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遠隔認知行動ストレス管理乳がんプログラム(R-CBSM)

2026年9月18日 更新者:Michael H. Antoni、University of Miami

遠隔で提供される認知行動ストレス管理が、高齢の苦痛を抱える乳がん生存者のがん関連加速老化に及ぼす影響

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

192

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Dolores Perdomo, Ph.D
  • 電話番号:(305) 284-2220
  • メール:Dperdomo@miami.edu

研究連絡先のバックアップ

  • 名前:Dolores Perdomo

研究場所

    • Florida
      • Coral Gables、Florida、アメリカ、33146
        • 募集
        • University of Miami
        • コンタクト:
        • 主任研究者:
          • Michael Antoni, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Psychological Adaptation measured by Cancer-Specific Distress (IES-Intrusion)
時間枠: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.

Baseline, 6 months, 12 months
Change in Immune Cell Senescence measured by Lymphocyte Metabolic Function
時間枠: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.

Baseline, 6 months, 12 months, 24 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Neuroendocrine Regulation measured by Composite Stress Biomarkers
時間枠:Baseline, 6 months, 12 months

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
Change in Mental Health measured by Composite Depression Severity
時間枠:Baseline, 6 months, 12 months, 24 months

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
Change in Quality of Life measured by Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire
時間枠:Baseline, 6 months, 12 months, 24 months

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Michael Antoni, Ph.D、University of Miami

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年8月10日

一次修了 (推定)

2029年8月1日

研究の完了 (推定)

2029年8月1日

試験登録日

最初に提出

2026年3月25日

QC基準を満たした最初の提出物

2026年3月25日

最初の投稿 (実際)

2026年3月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 20250766
  • 1R01CA296071-01A1 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。