Идёт набор NCT07160296

Supporting Treatment Resilience With Optimized Nutrition and Guided Exercise in Head and Neck Cancer Patients Undergoing Chemoradiation

Без фазы С лечением Head and Neck Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 20-Week Lifestyle Program.
Кому может быть актуально: Состояния в реестре: Head and Neck Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study to find out whether a structured lifestyle intervention-combining nutrition counseling, guided exercise, and wellness education-can help reduce treatment-related side effects and improve physical function, resilience, and quality of life in patients with head and neck cancer undergoing chemoradiation therapy (chemoRT). Benefits of research cannot be guaranteed but we hope to learn whether this intervention is feasible and acceptable during active cancer treatment, and whether it can help preserve lean body mass, improve strength and endurance, and support emotional well-being. The findings will inform the design of a future larger clinical trial.

Подробное описание

This pilot study aims to assess the feasibility and preliminary effects of a multimodal lifestyle intervention-integrating nutrition optimization, guided exercise, and wellness education-on sarcopenia and resilience during treatment for HNC. The scope of these assessments are not experimental in nature, but will be applied in combination for this patient population as supplemental care. While the interventions are not uncommon for cancer patients, particularly as cancer patients may seek these care options independently during treatment, the participants will not be billed for these services as they are experimental in that they are not in standard treatment guidelines.

This pilot study will inform the refinement of the STRONGER intervention for future use in a larger randomized controlled trial. It will test implementation logistics and provide preliminary data on intervention benefits for patients undergoing intensive cancer therapy, such as chemoRT.

Вмешательства

Поведенческое 20-Week Lifestyle Program
Nutrition counseling: Weekly group sessions with an oncology dietitian, including individualized calorie and protein goals. Exercise: Home-based resistance and mobility exercises twice per week using online videos, and daily walking with self-tracking. Wellness education: Weekly group sessions focused on stress management, sleep, fatigue, and mindset, facilitated by a health and wellness coach. Five of the 20 sessions will include a Speech, Voice, Swallowing, and Airway Care in Head \& Neck Ca

Первичные конечные точки

Feasibility of Program: Recruitment Rate [Срок оценки: From enrollment to the end of the intervention at 20 weeks]
Program Acceptability [Срок оценки: From enrollment to the end of the intervention at 20 weeks]
Feasibility of Program: Retention Rate [Срок оценки: From enrollment to 20 weeks]
Feasibility of Program: Session Attendance [Срок оценки: Over the 20-week intervention period]
Feasibility of Program: Adherence to Exercise Plan - Resistance Training [Срок оценки: Over the 20-week intervention period]
Feasibility of Program: Adherence to Exercise Plan - Walking Goals [Срок оценки: Over the 20-week intervention period]
Feasibility of Program: Data Completeness [Срок оценки: From baseline to 20-week follow-up]
Feasibility of Program: Protocol Fidelity [Срок оценки: Over the 20-week intervention period]
Feasibility of Program: Adverse Events [Срок оценки: Over the 20-week intervention period]

Вторичные конечные точки (8)

Clinical Outcomes of Interest: Quality of Life [Срок оценки: From enrollment to the end of the intervention at 20 weeks]
Clinical Outcomes of Interest: Change in Sarcopenia Risk [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Depression Symptoms [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Anxiety Symptoms [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Lean Body Mass [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Body Weight [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Grip Strength [Срок оценки: From baseline to week 20]
Clinical Outcomes of Interest: Change in Functional Capacity (6MWT) [Срок оценки: From baseline to week 20]

Критерии участия

Критерии включения

Adults ≥18 years old with biopsy-confirmed squamous cell carcinoma of the head and neck
Planned for definitive or adjuvant chemoRT
ECOG performance status 0-2
Ability to participate in light-to-moderate physical activity
Able to provide informed consent