NCT07093567

Brief Summary

To explore the barriers and fears related to use of opioids among a population of adult outpatients with advanced cancer who continue to experience pain after receiving a prescription for opioid analgesia and hypothesized associations among opiophobia, anxiety, depression, pain intensity, pain interference, and opioid medication adherence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
54mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Aug 2025Jan 2031

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

July 23, 2025

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Barriers Questionnaire (BQ-13)

    Through study completion; an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MD Anderson Cancer Center

You may qualify if:

  • Adult patients with advanced cancer (defined as cancer that is unlikely to be cured and is locally advanced or distantly metastasized
  • Pain is the documented reason for the Supportive Care consultation
  • Have a prescription for an opioid analgesic
  • Able to read, speak, and consent in English.

You may not qualify if:

  • Age less than 18 years
  • Do not have a prescription for an opioid analgesic
  • Individuals for whom there is documentation of inability to provide consent in the medical record
  • Women who are pregnant
  • Patients with a substance use disorder (including alcohol use disorder and excluding tobacco use disorder) documented in the electronic health record under History of Present Illness or in the Medical History.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Eileen Hacker, PHD, RN

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations