Communication in Breast Cancer Care

Breast Cancer Clinical Trial

Official title:

Communication in Breast Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390723
• Other study ID #: N21CPB-IRBd22-103
• Secondary ID: 2022-01-07-L.M.v
• Status: Completed
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Communication
• Quality of Life

Intervention

Behavioral:
• Communciation intervention
The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam	North Holland

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University	Dutch Cancer Society, The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	socio-demographics	measuring the change in age, SES, education age, SES, education (7 questions)	Day 0 (day before chemo 1)
Secondary	information needs	coping infromation needs ( 2 questions)	Day 0 (day before chemo 1)
Secondary	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).
Secondary	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
Secondary	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
Secondary	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