Clinical trial NCT06412133: Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
Official title: Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients: Study Protocol for a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Randomized Controlled Trial
Lead sponsor: China Medical University, China
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2024-05-14
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 5 weeks
measure: body image scale (BIS)
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Beitun Dist
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: