Communication in Breast Cancer Care

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)

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Communication
• Intervention / Treatment: Behavioral: Communciation intervention

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066CX
      • Antoni van Leeuwenhoek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: video 1; The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.	Behavioral: Communciation intervention; The investigators cannot reveal the manipulated communication as this might influence participant outcomes.
Experimental: video 2; The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.	Behavioral: Communciation intervention; The investigators cannot reveal the manipulated communication as this might influence participant outcomes.
Experimental: video 3; the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.	Behavioral: Communciation intervention; The investigators cannot reveal the manipulated communication as this might influence participant outcomes.
Experimental: video 4; the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.	Behavioral: Communciation intervention; The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)	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 Measures

Outcome Measure	Measure Description	Time Frame
socio-demographics	measuring the change in age, SES, education age, SES, education (7 questions)	Day 0 (day before chemo 1)
information needs	coping infromation needs ( 2 questions)	Day 0 (day before chemo 1)
anxiety	measuring the change in anxiety trait (20 questions) and current anxiety (1 question)	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).
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	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
psychological outcomes	measuring the change in psychological outcomes communication satisfaction, trust, self-efficacy, distress (4 questions)	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
medical outcomes	use of co-medication (1 question)	day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed

Collaborators and Investigators

• Sponsor: Leiden University
• Collaborators: The Netherlands Cancer Institute; Dutch Cancer Society
• Investigators: Principal Investigator: Liesbeth van vliet, Leiden University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: scripted video-vignette study
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: N21CPB-IRBd22-103; 2022-01-07-L.M.vanVliet-V1-36 (Other Identifier: Dutch Cancer Institute (AVL) and Leiden University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No