Communication in Breast Cancer Care

Sponsor

Leiden University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05390723

Collaborator

Dutch Cancer Society (Other), The Netherlands Cancer Institute (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Communication Breast Cancer Quality of Life	Behavioral: Communciation intervention	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)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 (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Communication in Breast Cancer Care

Anticipated Study Start Date :

Jun 2, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Anxiety [Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 56-58 (2 weeks 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

socio-demographics [Day 0 (day before chemo 1)]
measuring the change in age, SES, education age, SES, education (7 questions)
information needs [Day 0 (day before chemo 1)]
coping infromation needs ( 2 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 day 56-58 (2 weeks 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 56-58 (2 weeks 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
psychological outcomes [Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 56-58 (2 weeks 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 58 (2 weeks 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Leiden University
Dutch Cancer Society
The Netherlands Cancer Institute

Investigators

Principal Investigator: Liesbeth van vliet, Leiden University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

lmvanvliet, Assistant Professor, Leiden University

ClinicalTrials.gov Identifier:

NCT05390723

Other Study ID Numbers:

N21CPB-IRBd22-103
2022-01-07-L.M.vanVliet-V1-36

First Posted:

May 25, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by lmvanvliet, Assistant Professor, Leiden University

scripted video-vignette study

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 3, 2022