Clinical trial NCT04733482: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Keywords: body image
cosmetic care
psychosocial support
social avoidance and distress
young breast cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 76
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Body image scale
timeFrame: 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).
measure: Social avoidance and distress scale
timeFrame: 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:
measure: Appearance satisfaction questionnaire
timeFrame: The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Shengqun Hou, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Zhenqi Lu, Master
role: STUDY_CHAIR
References: