Breast CancerNCT07502352
Remotely-Delivered Cognitive Behavioral Stress Management for Breast Cancer (R-CBSM)
A study testing Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dolores Perdomo contact
United States1 site, 1 recruiting
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Dolores Perdomo, Ph.D, (305) 284-2220, Dperdomo@miami.edu
Michael Antoni, PhD
About this study
Official title: Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors
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
- Breast Cancer
- Being tested
- Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM), Standard of Care Survivorship Care Planning
- Keywords
- Breast Cancer Survivors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)Behavioural
Participants will receive the remotely delivered "telehealth" Cognitive Behavioral Stress Management (CBSM) intervention, consisting of 10 weeks of structured group sessions. The program will include core CBSM components such as cognitive restructuring, relaxation training, coping skills development, and strategies for managing stress-related thoughts and behaviors. Sessions will be conducted via a secure broadband connection and will last approximately 75-90 minutes, scheduled at a mutually convenient time for group members. Prior to beginning the intervention, each participant will complete a 30-minute individual orientation call. This session will provide instructions on how to join and participate in the group meetings remotely using videoconferencing on a handheld device, laptop, desktop computer, or mobile phone. The orientation will also familiarize participants with the technology, group procedures, and expectations to ensure smooth engagement throughout the program.
Standard of Care Survivorship Care PlanningBehavioural
Participants will receive the Standard of Care Survivorship Care Planning that includes a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have. The SCP being used in the proposed study will use a prospective preparation of the treatment summary and care plan. The SCP is designed to facilitate access to resources provided by our cancer center's survivorship program (e.g., nutritional, exercise physiology, music therapists, acupuncture) which we will monitor for use. The SCP is based on templates for breast cancer survivorship employed at the Sylvester Comprehensive Cancer Center (SCCC) Breast Survivorship Program and includes access to cancer survivorship resources, which is the standard of care control condition.
| Study group | Role | What they receive |
|---|---|---|
| R-CBSM+Survivorship Care Planning (SCP) | Experimental | 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. Receives: Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM); Behavioral: Standard of Care Survivorship Care Planning |
| Standard of Care Survivorship Care Planning (SCP Only) | Active comparator | 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. Receives: Behavioral: Standard of Care Survivorship Care Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
Cancer-specific intrusive distress will be measured using the 7-item Intrusion subscale of the Impact of Event Scale (IES). Each item is scored 0 ("not at all"), 1 ("rarely"), 3 ("sometimes"), or 5 ("often"), yielding a total score range of 0-35. Scores reflect the frequency of intrusive, cancer-related thoughts over the past 7 days. Higher scores indicate greater intrusive distress, and lower scores indicate fewer intrusive thoughts and better psychological adaptation. Change scores will be calculated as slope of change over 3 time points (baseline, 6months, and 12 months). Negative slops indicate improvement (reduced intrusive distress), and positive values indicate worsening. Change scores (slopes) will be compared between the R-CBSM+SCP and SCP-only arms to evaluate whether the combined intervention produces greater improvement over 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function
Change in immune cell senescence will be measured using latent construct composite of B- and T-lymphocyte metabolic indicators (ATP production, maximum respiration, and spare respiratory capacity). A composite score will be created from ATP production, maximum respiration, and spare respiratory capacity to index lymphocyte hyper-metabolism, a marker of cancer-accelerated aging. Higher composite values indicate greater immune senescence. Composite change scores (slope of change over the 4 time points) will be compared between study arms, R-CBSM+SCP and SCP only, over 6- and 12-months Increases indicate worsening immune senescence while decrease indicate lessening immune senescence.
Measured: Baseline, 6 months, 12 months, 24 months
Secondary outcomes (3)
Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers
Change in neuroendocrine regulation assessed using a latent construct composite of 24-hour salivary cortisol area-under-the-curve (AUC), 24-hour salivary cortisol diurnal slope, and 4-day average heart rate variability (HRV). A standardized composite score will be created from cortisol AUC, cortisol diurnal slope, and 4-day average HRV to index neuroendocrine stress regulation. Increases in any of these indicators is associated with increased stress and greater neuroendocrine dysregulation. Change scores (slope of change over the 3 time points) will be compared between study arms. Increases in slope indicate worsening neuroendocrine dysregulation/stress while slope decreases indicate lessening neuroendocrine dysregulation/stress.
Measured: Baseline, 6 months, 12 months
Change in Mental Health measured by Composite Depression Severity
Change in depression severity will be measured using a latent construct composite of self-report and clinician-rated measures of depression: the Center for Epidemiologic Studies Depression Scale (CES-D), the Hamilton Rating Scale for Depression (HRSD), and depressive diagnoses from the Structured Clinical Interview for DSM-5 (SCID-5). A standardized composite score (e.g. Z score) will be created from CES-D total scores, HRSD clinician-rated severity scores, and SCID-5 depressive episode diagnoses to index overall depression severity. Higher composite values indicate greater depressive symptom burden. Change scores (slope of change over the 4 time points) will be compared between study arms. Increases over time indicate worsening depression while decreases indicate lowering of depression over time.
