NCT07852468

Brief Summary

This is a Stage 1 study of a behavioral intervention, which means that a new intervention is being pilot tested to understand whether it is acceptable and feasible for people with advanced cancer to use. The purpose of this study is to evaluate whether a series of 3 10-minute videos may help improve prescription opioid pain management and opioid stigma for people living with advanced cancer. Approximately 45 participants will take part in this study at the University of Alabama at Birmingham. People who choose to participate in this study will complete a series of baseline questionnaires, and then will be randomized to one of two groups: 1) the group that gets the video intervention, or 2) the group that gets a written handout with information about cancer pain. About 4 weeks later, all participants will also be asked to fill out another series of questionnaires.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
7mo left

Started Oct 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026May 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

cancer painadvanced cancerdigital interventionpain management

Outcome Measures

Primary Outcomes (1)

  • Participants who watch at least one video

    Count participants who watch at least one video

    4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to the intervention group will have access to three 10-minute videos through a digital application. The videos cover cancer pain, pain medications, and pain self-management skills, and will be available for four weeks.

Behavioral: Cancer Pain 101

Educational Control

NO INTERVENTION

Participants in the educational control condition will receive a written handout about cancer pain, which is widely available and published by the American Cancer Society; they will not have access to the intervention videos.

Interventions

Cancer Pain 101BEHAVIORAL

The study intervention is Cancer Pain 101. Cancer Pain 101 is a 3-part educational video series, designed to be delivered asynchronously. Each video is approximately 10 minutes long and is narrated by a multidisciplinary team, including a psychologist, oncologist, palliative care clinician, and pharmacist.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years old
  • speaks English
  • current, advanced solid tumor cancer diagnosis (stage III or IV)
  • endorses cancer-related pain (e.g,. pain, that began, worsened, and/or changed during cancer)
  • current opioid prescription OR planning to initiate opioids for cancer pain management

You may not qualify if:

  • observable psychiatric disorders that would interfere with study participation (e.g., dementia, psychosis)
  • inability to speak and read English
  • inability to provide informed consent
  • prior participation in aspects of this study (i.e., K08 Aims 1 and 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • Bulls HW, Hamm M, Wasilko R, de Abril Cameron F, Belin S, Goodin BR, Liebschutz JM, Wozniak A, Sabik LM, Merlin JS, Schenker Y. Manifestations of Opioid Stigma in Patients With Advanced Cancer: Perspectives From Patients and Their Support Providers. JCO Oncol Pract. 2022 Oct;18(10):e1594-e1602. doi: 10.1200/OP.22.00251. Epub 2022 Jul 25.

    PMID: 35878073BACKGROUND
  • Bulls HW, Chu E, Goodin BR, Liebschutz JM, Wozniak A, Schenker Y, Merlin JS. Framework for opioid stigma in cancer pain. Pain. 2022 Feb 1;163(2):e182-e189. doi: 10.1097/j.pain.0000000000002343.

    PMID: 34010940BACKGROUND

MeSH Terms

Conditions

NeoplasmsPainCancer PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Hailey W Bulls, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

The proposed research will include data from a total of 120 patients (75 Aims 1 and 2; 45 Aim 3) with advanced cancer. The final dataset will include self-reported demographic data and survey data from pilot trial assessments. All data in our analysis will be deidentified. No identifying information will be retained past the conclusion of the K08 study period. The data collected will be used for publication purposes and will be made available for public use upon completion of our study and the initial dissemination of our research results. Any data shared will be de-identified.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations