Supportive Care
OtherGeriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
NCT Number: NCT07175376
The study purpose is to gain a better understanding of the needs of adults aged 65 and older while they are receiving chemotherapy by measuring their resilience and tailor care plans based on their individual needs.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Levine Cancer Institute, Charlotte, North Carolina, United States
This is a prospective single-arm intervention trial of patients aged 65 or older with an active cancer diagnosis who are planned to receive chemotherapy and are eFI (Electronic Health Record (EHR)-based frailty index) pre-frail or frail.
Patients will be enrolled before initiation of chemotherapy. Following a baseline assessment, subjects will be provided with results regarding their frailty, will be offered referrals for supportive care interventions and will participate in weekly symptom reporting (electronic survey + phone call from research nurse) for 12 weeks. Follow-up assessments will be completed at 12 weeks and a subset of participants and providers in participating clinics will be contacted to consent and participate in an interview to provide feedback on the intervention including barriers/facilitators.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with cancer:
Providers:
Exclusion criteria
Patients:
Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
Time frame: Enrollment
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
Time frame: At 12 weeks after initiation of standard of care chemotherapy
The proportion of enrolled patient participants who complete Visit 2 out of the total number of patient participants who were enrolled and initiate chemotherapy
Time frame: Weeks 1 to 12
The total number of weekly assessments completed out of the total number of weekly assessments among participants who enroll and initiate chemotherapy.
Time frame: Baseline to Week 12
Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation
Time frame: Baseline to Week 12
Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation
Contact information is provided by the study sponsor or research team.
Wake Forest University Health Sciences
Other
Resilience Enhancement Utilizing an Electronic Frailty Index-Directed Care Pathway for Older Adults Receiving Chemotherapy (RESILIENCE-e): A Prospective Single-Arm Interventional Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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