants who complete the study modules as a measure of retention. Adherence to the program will be defined as the proportion of weekly modules completed (adequate adherence is defined as completion of ≥ 75% of modules, or 6 of the total 8 modules).

  Week 18

• Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate

  To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.

  Baseline

• Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate

  To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.

  Week 10

• Acceptability - proportion of eligible participants screened and the proportion of eligible participants who consent to participate

  To assess the acceptability of painTRAINER among Spanish speaking participants, the study will determine the ability to recruit participants into the pilot trial via networks of community partners in the Atrium Health: Wake Forest Baptist catchment area. To characterize our ability to recruit participants, the study will estimate the proportion of eligible participants screened and the proportion of eligible participants who consent to participate. The study also will closely monitor the rate of referrals to the program by providers. Acceptability of the program also will be assessed more subjectively via interviews with participants following completion of or termination from the pilot trial.

  Week 18

Secondary Outcomes (7)

• Change in Pain interference scores

  baseline, 10 weeks, 18 weeks

• Change in Pain severity scores

  baseline, 10 weeks, 18 weeks

• Change in Fatigue scores

  baseline, 10 weeks, 18 weeks

• Change in Sleep disturbance scores

  baseline, 10 weeks, 18 weeks

• Change in Pain resilience scores

  baseline, 10 weeks, 18 weeks

Study Arms (1)

painTRAINER intervention

EXPERIMENTAL

40 Spanish speaking Hispanic and Latine participants will participate in an 8 week online pain coping skills training program designed to address cancer-related pain.

Behavioral: painTRAINER

Interventions

painTRAINER BEHAVIORAL

painTRAINER is an 8 week online behavioral pain coping skills training program derived from cognitive behavioral therapy approaches, which includes 45 minute behavioral coping sessions to be completed over 8 weeks. Weekly sessions are guided by an automated coach that teaches skills for coping with pain.

painTRAINER intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cancer Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Donald B Penzien, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non-random pilot trial with no masking due to single group assignment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group pilot study to assess feasibility and acceptability.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: July 27, 2023
• Primary Completion: May 7, 2024
• Study Completion: December 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)