NCT05775991

Brief Summary

To gather key stakeholder input for feedback on the adaption of the COACH GA intervention (i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care partners and patients with ADRD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

January 20, 2023

Results QC Date

September 12, 2024

Last Update Submit

November 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Qualitative Analysis of Focus Group Audio-recording Transcripts. Open Coding Using Content Analysis Framework Will be Utilized to Assess Positive Regard for the Intervention and Potential Intervention Adaptations.

    Qualitative data gathered from participants during focus group participation. Focus groups will be audio-recorded and transcribed. Transcribed audio-recordings will be qualitatively analyzed for positive regard for the intervention and opportunities and recommendations for further intervention adaptation. Open coding using content analysis framework will be utilized for qualitative analysis.

    Through study completion approximately 3 months

Study Arms (3)

Medical Oncologists and Clinicians

Individuals practicing as medical oncologists or with expertise in medical oncology. Clinicians with expertise in cognitive impairment and dementia

Older patients with cancer

Older patients with cancer or older survivors of patients with cancer

Caregivers of patients with dementia or cognitive impairment

Caregivers of patients with dementia or cognitive impairment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Focus groups will be conducted with the following stakeholders: 1. Medical oncologists 2. Clinicians with expertise in cognitive impairment and dementia 3. Older patients with cancer 4. Caregivers of patients with dementia

You may not qualify if:

  • For the medical oncologist focus group, participants must be a medical oncologist.
  • For the clinicians with expertise in cognitive impairment and dementia focus group, participants must be a clinician that treats patients with cognitive impairment and dementia.
  • For the older patients with cancer focus group, participants must be older than 65 years of age and have or had cancer.
  • For the caregivers of patients with dementia focus group, participants must be caregivers of patients with dementia or cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Wilmot Cancer Institute

Rochester, New York, 14620, United States

Location

Results Point of Contact

Title
Dr. Allison Magnuson
Organization
University of Rochester

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 20, 2023

First Posted

March 20, 2023

Study Start

March 15, 2023

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

December 11, 2024

Results First Posted

December 11, 2024

Record last verified: 2024-11

Locations