NCT05390723

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

June 5, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

April 12, 2022

Last Update Submit

December 20, 2023

Conditions

CommunicationBreast CancerQuality of Life

Keywords

scripted video-vignette study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • socio-demographics

    Day 0 (day before chemo 1)

  • information needs

    Day 0 (day before chemo 1)

  • 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).

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (4)

video 1

EXPERIMENTAL

The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Behavioral: Communciation intervention

video 2

EXPERIMENTAL

The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Behavioral: Communciation intervention

video 3

EXPERIMENTAL

the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Behavioral: Communciation intervention

video 4

EXPERIMENTAL

the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes.

Behavioral: Communciation intervention

Interventions

Communciation interventionBEHAVIORAL

The investigators cannot reveal the manipulated communication as this might influence participant outcomes.

video 1video 2video 3video 4

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

Location

MeSH Terms

Conditions

CommunicationBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Liesbeth van vliet

    Leiden University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

May 25, 2022

Study Start

June 5, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations

NL(1)