Clinical trial NCT05390723: Communication in Breast Cancer Care
Official title: Communication in Breast Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Breast Cancer
Quality of Life
Keywords: scripted video-vignette study
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: The Netherlands Cancer Institute
First posted: 2022-05-25
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety
timeFrame: 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 outcomes:
measure: socio-demographics
timeFrame: Day 0 (day before chemo 1)
measure: information needs
timeFrame: Day 0 (day before chemo 1)
measure: anxiety
timeFrame: 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).
measure: side effects (expected and experienced)
timeFrame: 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
measure: psychological outcomes
timeFrame: 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
measure: medical outcomes
timeFrame: day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
state: North Holland
Study officials:
affiliation: Leiden University
name: Liesbeth van vliet
role: PRINCIPAL_INVESTIGATOR
References: