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

NCT04733482 | Completed

• 1 other identifier: FNF201413
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Image

Keywords

body image; cosmetic care; psychosocial support; social avoidance and distress; young breast cancer

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (1)

• Appearance satisfaction questionnaire

  The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).

Study Arms (2)

Control group

NO INTERVENTION

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.

Cosmetic care group

EXPERIMENTAL

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

Interventions

Cosmetic care BEHAVIORAL

Cosmetic care group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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"

You may not qualify if:

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

Sponsors & Collaborators

• Zhenqi Lu: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Shengqun Hou, Master

  Fudan University

  PRINCIPAL INVESTIGATOR

• Zhenqi Lu, Master

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of nursing department in Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 2, 2021
• Study Start: January 3, 2015
• Primary Completion: September 10, 2015
• Study Completion: September 10, 2017
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

CN (1)