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

NCT ID: NCT06412133

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-07-31

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 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.

Conditions

Breast Cancer; Breast Cancer Female; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

intervention group

photography therapy

Group Type: EXPERIMENTAL

photography

Intervention Type: BEHAVIORAL

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.

Interventions

photography

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of stage 1-3 breast cancer within the past five years,
• Aged between 20 and 55 years,
• Ability to communicate in Mandarin or Taiwanese,
• Ownership of a mobile phone and proficiency in using it for photography,
• Willingness to participate in the study, and capacity to provide informed consent

Exclusion Criteria

• Individuals with a documented history of severe mental illness,
• Diagnosis of stage 4 breast cancer
• Current engagement in other adjunctive therapies

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: collaborator

Yun-Chen Chang

OTHER

Sponsor Role: lead

Responsible Party

Yun-Chen Chang

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

China Medical University Hospital

Taichung, Beitun Dist, Taiwan

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Yun-Chen Chang, phd

Role: CONTACT

lisacow@mail.cmu.edu.tw

+886 983503901 ext. 7113

Yun-Chen Chang, phd

Role: CONTACT

lisacow@hotmail.com

+886 0422053366 ext. 7113

Facility Contacts

Yun-Chen Chang

Role: primary

lisacow@hotmail.com

0422053366

Yun-Chen Chang, phd

Role: primary

lisacow@hotmail.com

0983503901

Other Identifiers

CMUH113

Identifier Type: -

Identifier Source: org_study_id