University of California, Davis
Sacramento, California, 95817, United States
NCT Number: NCT06125145
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.
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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Sacramento, California, 95817, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 month
Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)
Time frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Physical Function
Time frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, Anxiety, and Fatigue
Time frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Self-Efficacy
Time frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Emotional Support
Time frame: Baseline to 6 month
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.
University of California, Davis
Other
Tailored Geriatric Assessment and Promotores Pilot Feasibility Study
Acronym: GAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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