Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05677802
Other study ID # OSU-22083
Secondary ID NCI-2022-08781
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2022
Est. completion date December 31, 2024

Study information

Verified date December 2022
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., 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.


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 (e.g., 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) number/percent of patients completing each BBI session; and, 3) number/percent 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 pre/post 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >=18 years - Untreated newly diagnosed triple negative breast cancer - Stages I-III Exclusion Criteria: - Prisoners - Male - Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander - Individuals not able to speak and understand English - Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer - Stage IV breast cancer

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Other:
Medical Chart Review
Undergo medical cart review
Procedure:
Stress Management Therapy
Receive biobehavioral stress reduction intervention
Other:
Survey Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of the biobehavioral intervention Acceptability will be measured at the end of the intervention using the Client Satisfaction Questionnaire (CSQ). CSQ scores range from 8-32 with higher scores indicating higher satisfaction. Up to 2 years
Primary Tolerability of the biobehavioral intervention This will be assessed analyzing pre to post treatment change on the Profile of Mood States short form. The Profile of Mood States short from is a 37 item survey with lower scores indicative of stable mood. Up to 2 years
Primary Feasibility biobehavioral intervention Feasibility will be evaluated using three metrics: 1) accrual number as a percentage of available patients approached; 2) number/percent of patients completing each Biobehavioral intervention (BBI) session; and, 3) number/percent of patients retained and completing 10 BBI sessions. Up to 2 years
Secondary Completeness of biomarkers collected to calculate allostatic load The completeness of the 12 study biomarkers (white blood cell count, C-reactive protein, Interleukin-6, TNF-alpha (a), systolic blood pressure, diastolic blood pressure, heart rate, total cholesterol, high-density lipoprotein; albumin, hemoglobin A1C, body mass index (BMI)) will be assessed pre and post intervention Up to 2 years
See also
  Status Clinical Trial Phase
Suspended NCT05673200 - Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer Phase 1
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Completed NCT04535323 - Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer Phase 1
Recruiting NCT05464810 - Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Early Phase 1
Active, not recruiting NCT04249622 - Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer Phase 2
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Not yet recruiting NCT05930483 - Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors N/A
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Withdrawn NCT05967286 - Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial Phase 2
Recruiting NCT04593277 - Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study N/A
Active, not recruiting NCT05086731 - Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer N/A
Recruiting NCT05368428 - Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer N/A
Recruiting NCT04673448 - Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Not yet recruiting NCT05539365 - Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer Phase 2
Active, not recruiting NCT04086875 - A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer N/A
Completed NCT00507923 - Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer N/A
Recruiting NCT06058377 - Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer Phase 3
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05455658 - STEMVAC in Patients With Early Stage Triple Negative Breast Cancer Phase 2
Recruiting NCT05674578 - Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors N/A

External Links