Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230068
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-24
First Post:
2024-01-08
Brief Title:
ExBRAC - Expressive Writing in Breast Cancer
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
ExBRAC - Expressive Writing in Breast Cancer - Bröstcancer Och Intensivt Skrivande
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExBRAC
Brief Summary:
The EXBRAC pilot study will investigate the quality of life of patients with breast cancer and the effect of an intervention with expressive writing This is a pilot study with two purposes the first is to create a questionnaire specifically developed for the ExBRAC study and the second to evaluate the feasibility of the expressive writing
Detailed Description:
In the first stage of the study patients newly diagnosed with breast cancer will be interviewed using a semi-structured method Based on the transcriptions from the interviews themes will be gathered and transformed into questions The questions will be compiled into a questionnaire and an expert group will review the questionnaire to ensure no topic is lacking and an adequate number of response options is present Lastly the questionnaire will be face-to-face validated meaning a patient completes it with a research nurse present to apprehend any ambiguities or questions needing clarification
In the second part of the pilot study patients will be included to test the feasibility of the interventions consisting of expressive writing The intervention consists of expressive writing during 20 minutes The writing should be of the breast cancer the treatment or other related topics The patient is invited to write once every week in a separate place The intervention ends after four weeks The written text is not collected In the pilot study the intervention will be followed by a telephone call about five weeks after inclusion To test the feasibility of the intervention 20 to 25 included patient is considered sufficient
In the second part of the pilot study patients will be included to test the feasibility of the interventions consisting of expressive writing The intervention consists of expressive writing during 20 minutes The writing should be of the breast cancer the treatment or other related topics The patient is invited to write once every week in a separate place The intervention ends after four weeks The written text is not collected In the pilot study the intervention will be followed by a telephone call about five weeks after inclusion To test the feasibility of the intervention 20 to 25 included patient is considered sufficient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None