University of California Davis Medical Center 95817 Sacramento United StatesRekrutierend» Google-MapsHartford HealthCare 06102 Hartford United StatesRekrutierend» Google-Maps Ansprechpartner: Emily Shearier» Ansprechpartner anzeigenUniversity of Florida Health Shands Hospital 32608 Gainesville United StatesRekrutierend» Google-Maps
1. Overall Survival (Time Frame - 5 years): as measured by death from any cause.
Secondary outcome:
1. Patient Anxiety (Time Frame - 5 years): The PROMIS® Cancer-Anxiety instrument assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS® Cancer-Anxiety instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's responses will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of anxiety.
2. Patient Satisfaction (Time Frame - 5 years): The PROMIS® Satisfaction with Social Roles & Activities instrument assesses satisfaction with performing one's usual social roles and activities (e.g., 'I am satisfied with my ability to participate in family activities'). This instrument is a computer adaptive test. A minimum of 4 questions must be answered. One's response will guide the system's choice of the next question. The test will continue until either the standard error drops below a specified level or the participant has answered the maximum number of 12 questions (whichever comes first). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 4 and the highest possible raw score is 60. The raw score will then be converted into a standardized T-score for each participant using the applicable conversion table. A higher T-score represents a higher degree of satisfaction.
3. Patient Quality-of-Life (Time Frame - 5 years): The validated EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaire measures generic health status and consists of 2 sections: the descriptive system and the Visual Analogue Scale (VAS). The descriptive system is comprised of 5 dimensions (mobility, self care, usual activities, pain / discomfort and anxiety / depression). Each question has 5 response options ranging in value from 1 to 5. To find the raw score, sum the values of the response to each question. The lowest possible raw score is 5 and the highest is 25. A lower raw score in the descriptive system represents fewer issues with each of the 5 domains. The VAS records a participant's self-rated health from 0 to 100 on a vertical VAS with endpoints labeled '100 - the best health you can imagine' and '0 - the worst health you can imagine'. The participant is asked to mark an 'X' on the scale and write the corresponding number, which is this section's raw score.
4. Local Recurrence-Free Survival (Time Frame - 5 years): As measured by the length of time from the time of randomization that the participant survives with no detection of recurrent disease at the initial tumor site or operative field.
5. Metastasis-Free Survival (Time Frame - 5 years): As measured by as the length of time from the time of randomization that the participant survives with no detection of systemic disease recurrence at any anatomic location.
6. Treatment-Related Complications (Time Frame - 5 years): Will include both chemotherapy-related complications, such as febrile neutropenia, fungal infections or sepsis, and thoracotomy-related complications, such as pneumothorax or surgical site infections.
7. Net Healthcare Costs (Time Frame - 5 years): Will include both the net costs of surveillance and costs incurred from metastasis treatment and metastasis treatment-related complications.
