Implementation of Shared Decision-Making in Cancer Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2020-12-31

Brief Summary

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This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A stepped wedge design, a variant of the cluster randomized controlled trial feasible to evaluate interventions in routine implementation, will be used. Participating clinics will receive the multifaceted implementation program in a randomized sequence.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Shared decision-making program

Group Type EXPERIMENTAL

Shared decision-making program

Intervention Type OTHER

The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components:

1. shared decision-making trainings for health care professionals,
2. individual coaching for physicians,
3. patient activation strategy,
4. provision of patient information material and decision aids,
5. revision of the clinics quality management documents, and
6. critical reflection of current organization of multidisciplinary team meetings.

Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.

Usual care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.

Interventions

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Shared decision-making program

The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components:

1. shared decision-making trainings for health care professionals,
2. individual coaching for physicians,
3. patient activation strategy,
4. provision of patient information material and decision aids,
5. revision of the clinics quality management documents, and
6. critical reflection of current organization of multidisciplinary team meetings.

Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.

Intervention Type OTHER

Usual Care

No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)
* admitted for inpatient or outpatient treatment at the participating clinics
* age \> 18 years
* German-speaking

* physician or nurse working at the participating clinics