Shared decision making on active surveillance versus immediate surgery in patients with esophageal cancer.

Shared-decision making on active surveillance versus immediate surgery in esophageal cancer patients with a clinically complete response after neoadjuvant chemoradiotherapy: the NOSANO study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27295

Enrollment

Registered

2018-11-07

Start date

2018-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Contacts

Public ContactBerend Wilk, van der

Afdeling Heelkunde, Erasmus MC, Kamer Z-836

b.vanderwilk@erasmusmc.nl0646187061

Outcome results