Focus GroupsNCT05775991

COACH-Cog Intervention Adaptation Focus Groups

An observational study of Focus Groups, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Focus Groups
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2023to 12 Sep 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

The inclusion and exclusion criteria for participants are that they must be able to consent for themselves and must speak English.
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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Wilmot Cancer Institute
Rochester, New York, 14620

Other trials in United States

About this study

Official title: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision - Focus Groups

Conditions: Focus Groups

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05775991
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through study completion approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202312 Sep 2023

First posted20 Mar 2023
Study start15 Mar 2023
Primary completion12 Sep 2023
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Focus GroupsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05775991
Sponsor's protocol ID: UOCPC22008
Other IDs: R01AG077053
Status last verified: Nov 2024
First submitted: 20 Jan 2023
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Focus Groups trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision - Focus Groups
ClinicalTrials.gov ID: NCT05775991
Acronym / sponsor ID: UOCPC22008
Conditions: Focus Groups
Study type: Observational
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 15 Mar 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 20 Mar 2023 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (5 listed)

The inclusion and exclusion criteria for participants are that they must be able to consent for themselves and must speak English.
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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
Time frame: Through study completion approximately 3 months
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.

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Oncologists and Clincians	5	5
Older Patients With Cancer	4	4
Caregivers of Patients With Dementia or Cognitive Impairment	9	7

Primary outcome: 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.

Time frame: Through study completion approximately 3 months. Count of participants. Unit: Participants

Measure	Medical Oncologists and Clinicians n = 5	Older Patients With Cancer n = 4	Caregivers of Patients With Dementia or Cognitive Impairment n = 9
Positive Quote Given	4	3	4
Negative Quote Given	0	0	0
No Quote Given Applicable	1	1	3
Withdrew	0	0	2

Adverse events

Time frame: We collected data on any adverse events that occur during the focus group that are attributable to the focus group which was 1 week in duration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medical Oncologists and Clinicians	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Older Patients With Cancer	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Caregivers of Patients With Dementia or Cognitive Impairment	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Focus Groups, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Through study completion approximately 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05775991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.