Breast CancerNCT06412133
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
A study testing photography in people with Breast Cancer and Breast Cancer Female, run by Yun-Chen Chang at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Randomized Controlled Trial
- What is being tested?
- photography
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Sep 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals with a documented history of severe mental illness,
- Diagnosis of stage 4 breast cancer
- Current engagement in other adjunctive therapies
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
China Medical University Hospital
Taichung, Beitun Dist, 406040
Yun-Chen Chang, 0422053366, lisacow@hotmail.com
China Medical University Hospital
Taichung, 406040
Yun-Chen Chang, phd, 0983503901, lisacow@hotmail.com
About this study
Official title: Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients: Study Protocol for a Multicenter, Randomized Controlled Trial
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.
Read the 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.
- Being tested
- photography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photographyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | photography therapy Receives: Behavioral: photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS-21)
Depression Anxiety Stress Scales (DASS-21) developed by Lovibond and Lovibond (1995) is a structured emotional assessment tool. Higher scores on the scale indicate higher levels of depression, anxiety, and stress. The Cronbach's α values for the depression, anxiety, and stress subscales are 0.94, 0.87, and 0.91, respectively, indicating good reliability and internal consistency. The current prevalent version consists of 21 items (DASS-21), with scores interpreted as follows: 0 means "does not apply to me at all," 1 means "applies to me to some degree, or some of the time," 2 means "applies to me to a considerable degree, or a good part of the time," and 3 means "applies to me very much, or most of the time."
Measured: 5 weeks
body image scale (BIS)
Body Image Scale used in this study was assessed by Hopwood et al. (2001) among breast cancer patients, with an internal consistency Cronbach's α value of 0.85. After re-assessment among breast cancer patients, the internal consistency Cronbach's α value improved to 0.93, indicating good reliability and test-retest reliability. This study utilized the Body Image Scale translated by Lin (2009) for assessment. This scale consists of 10 reverse-scored questions, with scores ranging from 10 to 40. Higher scores indicate a more negative body image tendency.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start17 Sep 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun-Chen Chang
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor-investigator, Yun-Chen Chang, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412133
- Sponsor's protocol ID
- CMUH113
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients: Study Protocol for a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06412133
- Acronym / sponsor ID
- CMUH113
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Yun-Chen ChangUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- 17 Sep 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: photographyphotography therapy |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals with a documented history of severe mental illness,
- Diagnosis of stage 4 breast cancer
- Current engagement in other adjunctive therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photographyThis 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. | Behavioural | intervention group |
Primary outcome
Depression Anxiety Stress Scale (DASS-21)
Time frame: 5 weeks
Depression Anxiety Stress Scales (DASS-21) developed by Lovibond and Lovibond (1995) is a structured emotional assessment tool. Higher scores on the scale indicate higher levels of depression, anxiety, and stress. The Cronbach's α values for the depression, anxiety, and stress subscales are 0.94, 0.87, and 0.91, respectively, indicating good reliability and internal consistency. The current prevalent version consists of 21 items (DASS-21), with scores interpreted as follows: 0 means "does not apply to me at all," 1 means "applies to me to some degree, or some of the time," 2 means "applies to me to a considerable degree, or a good part of the time," and 3 means "applies to me very much, or most of the time."
body image scale (BIS)
Time frame: 5 weeks
Body Image Scale used in this study was assessed by Hopwood et al. (2001) among breast cancer patients, with an internal consistency Cronbach's α value of 0.85. After re-assessment among breast cancer patients, the internal consistency Cronbach's α value improved to 0.93, indicating good reliability and test-retest reliability. This study utilized the Body Image Scale translated by Lin (2009) for assessment. This scale consists of 10 reverse-scored questions, with scores ranging from 10 to 40. Higher scores indicate a more negative body image tendency.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photography in people with Breast Cancer and Breast Cancer Female, run by Yun-Chen Chang at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-Chen Chang, phd (+886 983503901 ext. 7113, lisacow@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS-21) (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.