Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.

BACKGROUND: Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials. METHODS: The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial's consent form. The location of information in the consent forms was compared to the participants' suggestions for placement. RESULTS: 34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the "Risks" section.  3/5(60%) consents did this. CONCLUSIONS: Designing consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding.

Quality of life and decisional regret after total glossectomy with laryngectomy: A single-institution case series.

OBJECTIVES: Total glossectomy with total laryngectomy is a life-altering procedure reserved for extensive or recurrent head and neck cancer. There is minimal literature describing quality of life in these patients, partly due to high mortality rates. METHODS: Patients who had undergone a total glossectomy with laryngectomy between 2014 and 2021 at our institution, identified by chart review, were eligible. Four validated scales were used to assess quality of life and satisfaction with decision. RESULTS: Four of five survivors agreed to participate. The average scores for the Satisfaction with Decision scale and the University of Washington Quality of Life scale were 4.4/5 and 70/100, respectively, showing that patients were satisfied with their decision and quality of life. However, the average function score for the UW-QoL scale, 36.4/100, highlights negative effects of the procedure on mood, oral function, and activity. CONCLUSIONS: This case description provides a picture of patients' quality of life after total glossectomy with laryngectomy, which may be useful for counseling future patients.