NCT07737314

Brief Summary

This clinical trial will evaluate the feasibility, acceptability, and potential efficacy of a palliative care pharmacist-led group telehealth opioid education session for palliative care patients prescribed opioids for cancer-related pain. While opioids are commonly used in palliative care settings to manage cancer-related pain, their significant side effects, complicated administration requirements, and concerns about addiction can make it challenging for patients to use opioids safely and effectively. Some patients may even avoid opioids altogether because of these concerns, even when opioids are clinically indicated, leading to poor symptom control. To address these challenges, a telehealth education session was developed as a clinical initiative by a palliative care pharmacist, addressing safe and effective opioid management. Educational priorities and session content were informed by a survey of interdisciplinary palliative care clinicians that identified barriers and facilitators to opioid education and key patient educational needs. Patients scheduled to attend a pharmacist-led group telehealth opioid education session who enroll in the study will complete a survey before the session and another survey afterward. This study will assess the feasibility and acceptability of delivering the intervention, as well as its preliminary effects on opioid knowledge and self-efficacy. If feasible and acceptable, this pharmacist-led telehealth education model could represent a scalable strategy to improve opioid management for patients with cancer-related pain.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Nov 2026

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage of referred patients who attend pharmacist education session (Feasibility)

    Feasibility of the pharmacist education session will be interpreted as an overall session attendance-to-referral rate ≥ 50%.

    Up to 6 months

  • Participant score on the "general acceptability" item of the Theoretical Framework of Acceptability questionnaire

    Assessed on post-session surveys, delivered within 7 days after session attendance, with up to one month of follow-up to encourage survey completion. Acceptability of the pharmacist education session will be interpreted as \> 70% respondents rating the sessions as ≥ 4/5 (i.e. "acceptable" or "completely acceptable") on the "general acceptability" item of the Theoretical Framework of Acceptability scale (5 point Likert scale), assessed on the post-session survey.

    Up to 1 month post-session

Study Arms (1)

Supportive care (pharmacist-led opioid education session)

EXPERIMENTAL

Patients scheduled to attend a pharmacist-led group telehealth opioid education session who enroll in the study will complete a survey before the session and another survey afterward. After attending the pharmacist education session, patients will receive a patient education handout summarizing the educational content.

Other: Survey AdministrationOther: Electronic Health Record Review

Interventions

Ancillary studies - pre- and post-session surveys to assess opioid knowledge and self-efficacy, and post-session to assess session acceptability

Supportive care (pharmacist-led opioid education session)

Ancillary studies

Supportive care (pharmacist-led opioid education session)

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years, consistent with the population of patients treated at Fred Hutch Cancer Center
  • A cancer diagnosis
  • Established care in the Fred Hutch Palliative Care Clinic (≥ 1 visit with a Fred Hutch palliative care physician or advanced practice provider within the past 12 months)
  • Prescribed opioids, defined as either ≥ 1 opioid prescription within the past 6 months documented in the Washington Prescription Drug Monitoring Program (PDMP), or a new opioid prescription initiated by the referring palliative care provider at the time of referral
  • Ability to understand and willingness to agree to an electronic consent document
  • Enrolled in MyChart and ability to participate in a telehealth video visit

You may not qualify if:

  • Patients who prefer a language other than English for healthcare, as the session will be conducted live and cannot currently be offered in other languages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Study Officials

  • Nicole Dussault, MD, MS

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

This study will generate quantitative and qualitative human subjects data as part of a pilot evaluation of a palliative care pharmacist-led group telehealth opioid education session intervention for patients with cancer pain. Quantitative data will include structured survey responses and electronic health record data. The shared data package will include de-identified quantitative datasets, qualitative data files where appropriate, data dictionaries/codebooks, and copies of study instruments, subject to instrument licensing requirements. De-identified datasets will be preserved and shared via a suitable repository that supports health-related research data, such as a general-purpose repository (e.g., Dryad or Figshare) or an institutional repository supported by Fred Hutchinson Cancer Center. The selected repository will provide persistent identifiers (e.g., DOIs) to support citation and long-term access.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available no later than the time of publication of the primary study results or within 12 months of completion of the project period, whichever occurs first.
Access Criteria
Shared data will be made available with minimal access restrictions, consistent with protecting participant privacy and honoring informed consent. Data will be licensed to permit reuse for non-commercial research purposes, including secondary analyses, methodologic studies, and meta-analyses, with appropriate citation of the original dataset and investigators. Users of the data will be required to acknowledge the data source in publications and presentations. No attempt will be made to re-identify study participants, and no data will be shared that could reasonably place participants at risk of deductive disclosure.

Locations