CommunicationNCT05390723
Communication in Breast Cancer Care
A study testing Communciation intervention in people with Communication and Breast Cancer, run by Leiden University at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Communication, Breast Cancer, Quality of Life
- What is being tested?
- Communciation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jun 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the detailed description
NA, the investigators cannot yet reveal the manipulation as it would influence the participants.
- Conditions
- Communication, Breast Cancer, Quality of Life
- Being tested
- Communciation intervention
- Keywords
- scripted video-vignette study
- Medical subject headings
- Communication, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communciation interventionBehavioural
The investigators cannot reveal the manipulated communication as this might influence participant outcomes.
| Study group | Role | What they receive |
|---|---|---|
| video 1 | Experimental | The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. Receives: Behavioral: Communciation intervention |
| video 2 | Experimental | The investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. Receives: Behavioral: Communciation intervention |
| video 3 | Experimental | the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. Receives: Behavioral: Communciation intervention |
| video 4 | Experimental | the investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. Receives: Behavioral: Communciation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)
Measured: 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
measuring the change in age, SES, education age, SES, education (7 questions)
Measured: Day 0 (day before chemo 1)
information needs
coping infromation needs ( 2 questions)
Measured: Day 0 (day before chemo 1)
anxiety
measuring the change in anxiety trait (20 questions) and current anxiety (1 question)
Measured: 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
Measured: 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)
Measured: 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)
Measured: day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start5 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, The Netherlands Cancer Institute
- Responsible party
- Principal investigator, lmvanvliet, Leiden University
- Investigators
- Liesbeth van vliet, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390723
- Sponsor's protocol ID
- N21CPB-IRBd22-103
- Other IDs
- 2022-01-07-L.M.vanVliet-V1-36
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When giving consent participations are informed that i) for storage, analysis, publication, and archiving only coded research data will be used ii) and that the coded research data might be used for further or future analysis. Anonymized data might be shared on an Open Science platform.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication in Breast Cancer Care
- ClinicalTrials.gov ID
- NCT05390723
- Acronym / sponsor ID
- N21CPB-IRBd22-103
- Conditions
- Communication, Breast Cancer, Quality of Life
- Keywords
- scripted video-vignette study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, The Netherlands Cancer Institute
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| video 1 | Experimental | Behavioral: Communciation interventionThe investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
| video 2 | Experimental | Behavioral: Communciation interventionThe investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
| video 3 | Experimental | Behavioral: Communciation interventionthe investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
| video 4 | Experimental | Behavioral: Communciation interventionthe investigators cannot yet reveal the specific communication that will be manipulate, as this might influence participant outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communciation interventionThe investigators cannot reveal the manipulated communication as this might influence participant outcomes. | Behavioural | video 1, video 2, video 3, video 4 |
Primary outcome
Anxiety
Time frame: 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
measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)
6 secondary outcomes
socio-demographics
Time frame: Day 0 (day before chemo 1)
information needs
Time frame: Day 0 (day before chemo 1)
anxiety
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: Undecided. When giving consent participations are informed that i) for storage, analysis, publication, and archiving only coded research data will be used ii) and that the coded research data might be used for further or future analysis. Anonymized data might be shared on an Open Science platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liesbeth van vliet principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communciation intervention in people with Communication and Breast Cancer, run by Leiden University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.