Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
Conversations in Light and Shadow Assessing Phototherapys Impact on Breast Cancer Patients
Sponsor:
Yun-Chen Chang
Organization:
China Medical University China
Study Overview
Official Title:
Conversations in Light and Shadow Assessing Phototherapys Impact on Breast Cancer Patients Study Protocol for a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study examines the impact of phototherapy intervention on anxiety stress and body image among breast cancer patients Participants engaged in a five-week one-on-one session series utilizing a pre-post-test design with parallel groups Quantitative data were collected using the Depression Anxiety Stress Scales DASS-21 and the Body Image Scale In addition to quantitative measures in-depth individual interviews were conducted to gather qualitative data The combined data were then analysed to assess the effectiveness of the intervention
Detailed Description:
Background Breast cancer ranks as the most prevalent cancer among women in Taiwan According to statistical data breast cancer patients face a risk of recurrence ranging from 47 to 50 within five years post-treatment The repeated cycles of occurrence and treatment not only cause physiological changes but also significant psychological stress particularly in response to mastectomies and altered body image perceptions all of which can adversely affect quality of life However current interventions in Taiwan such as phototherapy primarily aim to improve life quality and intimate relationships with scant in-depth research focusing on the impacts on body image
Objective This study investigates whether phototherapy intervention can ameliorate psychological issues in breast cancer patients by focusing on three aspects anxiety stress and body image The research aims to address gaps in existing knowledge regarding the effectiveness of such interventions on these specific psychological dimensions
Design and Methods This study examines the impact of phototherapy intervention on anxiety stress and body image among breast cancer patients Participants engaged in a five-week one-on-one session series utilizing a pre-post-test design with parallel groups Quantitative data were collected using the Depression Anxiety Stress Scales DASS-21 and the Body Image Scale In addition to quantitative measures in-depth individual interviews were conducted to gather qualitative data The combined data were then analysed to assess the effectiveness of the intervention
Settings The study will be conducted across five medical centers in Taiwan
Participants The study included 1-3 stage breast cancer patients aged between 20 and 55 years who provided informed consent Due to the exploratory nature of the research a formal sample size analysis was not conducted However it was deemed that the anticipated sample size for the quantitative aspect of the study was sufficiently large n 78 to obtain precise point estimates Interventions were planned to be allocated to eligible breast cancer patients in a 11 ratio Variables will be described using absolute and relative frequencies means medians and relevant distribution estimates based on the measurement level The primary outcomes will be described using paired t-tests and independent-samples t-tests
Results The study commenced in September 2024 with results expected to be available by July 2025
Objective This study investigates whether phototherapy intervention can ameliorate psychological issues in breast cancer patients by focusing on three aspects anxiety stress and body image The research aims to address gaps in existing knowledge regarding the effectiveness of such interventions on these specific psychological dimensions
Design and Methods This study examines the impact of phototherapy intervention on anxiety stress and body image among breast cancer patients Participants engaged in a five-week one-on-one session series utilizing a pre-post-test design with parallel groups Quantitative data were collected using the Depression Anxiety Stress Scales DASS-21 and the Body Image Scale In addition to quantitative measures in-depth individual interviews were conducted to gather qualitative data The combined data were then analysed to assess the effectiveness of the intervention
Settings The study will be conducted across five medical centers in Taiwan
Participants The study included 1-3 stage breast cancer patients aged between 20 and 55 years who provided informed consent Due to the exploratory nature of the research a formal sample size analysis was not conducted However it was deemed that the anticipated sample size for the quantitative aspect of the study was sufficiently large n 78 to obtain precise point estimates Interventions were planned to be allocated to eligible breast cancer patients in a 11 ratio Variables will be described using absolute and relative frequencies means medians and relevant distribution estimates based on the measurement level The primary outcomes will be described using paired t-tests and independent-samples t-tests
Results The study commenced in September 2024 with results expected to be available by July 2025
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