Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Arm | Experimental | Participate in a 20-week lifestyle program that includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-Week Lifestyle Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Program: Recruitment Rate | Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached. | From enrollment to the end of the intervention at 20 weeks |
| Program Acceptability | A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention | From enrollment to the end of the intervention at 20 weeks |
| Feasibility of Program: Retention Rate | Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program | From enrollment to 20 weeks |
| Feasibility of Program: Session Attendance | Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended) | Over the 20-week intervention period |
| Feasibility of Program: Adherence to Exercise Plan - Resistance Training | Percentage of prescribed resistance training sessions (2x/week) completed by each participant. Unit of Measure: Percentage (%) completion rate | Over the 20-week intervention period |
| Feasibility of Program: Adherence to Exercise Plan - Walking Goals | Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals | Over the 20-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes of Interest: Quality of Life | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen Gurnea, MPH | Contact | 17759823646 | Renown-CRD@renown.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renown Regional Medical Center | Recruiting | Reno | Nevada | 89502 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Feasibility of Program: Data Completeness | Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up. Unit of Measure: Percentage (%) complete data | From baseline to 20-week follow-up |
| Feasibility of Program: Protocol Fidelity | Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered | Over the 20-week intervention period |
| Feasibility of Program: Adverse Events | Number of safety issues reported by staff or participants during the intervention. Unit of Measure: Count (number of adverse events) | Over the 20-week intervention period |
| From enrollment to the end of the intervention at 20 weeks |
| Clinical Outcomes of Interest: Change in Sarcopenia Risk | 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. | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Depression Symptoms | 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. | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Anxiety Symptoms | 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. | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Lean Body Mass | Measured via bioimpedance scale at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg) | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Body Weight | Measured at baseline, bi-weekly, and week 20. Unit of Measure: Kilograms (kg) | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Grip Strength | Measured using a hand dynamometer at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg) | From baseline to week 20 |
| Clinical Outcomes of Interest: Change in Functional Capacity (6MWT) | Measured using the 6-minute walk test at baseline, week 7, and week 20. Unit of Measure: Meters walked | From baseline to week 20 |
| Conrad Breast Center at South Meadows | Recruiting | Reno | Nevada | 89521 | United States |
|