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

Body Image Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733482
• Other study ID #: FNF201413
• Status: Completed
• Phase: N/A
• Start date: January 3, 2015
• Est. completion date: September 10, 2017

Study information

• Verified date: January 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 10, 2017
• Est. primary completion date: September 10, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Breast Neoplasms

Intervention

Behavioral:
• Cosmetic care

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhenqi Lu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body image scale	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).
Primary	Social avoidance and distress scale	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	Appearance satisfaction questionnaire	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.).