StressPhase 4VSMARTNCT03955991
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
A Phase 4 study testing R-CBSM and Influenza vaccine in people with Stress, run by University of Miami at 1 site in United States.
Trial summary
The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Stress
- What is being tested?
- R-CBSM and Influenza vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2016to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"
- No prior history of cancer (with the exception of non-melanoma skin cancer)
- Life expectancy of > 12 months.
- No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans.
- No substance dependency in the past 12 months.
- No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)
Show all 11Show fewer
- No prior neo-adjuvant therapy
- No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)
- No significant cognitive impairment, must score <31 on the Telephone Interview for Cognitive Status (TICS)49.
- At least a 6th grade reading level in English and be available for follow-up
- Women age 50 and older diagnosed with stage 0-III breast cancer.
Who cannot join
- Does not meet all Inclusion Criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.
- Conditions
- Stress
- Being tested
- R-CBSM, Influenza vaccine
- Keywords
- Breast Cancer, Flu Vaccine
- Medical subject headings
- Breast Neoplasms, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CBSMBehavioural
10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.
Influenza vaccineBiological
Standard of care Influenza vaccine for that given year.
| Study group | Role | What they receive |
|---|---|---|
| R-CBSM | Experimental | 10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine. Receives: Behavioral: R-CBSM; Biological: Influenza vaccine |
| Wait List Condition (WLC) | Active comparator | Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine. Receives: Behavioral: R-CBSM; Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination inhibition assay (HAI) - Fold response to IV
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Measured: 28 days post vaccine
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.
Measured: 28 days post vaccine
Secondary outcomes (7)
Change in Affective Status
Affective Status is comprised of the Impact of Event Score Intrusion (IES-I), Affect Balance Scale (ABS) negative affect, positive affect and Center for Epidemiologic Studies Depression (CES-D) that comprise a latent construct
Measured: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Change in Circulating Cytokine levels
Serum from blood samples will be evaluated for cytokine indices for Interleukin
(IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).
Measured: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Change in Affective Status markers
Affective status change as measured by a Latent variable that compares the effects of the 2 groups.
Measured: Baseline (T0) to 28-day post IV (T3).
Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)
Level of AID activity in B cells
Measured: Baseline (T0) to 6 months (T1).
Change in Immune Status measured by Switched B-cells (swB)
Percentage of B-cells indicator.
Measured: Baseline (T0) to 28-day post IV (T3).
Magnitude of Immune changes associated with Flu Vaccine response
Measured by a change score in sw B-Cell and AID response with change HAI response
Measured: Baseline (T0) to 28-day post IV (T3)
Magnitude of Inflammatory changes associated with Flu Vaccine response
Measured by a change score in inflammatory cytokines with change in HAI response
Measured: Baseline (T0) to 28-day post IV (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start21 Jul 2016
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Principal investigator, Michael H. Antoni, University of Miami
- Investigators
- Michael H Antoni, Ph.D, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955991
- Sponsor's protocol ID
- 20160525
- Acronym
- VSMART
- Status last verified
- Jun 2024
- First submitted
- 15 May 2019
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saez-Clarke E, Walsh EA, Lovan P, Plotke R, Ream M, Popok P, Perdomo D, Blomberg B, Antoni MH. Distress tolerance and perceived cancer-related cognitive impairment in nonmetastatic breast cancer. Health Psychol. 2025 Feb;44(2):166-170. doi: 10.1037/hea0001417. Epub 2024 Sep 23.
PubMed 39311813
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03955991
- Acronym / sponsor ID
- VSMART / 20160525
- Conditions
- Stress
- Keywords
- Breast Cancer, Flu Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 May 2019 (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 proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CBSM | Experimental | Behavioral: R-CBSM, Biological: Influenza vaccine10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine. |
| Wait List Condition (WLC) | Active comparator | Behavioral: R-CBSM, Biological: Influenza vaccinePersons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"
- No prior history of cancer (with the exception of non-melanoma skin cancer)
- Life expectancy of > 12 months.
- No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans.
- No substance dependency in the past 12 months.
Key exclusion criteria (1 listed)
- Does not meet all Inclusion Criteria.
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 |
|---|---|---|
| R-CBSM10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises. | Behavioural | R-CBSM, Wait List Condition (WLC) |
| Influenza vaccineStandard of care Influenza vaccine for that given year. | Biological | R-CBSM, Wait List Condition (WLC) |
Primary outcome
Hemagglutination inhibition assay (HAI) - Fold response to IV
Time frame: 28 days post vaccine
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
Time frame: 28 days post vaccine
Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.
7 secondary outcomes
Change in Affective Status
Time frame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Change in Circulating Cytokine levels
Time frame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Change in Affective Status markers
Time frame: Baseline (T0) to 28-day post IV (T3).
Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)
Time frame: Baseline (T0) to 6 months (T1).
Change in Immune Status measured by Switched B-cells (swB)
Time frame: Baseline (T0) to 28-day post IV (T3).
Magnitude of Immune changes associated with Flu Vaccine response
Time frame: Baseline (T0) to 28-day post IV (T3)
Magnitude of Inflammatory changes associated with Flu Vaccine response
Time frame: Baseline (T0) to 28-day post IV (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 39311813Saez-Clarke E, Walsh EA, Lovan P, Plotke R, Ream M, Popok P, Perdomo D, Blomberg B, Antoni MH. Distress tolerance and perceived cancer-related cognitive impairment in nonmetastatic breast cancer. Health Psychol. 2025 Feb;44(2):166-170. doi: 10.1037/hea0001417. Epub 2024 Sep 23.
- 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. This study is not recruiting at the moment.
Michael H 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 Phase 4 study testing R-CBSM and Influenza vaccine in people with Stress, 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 11 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemagglutination inhibition assay (HAI) - Fold response to IV (time frame: 28 days post vaccine). 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?
On the ClinicalTrials.gov record for NCT03955991, which also lists 1 linked publication.
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 26 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.