search
Back to results

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

Primary Purpose

Body Image

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cosmetic care
Sponsored by
Zhenqi Lu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Body Image focused on measuring body image, cosmetic care, psychosocial support, social avoidance and distress, young breast cancer

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Cosmetic care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 24, 2021
Last Updated
January 28, 2021
Sponsor
Zhenqi Lu
search

1. Study Identification

Unique Protocol Identification Number
NCT04733482
Brief Title
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy
Official Title
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2015 (Actual)
Primary Completion Date
September 10, 2015 (Actual)
Study Completion Date
September 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhenqi Lu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Image
Keywords
body image, cosmetic care, psychosocial support, social avoidance and distress, young breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cosmetic care group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cosmetic care
Primary Outcome Measure Information:
Title
Body image scale
Description
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.
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).
Title
Social avoidance and distress scale
Description
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.
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.)
Secondary Outcome Measure Information:
Title
Appearance satisfaction questionnaire
Description
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.
Time Frame
The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengqun Hou, Master
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhenqi Lu, Master
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs