Abstract
Ideally, patient-centered trial information material encourages the discussion with the treating physician, and helps patients making trade-offs regarding treatment decisions In a situation of possible equivalent treatment options in terms of overall survival (OS), it can make it easier to weigh up advantages and disadvantages. Preferences for choice of treatment in esophageal cancer (EC) are complex, and no standardized assessment tools are available. We will explore patient’s factors for treatment choice and develop a comprehensive patient information leaflet for the inclusion into randomized controlled trials (RCT) on EC. We conduct a cross-sectional, observational study based on a mixed-methods design with patients suffering from non-metastatic EC with post-neoadjuvant complete response after neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiation (nCRT), to develop patient-centered trial information material. This pilot study is performed in a concept development phase and a subsequent pilot phase. We start with patient interviews (n = 10–15) in the concept development phase to evaluate patients’ needs, and develop a Preference and Decision Aid Questionnaire (PDAQ). We pre-test the PDAQ with another n = 10 patients with EC after nCT or nCRT, former patients from a self-help organization, and n = 10 medical experts for their comments on the questionnaire. In the pilot phase, a multicenter trial using the PDAQ and additional measures is carried out (n = 120). Based on evidence of a possible equivalence in terms of OS of the treatment options “surgery as needed” and “surgery on principle” in patients with post-neoadjuvant complete response of EC, this pilot study on patient participation is conducted to assess patient’s needs and preferences, and optimize patients’ inclusion in a planned RCT. The aim is to develop patient-centered trial information material for the RCT to increase patients’ consent and compliance with the randomized treatment. The trial is registered at the German Clinical Trials Register (DRKS00022050, October 15, 2020).
Highlights
Patient-centered health care considers patients and professionals as partners and has its focus on the individual patient’s treatment preferences and needs
The results suggest that both post-neoadjuvant treatments are feasible to evaluate in a prospective and comparative clinical trial for complete clinical responders without compromising on overall survival (OS)
The purpose of the study is to develop patient-centered trial information material to be used in the planned randomized controlled trials (RCTs) designed to compare the treatment regimens “surgery as needed” and “surgery on principle” in patients with post-neoadjuvant complete response of esophageal cancer (EC) with respect to OS
Summary
Patient-centered health care considers patients and professionals as partners and has its focus on the individual patient’s treatment preferences and needs. Overall HRQL in long-term survivors after esophagectomy did not improve between 6 months and 3 years after surgery, and was worse than that in a comparable reference population [12] Another as equivalent hypothesized treatment option following nCRT or nCT in terms of overall patient survival is close surveillance with surgery only as needed in persisting or recurring loco-regional tumor [13]. Patients without histologic evidence of local residual disease, without loco-regional metabolic positive lymph nodes and without evidence for distant metastasis will be considered to be clinically complete responders (“clinical CR”) and will be to directly proceed with consecutive close-meshed surveillance visits with surgery only in the event of a local tumor recurrence. The factors influencing patients’ treatment preferences for choice of treatment in esophageal cancer are complex, and no standardized assessment tools are available
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