Multimodal Exercise and Education Program in Metastatic Breast CancerMostrar más líneas (MBC_MME)
Effects of a Multimodal Community-based Intervention Combining Physical Exercise and Health Education Workshops on Quality of Life in Women With Metastatic Breast Cancer: a Longitudinal Pre-post Study.
調査の概要
状態
詳細な説明
Women with metastatic breast cancer receiving active systemic treatment frequently experience impaired health-related quality of life, cancer-related fatigue, and limitations in daily functioning. Supportive care strategies that combine physical exercise, education, and symptom self-management may help improve these outcomes, although evidence in women living with metastatic breast cancer remains limited.
This study is a longitudinal pre-post intervention study conducted in women with metastatic breast cancer receiving active systemic treatment. Eligible participants are women with metastatic breast cancer, preserved functional status, and the ability to ambulate independently. Participants are assessed at baseline and after completion of the intervention.
The intervention lasts 12 weeks and consists of a community-based multimodal program combining supervised physical exercise and health education. The exercise component includes two 60-minute supervised sessions per week: one session of Nordic walking and one session of Tai Chi. Nordic walking sessions are supervised by a physiotherapist, and Tai Chi sessions are led by a trained instructor. Exercise sessions are adapted to participants' physical capacity and clinical condition.
In addition to the exercise component, participants attend structured health education workshops throughout the program. These sessions address topics relevant to women with metastatic breast cancer, including general aspects of metastatic breast cancer, systemic treatments and toxicity management, the benefits of physical exercise, nutrition and supplementation, sleep hygiene, emotional regulation, communication with the social environment, and aesthetic care during cancer treatment.
Health-related quality of life is assessed using the EORTC QLQ-C30 and the breast cancer-specific EORTC QLQ-BR45 questionnaires. Cancer-related fatigue is assessed using the EORTC QLQ-FA12 questionnaire. The study evaluates changes in global health status, functional domains, fatigue dimensions, and selected breast cancer-specific symptom and functional domains before and after the intervention.
The aim of the study is to determine whether a supervised, community-based multimodal program combining physical exercise and health education is associated with improvements in quality of life, functioning, and fatigue-related outcomes in women with metastatic breast cancer receiving active systemic treatment.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Valencia、スペイン、46010
- Carmen García Gomariz
-
-
参加基準
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
説明
Inclusion Criteria:
- Women diagnosed with metastatic breast cancer.
- Receiving active systemic treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Able to ambulate independently.
- Able and willing to participate in the multimodal intervention program.
- Provided written informed consent.
Exclusion Criteria:
- Moderate or severe cognitive impairment.
- Severe psychiatric illness.
- Sensory impairment preventing participation in the intervention or assessments.
- Chronic disabling conditions limiting participation in the planned activities.
- Unstable bone metastases, according to medical judgment, associated with risk of fragility fracture.
- Cardiac or respiratory disease limiting the capacity to perform physical activity.
- Any other medical condition that, in the opinion of the treating oncologist, contraindicated participation in the program.
研究計画
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Multimodal Exercise and Health Education Program
Participants receive a 12-week community-based multimodal intervention combining supervised physical exercise and health education.
The exercise component includes one weekly Nordic walking session and one weekly Tai Chi session, each lasting 60 minutes.
In addition, participants attend structured health education workshops addressing topics related to metastatic breast cancer, systemic treatment and toxicity management, physical exercise, nutrition, sleep hygiene, emotional regulation, communication, and aesthetic care during cancer treatment.
|
Participants receive a 12-week community-based multimodal oncology intervention combining supervised physical exercise and health education.
The exercise component consists of one weekly Nordic walking session and one weekly Tai Chi session, each lasting 60 minutes.
In addition, participants attend structured health education workshops covering metastatic breast cancer, systemic treatment and toxicity management, safe physical exercise, nutrition, sleep hygiene, emotional regulation, communication, and aesthetic care during cancer treatment.
The intervention aims to promote physical and emotional well-being, support self-management, and improve quality of life.
|
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 Global Health Status/Quality of LifeMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in global health status/quality of life assessed using the EORTC QLQ-C30 global health status scale.
Scores are transformed to a 0-100 scale, with higher scores indicating better global health status and quality of life.Mostrar más líneas
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Physical FunctioningMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in physical functioning assessed using the EORTC QLQ-C30 physical functioning scale.
Scores are transformed to a 0-100 scale, with higher scores indicating better physical functioning.Mostrar más líneas
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
|
Change in Role FunctioningMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in role functioning assessed using the EORTC QLQ-C30 role functioning scale.
Scores are transformed to a 0-100 scale, with higher scores indicating better role functioning.Mostrar más líneas
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
|
Change in Emotional FunctioningMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in emotional functioning assessed using the EORTC QLQ-C30 emotional functioning scale.
Scores are transformed to a 0-100 scale, with higher scores indicating better emotional functioning.
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
|
Change in Cancer-Related FatigueMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in fatigue assessed using the fatigue symptom scale of the EORTC QLQ-C30.
Scores are transformed to a 0-100 scale, with higher scores indicating greater fatigue symptom burden.Mostrar más líneas
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
|
Change in Multidimensional FatigueMostrar más líneas
時間枠：Baseline and after completion of the 12-week intervention
|
Change in multidimensional cancer-related fatigue assessed using the EORTC QLQ-FA12 questionnaire, including physical fatigue, emotional fatigue, cognitive fatigue, interference with daily life, and social dimension.
Scores are transformed to a 0-100 scale, with higher scores indicating greater fatigue or impairment.Mostrar más líneas
|
Baseline and after completion of the 12-week intervention
|
|
Change in Breast Cancer-Specific Quality of LifeMostrar más líneas
時間枠：Baseline and after completion of the 12-week interventionMostrar más líneas
|
Change in breast cancer-specific quality of life assessed using selected domains of the EORTC QLQ-BR45 questionnaire, including body image, future perspective, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, and skin and mucosal symptoms.
Scores are transformed to a 0-100 scale.
Higher scores indicate better functioning in functional scales and greater symptom burden in symptom scales.Mostrar más líneas
|
Baseline and after completion of the 12-week interventionMostrar más líneas
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sergio Pascual-Solaz、a. Departament of Medical Oncology, Consorcio Hospital Provincial, Castellón 12005 Valencia, Spain
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MBC_MME01
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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。