Communication in Breast Cancer Care

Study Overview
=================
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.

Official Title
-----------------
Communication in Breast Cancer Care

Conditions
-----------------
Communication, Breast Cancer, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Communciation intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scripted video-vignette study