Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients

Breast Cancer Clinical Trial

Official title: Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients: Study Protocol for a Multicenter, Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 4.7% 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.

Setting(s): 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 1:1 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Randomized Controlled Trial

• NCT number: NCT06412133
• Study type: Interventional
• Source: China Medical University, China
• Contact: Yun-Chen Chang, phd
• Phone: +886 983503901
• Email: lisacow@mail.cmu.edu.tw
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 17, 2024
• Completion date: July 2025