Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
Brief Summary: Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.


Options:
A: Arm Label: multimodal intervention; Type: EXPERIMENTAL; Interventions: Other: standard care, Other: nutritional supplements and advice, Other: home-based self-assisted exercise program, Drug: Ibuprofen | Arm Label: standard care; Type: ACTIVE_COMPARATOR; Interventions: Other: standard care | Intervention Type: OTHER; Name: standard care; Assigned to Arm(s): multimodal intervention, standard care | Intervention Type: OTHER; Name: nutritional supplements and advice; Assigned to Arm(s): multimodal intervention | Intervention Type: OTHER; Name: home-based self-assisted exercise program; Assigned to Arm(s): multimodal intervention | Intervention Type: DRUG; Name: Ibuprofen; Assigned to Arm(s): multimodal intervention
B: Arm Label: Exercise; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physical exercise, Other: best supportive care | Arm Label: No exercise; Type: OTHER; Interventions: Other: best supportive care | Intervention Type: BEHAVIORAL; Name: Physical exercise; Assigned to Arm(s): Exercise | Intervention Type: OTHER; Name: best supportive care; Assigned to Arm(s): Exercise, No exercise
C: Arm Label: Training Group; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Training Group
D: Arm Label: Immediate Lifestyle Intervention - Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention, Behavioral: Maintenance Intervention | Arm Label: Immediate Lifestyle Intervention - No Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Arm Label: Delayed Lifestyle Intervention - Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention, Behavioral: Maintenance Intervention | Arm Label: Delayed Lifestyle Intervention - No Maintenance Program; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Intervention Type: BEHAVIORAL; Name: Lifestyle Intervention; Assigned to Arm(s): Delayed Lifestyle Intervention - Maintenance Program, Delayed Lifestyle Intervention - No Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - No Maintenance Program | Intervention Type: BEHAVIORAL; Name: Maintenance Intervention; Assigned to Arm(s): Delayed Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program

Answer: D