Evaluating Feasibility and Acceptability of Pain Education

NCT07869420 | Completed DMC

• 4 other identifiers: Cancer Pain 101 (Pilot)U54GM104938K08CA266937P30CA225520
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to implement a healthy, non-invasive therapeutic alternative for managing cancer-related pain in chronic cancer patients (Cancer Pain 101). This pilot trial will investigate the feasibility and effectiveness of implementing this approach through a single session, with the goal of helping patients improve their pain control and pain-related quality of life.

Conditions

Cognitive Coping; Cancer

Keywords

CBT; Cancer Pain 101

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Who engage in Cancer Pain 101 intervention attendance.

  The primary aim of this study is to determine the feasibility of the Cancer Pain 101 behavioral intervention. Feasibility will be assessed based on several measures, including primarily the proportion of patients who attend the telehealth Cancer Pain 101 intervention, in addition to time to accrual, participation rates, and survey completion rates. Feasibility will be considered demonstrated if more than 70% of enrolled patients participate in the telehealth intervention.

  1 Year

• Percentage of Patient Who reported acceptability of The Cancer Pain 101 Intervention.

  Acceptability will be assessed using participant questionnaire responses. The intervention will be considered acceptable if more than 80% of participants rate the questionnaire items greater than 4 out of 5.

  1 Year

Study Arms (3)

Pilot Trial

ACTIVE COMPARATOR

During the pilot trial, 60 evaluable patients with chronic cancer-related pain will participate in a 90-minute Cancer Pain 101 class focused on behavioral, non-invasive strategies for managing cancer-related pain. Surveys will be completed at baseline and at 2- and 4-week follow-ups. The first outcome will assess the feasibility, acceptability, and perceived usefulness of the intervention. For the second outcome, researchers will use data collected during Aim 1 to examine changes in pain severity, opioid use, pain management, and quality of life compared with baseline measures. The goal is to determine whether participation in Cancer Pain 101 is associated with improved pain control, reduced opioid use, and improved pain-related quality of life.

Other: Cancer Pain 101

Intervention Group Cohort A Cancer Pain 101

EXPERIMENTAL

Aim 3 of this trial will serve as a randomized pilot trial consisting of two cohorts and will include 60 evaluable patients total amongst the two cohorts. Participants randomized to Cohort A will attend a 90-minute Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life.

Other: Cancer Pain 101

Intervention Group Cohort B CBT

EXPERIMENTAL

Cohort B will serve as the control group. Patients randomized to this cohort will receive an informational packet containing educational materials on cancer-related pain from the American Cancer Society (ACS). Participants in Cohort B will not attend the Cancer Pain 101 intervention class. Surveys will be administered at baseline and again at 2- and 4-week follow-up time points to assess changes in pain management, pain severity, and quality of life.

Other: Pharmacotherapy Informational Packet

Interventions

Cancer Pain 101 OTHER

This is a 90-minute virtual class led by the Principal Investigator (PI) and the investigational team. The class will cover all six traditional pain-focused cognitive behavioral therapy (CBT) modules referenced in the study protocol. Due to the limited session time, all educational materials and references used during the class are standard-of-care resources.

Intervention Group Cohort A Cancer Pain 101; Pilot Trial

Pharmacotherapy Informational Packet OTHER

Patients randomized to Cohort B will receive a informational packet of cancer-pain educational materials provided by the American Cancer Society.

Intervention Group Cohort B CBT

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• Have chronic pain related to cancer (\> 4/10 average pain score in the past two weeks)
• Receiving active cancer treatment or recently completed treatment (within the past 3 months)

You may not qualify if:

• Inability to speak/read English
• Cognitive impairment significant enough to impair participation in study procedures (e.g. delirium/dementia)

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Azizoddin Desiree, PsyD

  Dana Farber Cancer Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 90-Min Single-Session introducing pain education and cognitive behavioral therapy.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: July 22, 2024
• Primary Completion: October 9, 2024
• Study Completion: November 30, 2024
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

US (1)