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Communication in Breast Cancer Care

NCT ID: NCT05390723

Last Updated: 2023-12-21

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-05

Study Completion Date

2023-09-01

Brief Summary

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The investigators will create 4 information-video's about chemotherapy side-effects in curative breast cancer care. The communication is manipulated in the four videos. Participants will watch the video before the first chemotherapy and complete questionnaires before and after viewing the video and after chemotherapy 1,2 and 4. (The investigators cannot yet reveal the manipulation as it would influence the participants)

Detailed Description

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NA, the investigators cannot yet reveal the manipulation as it would influence the participants.

Conditions

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Communication Breast Cancer Quality of Life

Keywords

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scripted video-vignette study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-centre proof-of-principle RCT will be conducted using a scripted video-design. Four different information-videos about chemotherapy's side effects are created in which specific communication is manipulated to assess their effect on patient (psychological/cognitive/physical outcomes. (The investigators cannot yet reveal the manipulation as it would influence our participants)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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video 1

The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Group Type EXPERIMENTAL

Communciation intervention

Intervention Type BEHAVIORAL

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

video 2

The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Group Type EXPERIMENTAL

Communciation intervention

Intervention Type BEHAVIORAL

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

video 3

the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Group Type EXPERIMENTAL

Communciation intervention

Intervention Type BEHAVIORAL

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

video 4

the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Group Type EXPERIMENTAL

Communciation intervention

Intervention Type BEHAVIORAL

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

Interventions

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Communciation intervention

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult (\>18 years old) female breast cancer patients
* Chemo-naïve patients
* Scheduled in for curative neo-adjuvant chemotherapy: Four courses of AC chemotherapy (all combinations of AC + other chemotherapy courses are eligible)
* Cognitively able to fill out an online questionnaire
* Having internet access
* Sufficient command of the Dutch language
* pre-chemo no previous treatment or pre-chemo breast-conserving surgery and radiotherapy (WLE patients)

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Leiden University

OTHER

Sponsor Role lead

Responsible Party

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lmvanvliet

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liesbeth van vliet

Role: PRINCIPAL_INVESTIGATOR

Leiden University

Locations

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Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2022-01-07-L.M.vanVliet-V1-36

Identifier Type: OTHER

Identifier Source: secondary_id

N21CPB-IRBd22-103

Identifier Type: -

Identifier Source: org_study_id