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Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)

Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors

Who can join

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

Age
50 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

  • Procedures mentioned: Phone or video check-ins

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
  • "This is a group stress management program done from home using technology, like Zoom to conduct video calls to conduct group-based training in stress management techniques (e.g., relaxation, cognitive behavioral therapy, coping skills training) in a supportive environment."
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 an at-home group program can help women manage stress after breast cancer treatment. Women learn relaxation and coping skills through video calls, such as Zoom. It is for women age 50 or older who have finished their main breast cancer treatment and are taking hormone treatment.

The purpose of this research study to find out if a program called Remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) can help women with breast cancer in the period of survivorship after they have completed treatment. This is a group stress management program done from home using technology, like Zoom to conduct video calls to conduct group-based training in stress management techniques (e.g., relaxation, cognitive behavioral therapy, coping skills training) in a supportive environment. It is for women aged 50 or older who have finished their main breast cancer treatments (like surgery, radiation, or chemo) and are undergoing hormone treatment. This study is important because many breast cancer survivors still feel stress, even after treatment ends. Teaching stress management may help the body and mind work better and may slow down the effects of aging caused by cancer and stress.

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

Eligibility

Who can join

  • Are a woman age 50 or older.
  • Speak and read English or Spanish at a 6th-grade level.
  • Had stage I–III breast cancer that responds to estrogen or progesterone hormones and is HER2-negative (does not have high levels of the HER2 protein).
  • Finished main breast cancer treatment 3–12 months ago. You may or may not have had chemotherapy or radiation.
  • Have gone more than 12 months without a period.
  • Have high stress, based on a study test or the lead researcher's review.
  • If taking medicine for depression or anxiety, have been on a similar treatment plan for more than 2 months.
  • Are taking hormone treatment after your main cancer treatment.

Who can't join

  • Cannot or do not want to give informed consent (agree to join after learning about the study).
  • Have breast cancer that has spread to distant parts of the body, is HER2-positive, or is triple-negative.
  • Had another cancer in the 2 years before this breast cancer diagnosis, except non-melanoma skin cancer.
  • Have an active, untreated major mental illness, such as schizophrenia, psychosis, bipolar disorder, substance abuse, panic disorder, or PTSD.
  • Have another health condition known to affect the immune system, such as HIV, lupus, rheumatoid arthritis, hepatitis, multiple sclerosis, Graves' disease, chronic fatigue syndrome, or fibromyalgia. A history of heart disease, stroke, heart attack, or heart failure does not rule you out.
  • Have major trouble with memory or thinking, shown by a score below 32 on the study's phone test.
  • Received immunotherapy (treatment that uses the immune system) as part of cancer treatment.

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

Official eligibility criteria

Inclusion Criteria: * 50 yrs or older * Speaks and reads English or Spanish at 6th grade level * Diagnosed and completed primary treatment for Stage I-III HR + estrogen/ progesterone + (ER/PR) * Human Epidermal Growth Factor Receptor 2 (Her2neu)- breast cancer 3 - 12 months prior * Post-menopausal (\> 12 months since last menstrual cycle) * Elevated distress (Impact of Event Scale-intrusive thoughts \[IES-I\] \> 14 or elevated distress based on assessment of PI * If prescribed anti-depressants or anxiolytics on similar regimen \> 2 months. * Undergoing treatment with Adjuvant Endocrine Therapy (AET) * Participants may or may not have received chemotherapy or radiation during primary treatment Exclusion Criteria: * Unable or unwilling to provide informed consent * Diagnosis with metastatic disease, HER2neu+ or Triple Negative breast cancer * Prior cancer diagnosis (with the exception of non-melanoma skin cancer) in the 2 years prior to the current breast cancer diagnosis * Active untreated major mental illness (e.g., schizophrenia, psychosis, bi-polar, substance abuse, panic disorder, PTSD diagnosis), * Acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases such as Lupus, Rheumatoid Arthritis, Acute or Chronic Hepatitis, and Multiple Sclerosis, Graves' Disease, Chronic Fatigue Syndrome, Fibromyalgia etc.). example: history of heart disease, e.g., past stroke, myocardial infarction (MI), or congestive heart failure are not exclusionary. * Significant cognitive impairment, \<32 on the Telephone Interview for Cognitive Status (TICS) * Receipt of immunotherapy as part of treatment

Study sites (1)

FL