Measured: Baseline, 6 months, 12 months, 24 months
Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire
Change in quality of life will be measured using the patient-reported Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Quality of life will be measured using the FACT-B, a validated self-report questionnaire assessing physical, social, emotional, functional well-being, and breast cancer-specific concerns. Higher total scores indicate better quality of life. Score Range is 0-148 (higher scores reflect better quality of life). Change scores in total quality of life (slope of change over the 4 time points) will be compared between study arms. Therefore, increases in the slope indicate increasing quality of life while decreases indicate worsening quality of life over time.
Measured: Baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start10 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael H. Antoni, University of Miami
- Investigators
- Michael Antoni, Ph.D, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502352
- Sponsor's protocol ID
- 20250766
- Other IDs
- 1R01CA296071-01A1
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07502352
- Acronym / sponsor ID
- 20250766
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CBSM+Survivorship Care Planning (SCP) | Experimental | Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM), Behavioral: Standard of Care Survivorship Care PlanningSubjects 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. |
| Standard of Care Survivorship Care Planning (SCP Only) | Active comparator | Behavioral: Standard of Care Survivorship Care PlanningParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)Participants will receive the remotely delivered "telehealth" Cognitive Behavioral Stress Management (CBSM) intervention, consisting of 10 weeks of structured group sessions. The program will include core CBSM components such as cognitive restructuring, relaxation training, coping skills development, and strategies for managing stress-related thoughts and behaviors. Sessions will be conducted via a secure broadband connection and will last approximately 75-90 minutes, scheduled at a mutually convenient time for group members. Prior to beginning the intervention, each participant will complete a 30-minute individual orientation call. This session will provide instructions on how to join and participate in the group meetings remotely using videoconferencing on a handheld device, laptop, desktop computer, or mobile phone. The orientation will also familiarize participants with the technology, group procedures, and expectations to ensure smooth engagement throughout the program. | Behavioural | R-CBSM+Survivorship Care Planning (SCP) |
| Standard of Care Survivorship Care PlanningParticipants will receive the Standard of Care Survivorship Care Planning that includes a 30-minute orientation call to provide them with information on Survivorship Care Planning (SCP) and answer any questions they may have. The SCP being used in the proposed study will use a prospective preparation of the treatment summary and care plan. The SCP is designed to facilitate access to resources provided by our cancer center's survivorship program (e.g., nutritional, exercise physiology, music therapists, acupuncture) which we will monitor for use. The SCP is based on templates for breast cancer survivorship employed at the Sylvester Comprehensive Cancer Center (SCCC) Breast Survivorship Program and includes access to cancer survivorship resources, which is the standard of care control condition. | Behavioural | R-CBSM+Survivorship Care Planning (SCP), Standard of Care Survivorship Care Planning (SCP Only) |
Primary outcome
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
Time frame: Baseline, 6 months, 12 months
Cancer-specific intrusive distress will be measured using the 7-item Intrusion subscale of the Impact of Event Scale (IES). Each item is scored 0 ("not at all"), 1 ("rarely"), 3 ("sometimes"), or 5 ("often"), yielding a total score range of 0-35. Scores reflect the frequency of intrusive, cancer-related thoughts over the past 7 days. Higher scores indicate greater intrusive distress, and lower scores indicate fewer intrusive thoughts and better psychological adaptation. Change scores will be calculated as slope of change over 3 time points (baseline, 6months, and 12 months). Negative slops indicate improvement (reduced intrusive distress), and positive values indicate worsening. Change scores (slopes) will be compared between the R-CBSM+SCP and SCP-only arms to evaluate whether the combined intervention produces greater improvement over 6 and 12 months.
Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function
Time frame: Baseline, 6 months, 12 months, 24 months
Change in immune cell senescence will be measured using latent construct composite of B- and T-lymphocyte metabolic indicators (ATP production, maximum respiration, and spare respiratory capacity). A composite score will be created from ATP production, maximum respiration, and spare respiratory capacity to index lymphocyte hyper-metabolism, a marker of cancer-accelerated aging. Higher composite values indicate greater immune senescence. Composite change scores (slope of change over the 4 time points) will be compared between study arms, R-CBSM+SCP and SCP only, over 6- and 12-months Increases indicate worsening immune senescence while decrease indicate lessening immune senescence.
3 secondary outcomes
Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers
Time frame: Baseline, 6 months, 12 months
Change in Mental Health measured by Composite Depression Severity
Time frame: Baseline, 6 months, 12 months, 24 months
Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire
Time frame: Baseline, 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dolores Perdomo contact
Michael Antoni, Ph.D principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM) in people with Breast Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dolores Perdomo, Ph.D ((305) 284-2220, Dperdomo@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion) (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.