The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy

January 28, 2021 updated by: Zhenqi Lu
This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. This was a single-center, 2-arm quasi-experimental study. The control group received usual care, while cosmetic care was added to the intervention group. The primary outcomes were BI and SAD accompanying chemotherapy, and the secondary outcome was the appearance satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The diagnosis and treatment of breast cancer may still bring severe psychological trauma to women. Cosmetic care is an effective measure to enhance patients' psychosocial functioning, which can help cancer patients cope with disfigurement-related adverse effects.

Objectives: This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy.

Study design: This was a prospective, 2-arm quasi-experimental study, comprising two groups: the controlled group and the interventional group. In order to avoid interference, the two groups of participants were recruited at different periods. The control group was recruited from Jan 2015 to Mar 2015, and the intervention group was recruited from January 2016 to September 2017. All participants came from the department of a breast surgery in Shanghai, China.

Control condition: Participants in the control group received usual care during adjuvant chemotherapy.

Intervention: Participants in the intervention group received cosmetic care in combination with usual care.

Ethical approval: Ethical approval of this study was obtained from the ethical committee of a cancer center in Shanghai. The approval number was 1403132-2. Informed consent was explained to the participants and the forms were signed by them.

Data analyses: The IBM SPSS 22.0 was used to analyze all the data.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primary breast cancer patients
  • Aged 18-40 years old, who received surgery and adjuvant chemotherapy in our department
  • No prior neoadjuvant chemotherapy
  • Being available to communicate by the novel social application "Wechat"

Exclusion Criteria:

  • Diagnosis of psychiatric or intellectual impairment
  • Having a history of neoadjuvant therapy
  • Having distant metastasis
  • ECOG<2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants in the control group received usual care during adjuvant chemotherapy. The usual care consisted of written information and verbal guidance on the adverse effects of chemotherapy and related psychological reactions.
Experimental: Cosmetic care group
Participants in the intervention group received cosmetic care in combination with usual care. The cosmetic care was a 3-hour, free-of-charge beauty activity, including face moisturizing steps, make-up, wigs, and breast prostheses wearing. It was provided by professional cosmeticians at a cosmetic training base before the patients finished half of their chemotherapy cycle.
Behavioral: Cosmetic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body image scale
Time Frame: Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally).
Body image (BI) was assessed using the body image scale. It is a 10-item self-assessment scale, measuring cancer patients' perception of their appearance. The minimum and maximum values of the scale are 0 and 30. A higher score signifies a worse BI.
Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally).
Social avoidance and distress scale
Time Frame: Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.)
Social avoidance and distress (SAD) was assessed using social avoidance and distress scale, which contains 28 items. The total score in the scale ranges from 0 to 28. A higher score means greater SAD.
Change from baseline to half of the cycle of chemotherapy and the end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance satisfaction questionnaire
Time Frame: The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).
The appearance satisfaction questionnaire was designed by the researchers of this study, and aimed to assess whether the several body image- related side effects of treatments would affect patients' appearance satisfaction. It involved six aspects: hair loss, facial skin pigmentation, acne skin, breast loss, weight gain, and fatigue. The answers included either a "Yes" or a "No." The description of each item was used percentage.
The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhenqi Lu

Investigators

  • Principal Investigator: Shengqun Hou, Master, Fudan University
  • Study Chair: Zhenqi Lu, Master, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2015

Primary Completion (Actual)

September 10, 2015

Study Completion (Actual)

September 10, 2017

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNF201413

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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