Breast CancerGAPNCT06125145
Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study
A study testing Geriatric Assessment and Promotora Coaching in people with Breast Cancer and Colorectal Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a new way to help older adults who have had cancer. The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Geriatric Assessment and Promotora Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65-90
- Able to understand study procedures and to comply with them for the entire length of the study.
- Diagnosis of Stage II-III breast, colorectal, or prostate cancer in within 1 to 24 months.
- Completed course of definitive therapy within 12 months from enrollment into the study.
- Proficient in English or Spanish
- Reside within the UC Davis Health catchment area.
- Has self-reported primary caregiver aged 21-90 years.
Who cannot join
- Contraindication to any study-related procedure or assessment.
- Patient is unable to independently deliver informed consent.
- Patient screens positive for cognitive impairment (6CIT > 8)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Tailored Geriatric Assessment and Promotores Pilot Feasibility Study
The goal of this clinical trial is to test a new way to help older adults who have had cancer.
The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.
Read the detailed description
The proposed study is a single arm feasibility study of a supportive care intervention. Phase is not applicable because this is not a drug trial. The study involves enrolling older adult non-metastatic cancer survivors between 1 month and 24 months after the completion of any definitive (e.g., curative intent) cancer treatment. The objective is to determine if a Community Health Worker (CHW)-led geriatric assessment and coaching intervention to assess geriatric syndromes is a feasible modality in community-dwelling older adult cancer survivors. The tailored assessment intervention (geriatric assessment and coaching) is hypothesized to potentially be a feasible process to monitor patients that would otherwise not access geriatric services after completing cancer treatment. Coping and social support are hypothesized mediators to the relationship between physical function and health outcomes (e.g., physical function, mental health), influenced by sociodemographic contextual factors. Implementation science concepts, such as acceptability and scalability will also be collected. The study CHW will perform the geriatric assessment and coaching components with each of the patients in the study. The assessment component of the bundle intervention involves screening for frailty and cognition, occurring prior to the coaching session. The CHW will conduct a more thorough geriatric assessment for polypharmacy, depression, symptom burden, and social support. In follow up visits after the geriatric assessment the CHW will deliver the coaching component (derived from the Problem Solving Coaching Model) to participants. Each of the intervention sessions will consist of 45-minute appointments with tailored feedback of the geriatric assessment domains, caregiver and family support, and navigation to additional palliative care resources at the study institution. The researchers developed the content in the tailored assessment intervention from preliminary work and thorough review of scientific literature.
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- Geriatric Assessment and Promotora Coaching
- Keywords
- geriatrics, frailty, community health workers
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Assessment and Promotora CoachingBehavioural
In Visit 1 the community health worker/promotora will assess frailty, cognition, polypharmacy, depression, symptom burden, and social support. In Visits 2 and 3 the community health worker will deliver interpersonal communication techniques to deliver the problem solving coaching format, leverage cultural congruence with clients, and provide social support to assist in adopting healthy behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Arm | Experimental | All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention. Receives: Behavioral: Geriatric Assessment and Promotora Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the percentage of participants that complete 2 out of 3 study visits
Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)
Measured: 6 month
Secondary outcomes (5)
Physical Function
Patient-Reported Outcomes Measurement Information System [PROMIS] Physical Function
Measured: Baseline to 6 month
Depression, Anxiety, and Fatigue
Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, Anxiety, and Fatigue
Measured: Baseline to 6 month
Self-Efficacy
Patient-Reported Outcomes Measurement Information System [PROMIS] Self-Efficacy
Measured: Baseline to 6 month
Emotional Support
Patient-Reported Outcomes Measurement Information System [PROMIS] Emotional Support
Measured: Baseline to 6 month
Quality of Life in Elderly Cancer Patients
European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire in the Elderly 14 item questionnaire [QLQ-ELD14]. Range 0 to 100, higher scores indicate better quality of life.
Measured: Baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start19 Apr 2024
- Primary completion10 May 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alex Fauer, PhD MS, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125145
- Sponsor's protocol ID
- 1943526
- Other IDs
- 5K12CA138464
- Acronym
- GAP
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Geriatric Assessment and Promotores Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06125145
- Acronym / sponsor ID
- GAP / 1943526
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Keywords
- geriatrics, frailty, community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a new way to help older adults who have had cancer.
The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.
Detailed description
The proposed study is a single arm feasibility study of a supportive care intervention. Phase is not applicable because this is not a drug trial. The study involves enrolling older adult non-metastatic cancer survivors between 1 month and 24 months after the completion of any definitive (e.g., curative intent) cancer treatment. The objective is to determine if a Community Health Worker (CHW)-led geriatric assessment and coaching intervention to assess geriatric syndromes is a feasible modality in community-dwelling older adult cancer survivors. The tailored assessment intervention (geriatric assessment and coaching) is hypothesized to potentially be a feasible process to monitor patients that would otherwise not access geriatric services after completing cancer treatment. Coping and social support are hypothesized mediators to the relationship between physical function and health outcomes (e.g., physical function, mental health), influenced by sociodemographic contextual factors. Implementation science concepts, such as acceptability and scalability will also be collected. The study CHW will perform the geriatric assessment and coaching components with each of the patients in the study. The assessment component of the bundle intervention involves screening for frailty and cognition, occurring prior to the coaching session. The CHW will conduct a more thorough geriatric assessment for polypharmacy, depression, symptom burden, and social support. In follow up visits after the geriatric assessment the CHW will deliver the coaching component (derived from the Problem Solving Coaching Model) to participants. Each of the intervention sessions will consist of 45-minute appointments with tailored feedback of the geriatric assessment domains, caregiver and family support, and navigation to additional palliative care resources at the study institution. The researchers developed the content in the tailored assessment intervention from preliminary work and thorough review of scientific literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility Arm | Experimental | Behavioral: Geriatric Assessment and Promotora CoachingAll enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65-90
- Able to understand study procedures and to comply with them for the entire length of the study.
- Diagnosis of Stage II-III breast, colorectal, or prostate cancer in within 1 to 24 months.
- Completed course of definitive therapy within 12 months from enrollment into the study.
- Proficient in English or Spanish
Key exclusion criteria (3 listed)
- Contraindication to any study-related procedure or assessment.
- Patient is unable to independently deliver informed consent.
- Patient screens positive for cognitive impairment (6CIT > 8)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Assessment and Promotora CoachingIn Visit 1 the community health worker/promotora will assess frailty, cognition, polypharmacy, depression, symptom burden, and social support. In Visits 2 and 3 the community health worker will deliver interpersonal communication techniques to deliver the problem solving coaching format, leverage cultural congruence with clients, and provide social support to assist in adopting healthy behaviors. | Behavioural | Feasibility Arm |
Primary outcome
Describe the percentage of participants that complete 2 out of 3 study visits
Time frame: 6 month
Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)
5 secondary outcomes
Physical Function
Time frame: Baseline to 6 month
Depression, Anxiety, and Fatigue
Time frame: Baseline to 6 month
Self-Efficacy
Time frame: Baseline to 6 month
Emotional Support
Time frame: Baseline to 6 month
Quality of Life in Elderly Cancer Patients
Time frame: Baseline to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Alex Fauer, PhD MS principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assessment and Promotora Coaching in people with Breast Cancer and Colorectal Cancer, run by University of California, Davis 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 7 inclusion and 3 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 5 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Describe the percentage of participants that complete 2 out of 3 study visits (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.