NCT07042191

Brief Summary

The overall goal of this research program is to address financial toxicity through the development, testing, and implementation of a multi-level communication intervention. If successful, this intervention could be a companion intervention for Cancer providers in combination with the already in testing DISCO app (Discussions of Cost App) for patients. Participants will:

  • complete a baseline survey
  • attend two one on one meetings, one as part of the development and the second as part of the pilot testing of the intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
11mo left

Started Dec 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Dec 2022May 2027

Study Start

First participant enrolled

December 9, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 27, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

May 23, 2025

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptability - Qualitative report

    Success of intervention measured by semi-structured qualitative interview method which addresses acceptability

    Immediately Post Pilot Test

  • Usability-Qualitative Report

    Success of intervention measured by semi-structured qualitative interview method which addresses usability

    Immediately post pilot test

  • Usefulness-Qualitative Report

    Success of intervention measured by semi-structured qualitative interview method which addresses usefulness

    Immediately Post Pilot Test

Study Arms (1)

DISCO (Discussions of Cost) Provider Companion Intervention

EXPERIMENTAL

Providers of Cancer patients at Karmanos Cancer Institute will use the DISCO (Discussion of Cost) provider communication intervention to assess its feasibility, acceptability, and usability

Behavioral: Disco (Discussion of Cost) Provider Companion Intervention

Interventions

A communication intervention for providers to assess financial toxicity in Cancer patients

DISCO (Discussions of Cost) Provider Companion Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Oncology care providers at Karmanos Cancer Institute (KCI)/Wayne State University(WSU) including medical oncologists, nurses, social workers and advance practice providers who treat cancer patients at KCI Detroit or Farmington Hills clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Lauren M Hamel, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren M Hamel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 27, 2025

Study Start

December 9, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 27, 2025

Record last verified: 2025-05

Locations