Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05677802
Status:
RECRUITING
Last Update Posted:
2023-01-10
First Post:
2022-12-15
Brief Title:
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2022-12
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:
None
Brief Summary:
This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs eg utilities transportation etc The stress reduction program is over ten weeks and includes stress reduction eg progressive muscle relaxation coping problem solving communication and social support Health related social needs will be evaluated at the beginning of the study and referrals will be made to social work to help address those needs The study will examine stress as reported by the patients and also use biological markers
Detailed Description:
PRIMARY OBJECTIVES
I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire CSQ CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction eg quality of service the degree to which needs were met overall satisfaction
III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States
III Feasibility of the biobehavioral intervention will be assessed using three metrics 1 accrual number as a percentage of available patients approached 2 numberpercent of patients completing each BBI session and 3 numberpercent of patients retained and completing 10 BBI sessions
SECONDARY OBJECTIVE
I To examine the feasibility of collecting biomarkers--white blood cell count C-reactive protein Interleukin-6 TNF-alpha α systolic blood pressure diastolic blood pressure heart rate total cholesterol high-density lipoprotein albumin hemoglobin A1C body mass index BMI
EXPLORATORY OBJECTIVE
I To test for prepost effects of the biobehavioral stress reduction intervention on measures of stress Impact of Events Scale mood and psychological symptoms and allostatic load
OUTLINE
Patients receive biobehavioral stress reduction intervention while on study Patients undergo blood specimen collection at baseline and follow up and have their medical records reviewed
I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire CSQ CSQ is an 8-item self-report measure with item assessing different aspects of treatment satisfaction eg quality of service the degree to which needs were met overall satisfaction
III Tolerability of the biobehavioral intervention will be assessed by analyzing pre to post treatment change on the Profile of Mood States
III Feasibility of the biobehavioral intervention will be assessed using three metrics 1 accrual number as a percentage of available patients approached 2 numberpercent of patients completing each BBI session and 3 numberpercent of patients retained and completing 10 BBI sessions
SECONDARY OBJECTIVE
I To examine the feasibility of collecting biomarkers--white blood cell count C-reactive protein Interleukin-6 TNF-alpha α systolic blood pressure diastolic blood pressure heart rate total cholesterol high-density lipoprotein albumin hemoglobin A1C body mass index BMI
EXPLORATORY OBJECTIVE
I To test for prepost effects of the biobehavioral stress reduction intervention on measures of stress Impact of Events Scale mood and psychological symptoms and allostatic load
OUTLINE
Patients receive biobehavioral stress reduction intervention while on study Patients undergo blood specimen collection at baseline and follow up and have their medical records 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-08781 | REGISTRY | CTRP Clinical Trial Reporting Program | None |