Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors

Официальное название

Evaluating Effectiveness of an Integrative Intervention Based on Physical Activity, Nutrition and Supportive Care to Improve Quality of Life of Breast Cancer Survivors: Protocol for a Pragmatic Cluster Randomized Trial and Embedded Qualitative Study

Обзор

Despite it being one of the leading causes of cancer death among women, survival following a breast cancer diagnosis has greatly increased in high-income countries. However; this gave rise to a growing population of women living long after breast cancer with a diminished quality of life (QoL) due to the long-term effects of cancer and cancer treatment. Exercise can improve QoL, fatigue, and other mental and physical health outcomes in this population, and is strongly recommended among breast cancer survivors, much like a healthy diet. However adherence in real-life to these recommendations is seldom satisfactory. Also, evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited. Hence the need to develop pragmatic (evaluating the effectiveness of interventions in real-life conditions) theoretical-based customized interventions, which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors. ADA (Activité physique adaptée Doublée d'un Accompagnement spécifique post-cancer) is an integrative intervention based on physical activity, nutrition and supportive care. The interventions aims to improve breast cancer survivors' physical and mental health and instill long-term healthy behaviors. Our study will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial which examines the effectiveness of the ADA intervention program. The primary endpoint will be health-related quality of life, as measured at 12-month after the start of the trial. Several secondary outcomes will also be assessed; which include Physical activity level, relationship to food and self-efficacy. The study aims to recruit 160 participants in total, divided into 20 activity groups (clusters) of 8 participants. Primary analyses will be carried out on an intention to treat (ITT) basis, at both cluster and participant level. All statistical analysis will adjust for the clustering of patients within centers as a random effect. The aim of this trial is to provide scientific evidence on the 'real-world' effectiveness of an easily generalizable trial, with clinically-significant outcomes, touching a growing number of cancer survivors.

Вмешательства

• Поведенческое ADA
  The 12-weeks program will include one-hour in adapted physical activity (APA), and a discussion on relaxation techniques and the undertaking of deep breathing exercises (making them APA+ sessions). A series of "minute for nutrition" short information sheets will be distributed at the end of each session. Two workshops on "living better after breast cancer" will also be offered: one on general mobility and the other on daily nutrition. Moreover, women will be asked to set personal challenges as
• Поведенческое Usual Care
  Participants in the control group will be offered weekly APA sessions for 12 weeks, these sessions are based on current practices within the Siel Bleu organization. Sessions' content is adapted to people who have been treated for (all types) cancer and are based on current recommendations. These sessions are commonly organized by Siel Bleu in hospitals, community groups or local committees of the national league against cancer organization.

Первичные конечные точки

• Health-related quality of life [Срок оценки: 12 months after the beginning of the intervention]

Вторичные конечные точки (7)

• Physical, social, emotional, and functional well-being [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]
• Fatigue [Срок оценки: At 3 months, and 6 months after the beginning of the intervention]
• Physical activity level [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]
• Motivation for physical activity Questionnaire-2 (BREQ-2) scale [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]
• Sedentary behavior (sitting time) [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]
• Relationship to food [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]
• Self-efficacy [Срок оценки: At 3 months, 6 months, and 12 months after the beginning of the intervention]

Критерии участия

Критерии включения

• adult women who are between 18 and 72 years of age
• had a diagnosis of localized breast cancer of any type, and who have completed their treatment (surgery, chemotherapy, radiotherapy) within the last 15 months, or still undergoing hormone therapy or nearing the end of their Herceptin treatment.
• French-speaking
• covered by the French Social Security system or benefiting from a similar health insurance system

Критерии исключения

• A cancer diagnosis other than breast cancer, or a relapse/metastasis of breast cancer, or generalized cancer,
• A medical contraindication to exercise (a medical certificate of absence of contraindication to the practice of physical activity will be required, as for all physical activity in community settings).
• Significant visual or auditory problems or behavioral problems that make it difficult to participate in group physical activity sessions.
• a plan of moving away from the study site.
• participating in another clinical trial
• Male sex

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 8 центров

• La Rochelle — La Rochelle
• Saint Brieuc — Saint-Brieuc
• Arpajon — Arpajon
• Brest — Brest
• Blagnac — Blagnac
• Angers — Angers
• Pyrénées Atlantiques — Saint-Pée-sur-Nivelle
• La Roche sur Yon — La Roche-sur-Yon

Публикации

• El-Khoury F, Mino JC, Deschamps N, Lopez C, Menvielle G, Dargent-Molina P. Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study. BMJ Open. 2024 Mar 14;14(3):e081447. doi: 10.1136/bmjopen-2023-081447. PMID 38485475

Идентификаторы

NCT: NCT05658341 · ADA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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