Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) | Behavioral | — | UNRESOLVED |
| Standard of Care Survivorship Care Planning | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- R-CBSM+Survivorship Care Planning (SCP)
- description
- Subjects in this group will receive 10 weeks of group R-CBSM intervention convened by a broadband connection for approximately 75 - 90 minutes at a mutually convenient time plus a standard of care survivorship care planning.
- interventionNames
- Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)
- Behavioral: Standard of Care Survivorship Care Planning
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Survivorship Care Planning (SCP Only)
- description
- Participants in this group will receive the standard of care survivorship care planning (SCP) only. Each participant will have a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have.
- interventionNames
- Behavioral: Standard of Care Survivorship Care Planning
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available