This study is for patients that have been diagnosed with head and neck cancer. The purpose of this study is to examine whether HN-STAR can help healthcare providers care for survivors of head and neck cancer.
Because head and neck cancer arises in cosmetically and functionally critical areas, head and neck cancer survivors suffer high rates of body image-related distress. Body image-related distress is a source of significant morbidity, contributing to stigmatization, social isolation, and worse quality of life. Unfortunately, effective therapies exist to manage body image-related distress among head and neck cancer survivors are lacking. We have developed a novel, scalable, tele-cognitive behavioral therapy intervention for head and neck cancer survivors with body image disturbance that could provide the first effective treatment in this population, thereby minimizing psychosocial morbidity, improving quality of life, and developing new standards of clinical care.
For patients with head and neck cancer, delays starting adjuvant radiation therapy are common, disproportionately burden racial minorities, and contribute to poor survival and racial disparities in mortality. However, effective therapies to improve the delivery of timely, equitable, guideline-adherent adjuvant radiation therapy are lacking. We have developed a navigation-based multilevel intervention to enhance care coordination, communication, and key cancer care delivery processes that could provide the first effective treatment in this population, thereby improving survival, decreasing racial disparities in outcomes, and developing new standards of clinical care.
This phase II/III study purpose is to see if neck and shoulder function and pain are better after sentinel lymph node (SLN) biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. If decided to participate in this study participants will go through a pre-treatment period to determine if they are eligible for the study including a PET/CT scan to determine if their cancer has spread. They will also receive a quality of life questionnaire to determine their physical well-being. Participants will complete these questionnaires 5 times: before surgery; at 3 weeks after surgery; and at 3, 6 and 12 months after surgery. If their cancer has not spread participants will be randomized to receive SLN or the SOC Elective Neck Dissection (END) to remove their cancer/lymph nodes during the treatment period. Following treatment, participants will enter the follow-up period and the study doctor will continue to follow participates condition and watch for side effects of the surgery. Participants will visit in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for their lifetime. The study duration for the phase II portion is about 37 months (~3.1 years) and around 132 months (11 years) for the phase III portion. The main risk associated with this study are leakage of lymph fluid called "chyle" into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.