Supporting Treatment Resilience With Optimized Nutrition and Guided Exercise in Head and Neck Cancer Patients Undergoing Chemoradiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Feasibility of Program: Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe malnutrition requiring exclusive enteral feeding at baseline
- •Comorbidities that preclude safe participation in exercise
- •Cognitive or psychiatric conditions that impair study engagement
结局指标
主要结局
Feasibility of Program: Recruitment Rate
时间窗: From enrollment to the end of the intervention at 20 weeks
Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached.
Program Acceptability
时间窗: From enrollment to the end of the intervention at 20 weeks
A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention
Feasibility of Program: Retention Rate
时间窗: From enrollment to 20 weeks
Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program
Feasibility of Program: Session Attendance
时间窗: Over the 20-week intervention period
Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)
Feasibility of Program: Adherence to Exercise Plan - Resistance Training
时间窗: Over the 20-week intervention period
Percentage of prescribed resistance training sessions (2x/week) completed by each participant. Unit of Measure: Percentage (%) completion rate
Feasibility of Program: Adherence to Exercise Plan - Walking Goals
时间窗: Over the 20-week intervention period
Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals
Feasibility of Program: Data Completeness
时间窗: From baseline to 20-week follow-up
Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up. Unit of Measure: Percentage (%) complete data
Feasibility of Program: Protocol Fidelity
时间窗: Over the 20-week intervention period
Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered
Feasibility of Program: Adverse Events
时间窗: Over the 20-week intervention period
Number of safety issues reported by staff or participants during the intervention. Unit of Measure: Count (number of adverse events)
次要结局
- Clinical Outcomes of Interest: Quality of Life(From enrollment to the end of the intervention at 20 weeks)
- Clinical Outcomes of Interest: Change in Sarcopenia Risk(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Depression Symptoms(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Anxiety Symptoms(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Lean Body Mass(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Body Weight(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Grip Strength(From baseline to week 20)
- Clinical Outcomes of Interest: Change in Functional Capacity (6MWT)(From baseline to week 20)