Head and Neck Cancer
Conditions
Keywords
ChemoRT, HNC, Wellness
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORAL20-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 Cancer training series led by a speech pathologist.
Sponsors
Renown Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Severe malnutrition requiring exclusive enteral feeding at baseline * Comorbidities that preclude safe participation in exercise * Cognitive or psychiatric conditions that impair study engagement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Program: Adverse Events | 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) |
| Feasibility of Program: Recruitment Rate | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Over the 20-week intervention period | Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes of Interest: Change in Sarcopenia Risk | From baseline to week 20 | Assessed using the SARC-F Questionnaire at baseline and week 20. Unit of Measure: Units on a scale (0-10) Interpretation: Higher scores indicate greater risk of sarcopenia. |
| Clinical Outcomes of Interest: Change in Depression Symptoms | From baseline to week 20 | Assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline and week 20. Unit of Measure: Units on a scale (0-27) Interpretation: Higher scores indicate more severe depressive symptoms. |
| Clinical Outcomes of Interest: Change in Anxiety Symptoms | From baseline to week 20 | Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline and week 20. Unit of Measure: Units on a scale (0-21) Interpretation: Higher scores indicate more severe anxiety symptoms. |
| Clinical Outcomes of Interest: Change in Lean Body Mass | From baseline to week 20 | Measured via bioimpedance scale at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg) |
| Clinical Outcomes of Interest: Change in Body Weight | From baseline to week 20 | Measured at baseline, bi-weekly, and week 20. Unit of Measure: Kilograms (kg) |
| Clinical Outcomes of Interest: Change in Grip Strength | From baseline to week 20 | Measured using a hand dynamometer at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg) |
| Clinical Outcomes of Interest: Change in Functional Capacity (6MWT) | From baseline to week 20 | Measured using the 6-minute walk test at baseline, week 7, and week 20. Unit of Measure: Meters walked |
| Clinical Outcomes of Interest: Quality of Life | From enrollment to the end of the intervention at 20 weeks | Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) at baseline and week 20. Unit of Measure: Units on a scale (0-100) Interpretation: Higher scores indicate better functioning or quality of life for functional scales; higher scores indicate worse symptoms for symptom scales. |
Countries
United States
Contacts
Primary ContactKristen Gurnea, MPH
Outcome results
None listed