No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is increased knowledge and understanding of the factors relevant for treatment decision making in esophageal cancer patients. Based on the analyses of the interview data, we will develop a model/theory on the factors that influence treatment decision in esophageal cancer patients. This theory, combined with results of the quantative part of this study, will determine the design of the decision aid. This decision aid is a tangible main outcome/endpoint of this study and meant for future use in clinical practice
Secondary outcome
Secondary study parameters include data on the relationship between treatment decision on the one hand and on the other hand health literacy, anxiety, coping, quality of life and decisional regret.
Background summary
In around 30% of patients who undergo standard esophagectomy after neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, no vital tumors can be found in the resection specimen (pCR). A current Dutch cluster-randomized study (SANO) investigates if organ sparing approaches can be offered after having reached a clinical complete response after nCRT . This so-called active surveillance approach will possibly offer patients an alternative next to standard surgery after nCRT. Those who undergo an active surveillance approach will undergo frequent additional investigations and will only be offered esophagectomy if recurrent disease is proven or highly suspected. Patients might have strong preferences for either approach. This will require complex decision making on complex matters, both for patients and physicians.
Study objective
Patients benefit from shared decision making and this results in a well chosen treatment decision.
Study design
Three questionnaires:
T0: before pretreatment
T1: 3 months after completion of pretreatment
T2: 9 months after surgery
Intervention
NA
Berend Wilk, van der
Postbus 2040
Rotterdam 3000 CA
The Netherlands
0646187061
b.vanderwilk@erasmusmc.nl
Berend Wilk, van der
Postbus 2040
Rotterdam 3000 CA
The Netherlands
0646187061
b.vanderwilk@erasmusmc.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Patients who are planned to undergo neoadjuvant chemoradiotherapy according to CROSS, followed by either surgical resection for histologically proven and resectable esophageal squamous cell carcinoma or adenocarcinoma of the esophagus or esophago-gastric junction, without distant dissemination or by active surveillance.
-Age ¡Ý18
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
-Language difficulty, dementia or altered mental status prohibiting the understanding
and giving of informed consent and to complete the questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7345 |
| NTR-old | NTR7610 |
| Other | : MEC-2018-1526 |