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Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy (STRIDE)

2026年8月7日 更新者：Jamie Jacobs、Massachusetts General Hospital

STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are associated with poorer quality of life (QOL) and higher anxiety. There is a critical need to increase patients' ability to cope with AET side effects and reduce adherence barriers to AET. This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, a telehealth evidence-based behavioral intervention, compared to Usual Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence.

研究の種類

介入

入学 (推定)

400

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

研究場所

  • アメリカ
    • Florida
      • Tampa、Florida、アメリカ、33612
        • Moffitt Cancer Center
        • 主任研究者：
          • Laura Oswald, PhD
        • コンタクト：
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital
        • 主任研究者：
          • Jamie M Jacobs, PhD
        • コンタクト：

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Female ≥ 21 years old
  • Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer
  • Completed primary treatment (surgery, chemotherapy, and/or radiation)
  • Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Ability to read and respond in English or Spanish
  • Distress about AET ≥ 4 on a 0-10 scale

Exclusion Criteria:

  • Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist
  • Enrolled in a clinical trial for AET

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：STRIDE Intervention
Participants randomized to STRIDE will receive a brief, manualized, videoconference intervention with six weekly one-hour sessions in small groups of two to three patients and two individual semi-structured telephone check-ins. Participants will complete questionnaires at baseline, and 3, 6, and 12 months post-baseline.
行動：STRIDE
STRIDE is a 6-session patient-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that targets coping with and managing AET side effects. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
アクティブコンパレータ：Usual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions. Participants will also complete questionnaires at baseline, and 3, 6, and 12 months post-baseline. Participants will be offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire.
行動：Usual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions.

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
Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
時間枠：Up to 12 months post-baseline
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
Up to 12 months post-baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).
時間枠：Up to 12 months post-baseline
Investigators will assess changes in adherence to treatment via the Medication Adherence Report Scale (MARS-5). The MARS-5 is a 5-tem survey used to measure AET adherence and suboptimal adherence behaviors. The scale consists of five items that are answered on a scale of 1-5, with higher scores indicating greater adherence to the medication.
Up to 12 months post-baseline
Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).
時間枠：Up to 12 months post-baseline
Participants will store medication in the Medication Event Monitoring System (MEMS Caps) bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the study period between groups.
Up to 12 months post-baseline

その他の成果指標

結果測定
メジャーの説明
時間枠
Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).
時間枠：Up to 12 months post-baseline
Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms.
Up to 12 months post-baseline
Breast cancer symptom distress as measured by the Breast Cancer Prevention Trial Checklist (BCPT).
時間枠：Up to 12 months post-baseline
The investigators will examine changes in self-reported symptom distress using the Breast Cancer Prevention Trial Checklist (BCPT). The BCPT is a symptom checklist used to document physical and psychological symptoms associated with endocrine therapy use. The measure includes several clinically relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.
Up to 12 months post-baseline
Quality of Life as measured by the Functional Assessment of Cancer Therapy (FACT-B).
時間枠：Up to 12 months post-baseline.
Investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life.
Up to 12 months post-baseline.

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

Massachusetts General Hospital

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Jamie M Jacobs, PhD、Massachusetts General Hospital

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 (推定)

2027年2月1日

一次修了 (推定)

2030年1月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年8月7日

QC基準を満たした最初の提出物

2026年8月7日

最初の投稿 (実際)

2026年8月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月12日

QC基準を満たした最後の更新が送信されました

2026年8月7日

最終確認日

2026年7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

  • 26-343
  • 1R01CA316494-01 (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?

はい

IPD プランの説明

The Harvard Cancer Consortium (HCC) encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Jamie M. Jacobs. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD 共有時間枠

Data can be shared no earlier than 1 year following the date of publication

IPD 共有アクセス基準

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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