Communication in Breast Cancer Care

Not Applicable

Completed

• Conditions: Communication; Breast Cancer; Quality of Life
• Interventions: Behavioral: Communciation intervention

• Registration Number: NCT05390723
• Lead Sponsor: Leiden University

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.

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Study Start: 2022-06-05
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
video 3	Communciation intervention	the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.
video 4	Communciation intervention	the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.
video 1	Communciation intervention	The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.
video 2	Communciation intervention	The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, North Holland, Netherlands