Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790538
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-02-23
Brief Title:
Predicting the Impact of Treatment Toxicities on Health During Cancer PATTERN
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
PATTERN Predicting the Impact of Treatment Toxicities on Health During Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATTERN
Brief Summary:
This study investigates the effects of treatment from chemotherapy for cancer on symptoms function and falls during treatment and through the recovery phase of cancer care The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and functional decline and informing rehabilitation providers about which mobility deficits to target
Detailed Description:
Aggressive treatments for cancer have improved survival but often cause serious long-term adverse effects on daily life that last for many years Chemotherapy-induced peripheral neuropathy CIPN is a persistent cancer treatment-related symptom that may negatively impact physical functioning falls and quality of life
The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care A critical first step toward filling this gap is to characterize the natural trajectories of symptoms functioning and falls across the in-treatment and recovery phases of cancer care
This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health Science University 5 OHSU Knight Cancer Institute community hematology-oncology clinics and OHSU research affiliate sites Data collection occurs at patients routine clinical appointments and at home via electronic surveys and passive monitoring devices In the clinic data collection occurs at 4-6 week intervals during treatment according to each patients infusion schedule and then approximately every 3 months for an additional year during routine follow-up care Clinic-based assessments include tests of perceived sensation tuning fork monofilament and biothesiometer upper body strength handgrip dynamometry lower body strength chair stand test static balance postural sway and dynamic balance Timed Up and Go test Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys At time points corresponding to clinic testing visits participants are sent home with passive monitoring devices instrumented socks and wrist-worn activity monitors that measure physical activity and mobility
PRIMARY OBJECTIVE
I To characterize trajectories of chemotherapy induced peripheral neuropathy CIPN symptoms and physical functioning physical activity mobility self-report functioning and disability and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer
SECONDARY OBJECTIVE
I Determine whether or not patient characteristics alone can predict symptom and functioning trajectories or if adding clinical factors and simple tests of mobility significantly improves predictive capacity
OUTLINE
Patients complete surveys and clinic assessments at baseline every 4-6 weeks during chemotherapy and then every 3 months for 1 year after completion of chemotherapy Clinic assessments include tests of neuropathy upper and lower body strength balance and mobility Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy Patients medical records are also reviewed
The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care A critical first step toward filling this gap is to characterize the natural trajectories of symptoms functioning and falls across the in-treatment and recovery phases of cancer care
This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health Science University 5 OHSU Knight Cancer Institute community hematology-oncology clinics and OHSU research affiliate sites Data collection occurs at patients routine clinical appointments and at home via electronic surveys and passive monitoring devices In the clinic data collection occurs at 4-6 week intervals during treatment according to each patients infusion schedule and then approximately every 3 months for an additional year during routine follow-up care Clinic-based assessments include tests of perceived sensation tuning fork monofilament and biothesiometer upper body strength handgrip dynamometry lower body strength chair stand test static balance postural sway and dynamic balance Timed Up and Go test Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys At time points corresponding to clinic testing visits participants are sent home with passive monitoring devices instrumented socks and wrist-worn activity monitors that measure physical activity and mobility
PRIMARY OBJECTIVE
I To characterize trajectories of chemotherapy induced peripheral neuropathy CIPN symptoms and physical functioning physical activity mobility self-report functioning and disability and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer
SECONDARY OBJECTIVE
I Determine whether or not patient characteristics alone can predict symptom and functioning trajectories or if adding clinical factors and simple tests of mobility significantly improves predictive capacity
OUTLINE
Patients complete surveys and clinic assessments at baseline every 4-6 weeks during chemotherapy and then every 3 months for 1 year after completion of chemotherapy Clinic assessments include tests of neuropathy upper and lower body strength balance and mobility Patients complete weekly symptom surveys and wear instrumented socks and an activity monitor at regular intervals at home during chemotherapy treatment and for 1 year after completion of chemotherapy Patients medical records are also reviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-05944 | REGISTRY | None | None |
| STUDY00021969 | OTHER | None | None |
| R01CA248059 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchR01CA248059 |