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Trial Title:
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
NCT ID:
NCT06412133
Condition:
Breast Cancer
Breast Cancer Female
Randomized Controlled Trial
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
photography
Description:
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.
Arm group label:
intervention group
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung City
Zip:
406040
Country:
Taiwan
Contact:
Last name:
Yun-Chen Chang
Phone:
0422053366
Email:
lisacow@hotmail.com
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung City
Zip:
406040
Country:
Taiwan
Contact:
Last name:
Yun-Chen Chang, phd
Phone:
0983503901
Email:
lisacow@hotmail.com
Start date:
September 17, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Yun-Chen Chang
Agency class:
Other
Collaborator:
Agency:
China Medical University, China
Agency class:
Other
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412133
