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

NCT ID: NCT04733482

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-03

Study Completion Date

2017-09-10

Brief Summary

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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

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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.

Conditions

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Body Image

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Cosmetic care

Intervention Type BEHAVIORAL

Interventions

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Cosmetic care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhenqi Lu

OTHER

Sponsor Role lead

Responsible Party

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Zhenqi Lu

Director of nursing department in Fudan University Shanghai Cancer Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shengqun Hou, Master

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Zhenqi Lu, Master

Role: STUDY_CHAIR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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FNF201413

Identifier Type: -

Identifier Source: org_study_id

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