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Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support."
  • "PRIMARY OBJECTIVES: I Acceptability of the biobehavioral intervention will be determined using the Client Satisfaction Questionnaire (CSQ)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adults with newly diagnosed, untreated stage I–III triple negative breast cancer can finish a 10-week stress reduction program. The program teaches ways to relax, cope, solve problems, and get support, and offers social work referrals for needs like transportation or utility bills. Researchers will measure stress through patient reports and signs in the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Newly diagnosed triple negative breast cancer that has not been treated.
  • Stage I, II, or III breast cancer (stages 1–3).

Who can't join

  • People in prison.
  • Males.
  • People who identify as American Indian, Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.
  • People who cannot speak and understand English.
  • A known past history of DCIS (cancer inside the breast’s milk ducts) or invasive breast cancer (cancer that has grown into nearby breast tissue).
  • Stage IV (stage 4) breast cancer, which has spread to distant parts of the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

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