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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CBSM | Experimental | 10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine. |
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| Wait List Condition (WLC) | Active Comparator | Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CBSM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition assay (HAI) - Fold response to IV | As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine | 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. | 28 days post vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Antoni, Ph.D | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flipse Building | Coral Gables | Florida | 33124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39311813 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Influenza vaccine | Biological | Standard of care Influenza vaccine for that given year. |
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| 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). | 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. | 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 | Baseline (T0) to 6 months (T1). |
| Change in Immune Status measured by Switched B-cells (swB) | Percentage of B-cells indicator. | 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 | 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 | Baseline (T0) to 28-day post IV (T3) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |