Manuel Czornik, Joachim Weis, Andrea Kiemen, Claudia Schmoor, Julian Hipp, Jens Hoeppner
{"title":"关于新辅助治疗后肿瘤完全反应的随机对照试验的需求、偏好和患者参与情况:食管癌患者的定性研究","authors":"Manuel Czornik, Joachim Weis, Andrea Kiemen, Claudia Schmoor, Julian Hipp, Jens Hoeppner","doi":"10.1007/s00520-024-08845-0","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>For patients with clinical complete response of non-metastatic esophageal cancer (EC) after neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT), the two treatment options obligate postneoadjuvant surgery as the current standard treatment (surgery on principle) versus active surveillance with surgery as needed only in recurring loco-regional tumor as a possible future alternative or standard exist. Since these treatments are presumably equivalent in terms of overall survival, patient-centered information can encourage the discussion with the treating physician and can make it easier for patients to make trade-offs between the advantages and disadvantages of the treatment alternatives in a highly distressed situation.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A qualitative prospective cross-sectional study was conducted to create patient-centered information material that is based on patients’ preferences, needs, and concerns regarding the two treatment options, and to investigate the potential participation in a consecutive randomized controlled trial (RCT). Therefore, EC patients (<i>N</i> = 11) were asked about their attitudes.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Concerns about the surgery and possible postoperative impairments in quality of life were identified as most mentioned negative aspects of surgery on principle, and recurrence and progression fear and the concern that surgery cannot be avoided anyways as most named negative aspects of surgery as needed. In regard to the participation in an RCT, making a contribution to science and the hope that the novel therapy would be superior to the established one were relevant arguments to participate. On the other hand, the lack of a proactive selection of treatment was named an important barrier to participation in an RCT.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>The importance of adapting medical conversations to the patients’ lack of expertise and their exceptional cognitive and emotional situation is stressed. Results of this study can be used to improve patient-centered information and the recruitment of patients in RCTs in cancer.</p>","PeriodicalId":22046,"journal":{"name":"Supportive Care in Cancer","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Needs, preferences, and patient participation for a randomized controlled trial on postneoadjuvant complete tumor response: A qualitative study of patients with esophageal cancer\",\"authors\":\"Manuel Czornik, Joachim Weis, Andrea Kiemen, Claudia Schmoor, Julian Hipp, Jens Hoeppner\",\"doi\":\"10.1007/s00520-024-08845-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Purpose</h3><p>For patients with clinical complete response of non-metastatic esophageal cancer (EC) after neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT), the two treatment options obligate postneoadjuvant surgery as the current standard treatment (surgery on principle) versus active surveillance with surgery as needed only in recurring loco-regional tumor as a possible future alternative or standard exist. Since these treatments are presumably equivalent in terms of overall survival, patient-centered information can encourage the discussion with the treating physician and can make it easier for patients to make trade-offs between the advantages and disadvantages of the treatment alternatives in a highly distressed situation.</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>A qualitative prospective cross-sectional study was conducted to create patient-centered information material that is based on patients’ preferences, needs, and concerns regarding the two treatment options, and to investigate the potential participation in a consecutive randomized controlled trial (RCT). Therefore, EC patients (<i>N</i> = 11) were asked about their attitudes.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>Concerns about the surgery and possible postoperative impairments in quality of life were identified as most mentioned negative aspects of surgery on principle, and recurrence and progression fear and the concern that surgery cannot be avoided anyways as most named negative aspects of surgery as needed. In regard to the participation in an RCT, making a contribution to science and the hope that the novel therapy would be superior to the established one were relevant arguments to participate. On the other hand, the lack of a proactive selection of treatment was named an important barrier to participation in an RCT.</p><h3 data-test=\\\"abstract-sub-heading\\\">Conclusion</h3><p>The importance of adapting medical conversations to the patients’ lack of expertise and their exceptional cognitive and emotional situation is stressed. 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Needs, preferences, and patient participation for a randomized controlled trial on postneoadjuvant complete tumor response: A qualitative study of patients with esophageal cancer
Purpose
For patients with clinical complete response of non-metastatic esophageal cancer (EC) after neoadjuvant chemoradiotherapy (nCRT) or neoadjuvant chemotherapy (nCT), the two treatment options obligate postneoadjuvant surgery as the current standard treatment (surgery on principle) versus active surveillance with surgery as needed only in recurring loco-regional tumor as a possible future alternative or standard exist. Since these treatments are presumably equivalent in terms of overall survival, patient-centered information can encourage the discussion with the treating physician and can make it easier for patients to make trade-offs between the advantages and disadvantages of the treatment alternatives in a highly distressed situation.
Methods
A qualitative prospective cross-sectional study was conducted to create patient-centered information material that is based on patients’ preferences, needs, and concerns regarding the two treatment options, and to investigate the potential participation in a consecutive randomized controlled trial (RCT). Therefore, EC patients (N = 11) were asked about their attitudes.
Results
Concerns about the surgery and possible postoperative impairments in quality of life were identified as most mentioned negative aspects of surgery on principle, and recurrence and progression fear and the concern that surgery cannot be avoided anyways as most named negative aspects of surgery as needed. In regard to the participation in an RCT, making a contribution to science and the hope that the novel therapy would be superior to the established one were relevant arguments to participate. On the other hand, the lack of a proactive selection of treatment was named an important barrier to participation in an RCT.
Conclusion
The importance of adapting medical conversations to the patients’ lack of expertise and their exceptional cognitive and emotional situation is stressed. Results of this study can be used to improve patient-centered information and the recruitment of patients in RCTs in cancer.
期刊介绍:
Supportive Care in Cancer provides members of the Multinational Association of Supportive Care in Cancer (MASCC) and all other interested individuals, groups and institutions with the most recent scientific and social information on all aspects of supportive care in cancer patients. It covers primarily medical, technical and surgical topics concerning supportive therapy and care which may supplement or substitute basic cancer treatment at all stages of the disease.
Nursing, rehabilitative, psychosocial and spiritual issues of support are also included.