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Communication in Breast Cancer Care

Primary Purpose

Communication, Breast Cancer, Quality of Life

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Communciation intervention

About this trial

This is an interventional treatment trial for Communication focused on measuring scripted video-vignette study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

Sites / Locations

Antoni van LeeuwenhoekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

video 1

video 2

video 3

video 4

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anxiety

measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)

Secondary Outcome Measures

socio-demographics

measuring the change in age, SES, education age, SES, education (7 questions)

information needs

coping infromation needs ( 2 questions)

anxiety

measuring the change in anxiety trait (20 questions) and current anxiety (1 question)

side effects (expected and experienced)

measuring the change in side effects side effects (expected) (31 questions): probability, intensity, coping, and compliance intention side effects (experienced)(21 questions): intensity, number, coping, compliance intention

psychological outcomes

measuring the change in psychological outcomes communication satisfaction, trust, self-efficacy, distress (4 questions)

medical outcomes

use of co-medication (1 question)

Full Information

NCT ID

NCT05390723

First Posted

April 12, 2022

Last Updated

September 29, 2022

Sponsor

Leiden University

Collaborators

Dutch Cancer Society, The Netherlands Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT05390723

Brief Title

Communication in Breast Cancer Care

Official Title

Communication in Breast Cancer Care

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 5, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Leiden University

Collaborators

Dutch Cancer Society, The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Communication, Breast Cancer, Quality of Life

Keywords

scripted video-vignette study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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)

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

video 1

Arm Type

Experimental

Arm Description

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

Arm Title

video 2

Arm Type

Experimental

Arm Description

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

Arm Title

video 3

Arm Type

Experimental

Arm Description

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

Arm Title

video 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Communciation intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Anxiety

Description

measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)

Time Frame

Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

Secondary Outcome Measure Information:

Title

socio-demographics

Description

measuring the change in age, SES, education age, SES, education (7 questions)

Time Frame

Day 0 (day before chemo 1)

Title

information needs

Description

coping infromation needs ( 2 questions)

Time Frame

Day 0 (day before chemo 1)

Title

anxiety

Description

measuring the change in anxiety trait (20 questions) and current anxiety (1 question)

Time Frame

trait: Day 0 (day before chemo 1), current: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and dday 52-54 (10 days after chemo 4).

Title

side effects (expected and experienced)

Description

Time Frame

expected: Day 0 (day before chemo 1); experienced: day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

Title

psychological outcomes

Description

measuring the change in psychological outcomes communication satisfaction, trust, self-efficacy, distress (4 questions)

Time Frame

Title

medical outcomes

Description

use of co-medication (1 question)

Time Frame

day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liesbeth van vliet

Phone

+31614259278

l.m.van.vliet@fsw.leidenuniv.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liesbeth van vliet

Organizational Affiliation

Leiden University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antoni van Leeuwenhoek

City

Amsterdam

State/Province

North Holland

ZIP/Postal Code

1066CX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine Heuver

Phone

0205121411

m.mes@nki.nl

First Name & Middle Initial & Last Name & Degree

Marcel Soesan, Dr

Phone

0205121287

m.soesan@nki.nl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

When giving consent participations are informed that i) for storage, analysis, publication, and archiving only coded research data will be used ii) and that the coded research data might be used for further or future analysis. Anonymized data might be shared on an Open Science platform.

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Communication in Breast Cancer Care

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