Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative… (NCT05677802) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer
United States40 participantsStarted 2022-12-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant Satisfaction with the Biobehavioral Intervention
Timeframe: Up to 2 years
2
Profile of Mood States for the Biobehavioral Intervention
Timeframe: Up to 2 years
3
Participant Biobehavioral Intervention
Timeframe: Up to 2 years
Trial details
NCT IDNCT05677802
SponsorOhio State University Comprehensive Cancer Center