Gestão do Stress Cognitivo-Comportamental Remotamente Entregue para o Cancro da Mama (R-CBSM)
Efeitos da Gestão do Stress Cognitivo-Comportamental Entregue à Distância no Envelhecimento Acelerado por Cancro em Sobreviventes Idosas e Angustiadas de Cancro da Mama
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Dolores Perdomo, Ph.D
- Número de telefone: (305) 284-2220
- E-mail: Dperdomo@miami.edu
Estude backup de contato
- Nome: Dolores Perdomo
Locais de estudo
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Florida
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Coral Gables, Florida, Estados Unidos, 33146
- Recrutamento
- University of Miami
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Contato:
- Dolores Perdomo, Ph.D
- Número de telefone: (305) 284-2220
- E-mail: Dperdomo@miami.edu
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Investigador principal:
- Michael Antoni, PhD
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Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: R-CBSM+Survivorship Care Planning (SCP)
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. |
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. 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. |
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Comparador Ativo: Standard of Care Survivorship Care Planning (SCP Only)
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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
Prazo: Baseline, 6 months, 12 months
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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. |
Baseline, 6 months, 12 months
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Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function
Prazo: Baseline, 6 months, 12 months, 24 months
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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. |
Baseline, 6 months, 12 months, 24 months
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers
Prazo: Baseline, 6 months, 12 months
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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. |
Baseline, 6 months, 12 months
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Change in Mental Health measured by Composite Depression Severity
Prazo: Baseline, 6 months, 12 months, 24 months
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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. |
Baseline, 6 months, 12 months, 24 months
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Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire
Prazo: Baseline, 6 months, 12 months, 24 months
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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. |
Baseline, 6 months, 12 months, 24 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Michael Antoni, Ph.D, University of Miami
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- 20250766
- 1R01CA296071-01A1 (Concessão/Contrato do NIH dos EUA)
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