Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06281145
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Brief Title:
Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer
Sponsor:
Comenius University
Organization:
Comenius University
Study Overview
Official Title:
A Study on Therapeutic Potential of Stress-Reducing Intervention in Patients With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-02
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:
SRI-BrCa_CRC
Brief Summary:
The goal of this interventional study is to test the heart-rate variability biofeedback intervention HRV BI in 2 cohorts of patients Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting vs standard of care alone SOC followed by local therapy surgery -radiotherapy Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting vs standard of care alone SOC
Detailed Description:
This is a prospective interventional clinical study with in 2 cohorts Target of subjects is 50 per cohort and an anticipated total duration of 36 months
Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain and how to perform deep paced breathing with the HRV monitoring They will perform the training daily 3-times minimum 7 minutes each at home with the online control for 3 months
Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation HRV quality of life QoL cognitive functions salivary cortisol slopes sleep quality and treatment outcomes of patients with colorectal and breast cancer
Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain and how to perform deep paced breathing with the HRV monitoring They will perform the training daily 3-times minimum 7 minutes each at home with the online control for 3 months
Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation HRV quality of life QoL cognitive functions salivary cortisol slopes sleep quality and treatment outcomes of patients with colorectal and breast cancer
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