NCT06412133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 17, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 8, 2024

Last Update Submit

May 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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."

    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.

    5 weeks

Study Arms (1)

intervention group

EXPERIMENTAL

photography therapy

Behavioral: photography

Interventions

photographyBEHAVIORAL

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 group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

China Medical University Hospital

Taichung, Beitun Dist, 406040, Taiwan

Location

China Medical University Hospital

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Photography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Yun-Chen Chang, phd

CONTACT

Yun-Chen Chang, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 14, 2024

Study Start

September 17, 2024

Primary Completion

December 30, 2024

Study Completion

July 1, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations