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Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life (VITALS trial)
Multidisciplinary clinic (MDC) care is the standard for Amyotrophic Lateral Sclerosis (ALS) and is associated with better symptom control, quality of life, and longer survival. Patients with ALS and their caregivers attend MDC visits every 3 months and spend 4-5 hours meeting with multiple healthcare providers. Each provider gives recommendations that are important for the patient to remember and implement on their own at home. But sometimes it can be a lot to take in. The purpose of this study is to evaluate two ways to provide MDC visit information to people with ALS: video recordings plus written visit notes (new method being explored) or written visit notes alone (current method). This study examines whether providing video recordings of the clinic visits can help patients with ALS and the people who care for them.
WHO CAN TAKE PART IN THIS STUDY? People with Amyotrophic Lateral Sclerosis (ALS) who are cognitively able to consent, anticipate attending multidisciplinary clinic (MDC) visits for 12 or more months, and who have a non-professional caregiver who is also willing to take part in the study. WHAT WILL PARTICIPANTS BE ASKED TO DO? Study participants will be randomly assigned by a computer to either the NOTES Group or the VIDEO Group. All participants will be asked to review their visit notes on their online Penn State “My Health” patient portal account. All participants will be asked to complete 4 short surveys over 12 months, first at the index multidisciplinary clinic (MDC) visit before assigned to a group, then again at 1 month, 6 months, and 12 months after the index MDC visit. Surveys may be done online or on paper at home or in the clinic and participants will be compensated for completing them. The VIDEO Group participants will be videorecorded at all of their planned MDC visits for 12 months and asked to watch the video recordings after their visits on a secure mobile and online application. Patients can watch these private videos at any time or share them with someone else.
Up to a maximum possible total of $200
Plan to attend MDC visits for 12 months
Presence of a non-professional caregiver who is also participating in the VITALS trial
Projected life expectancy of at least 12 months as determined by the site investigator
Speak English or Spanish
Do not wish to create a patient portal account, if they do not already have one
Unable to access the internet
Do not have access to a personal or shared email and are not interested in creating a personal or shared email
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness as determined by the site PI
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
The purpose of this study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) are already used together to treat recurrent/metastatic head and neck squamous cell carcinoma.
Participants must come to all study visits, take the medication as instructed, tell the study how you are feeling and tell the study team about any medications you are taking, especially over the counter medications.
130.00 per completed visit
Have an ECOG performance status of 0 or 1.
Have histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies.
Be treatment-naïve for systemic therapy in the R/M setting.
Have measurable disease according to RECIST v1.1.
Has untreated brain metastases or history ofknown presence of leptomeningeal disease.
Has a history of (non-infectious) ILD/pneumonitis/pulmonary fibrosis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening.
Has a history of clinically significant cardiovascular disease
Renal function:Have an estimated glomerular filtration rate <50mL/min, based on the MDRD 4-variable formula during the screening period and on the day of the start of study treatment.