Body ImageNCT04733482
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy
A study testing Cosmetic care in people with Body Image, run by Zhenqi Lu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Body Image
- What is being tested?
- Cosmetic care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2015to 10 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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"
Who cannot join
- Diagnosis of psychiatric or intellectual impairment
- Having a history of neoadjuvant therapy
- Having distant metastasis
- ECOG<2
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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.
Read the 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.
- Conditions
- Body Image
- Being tested
- Cosmetic care
- Keywords
- body image, cosmetic care, psychosocial support, social avoidance and distress, young breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cosmetic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start3 Jan 2015
- Primary completion10 Sep 2015
- Study completion10 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhenqi Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenqi Lu, Fudan University
- Investigators
- Shengqun Hou, Master, Principal investigator, Fudan UniversityZhenqi Lu, Master, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733482
- Sponsor's protocol ID
- FNF201413
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04733482
- Acronym / sponsor ID
- FNF201413
- Conditions
- Body Image
- Keywords
- body image, cosmetic care, psychosocial support, social avoidance and distress, young breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Zhenqi LuUniversity, hospital or other
- Study start
- 3 Jan 2015 (actual)
- Primary completion
- 10 Sep 2015 (actual)
- Study completion
- 10 Sep 2017 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Cosmetic careParticipants 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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"
Key exclusion criteria (4 listed)
- Diagnosis of psychiatric or intellectual impairment
- Having a history of neoadjuvant therapy
- Having distant metastasis
- ECOG<2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic care | Behavioural | Cosmetic care group |
Primary outcome
Body image scale
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).
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
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.)
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.
1 secondary outcome
Appearance satisfaction questionnaire
Time frame: The end of cycle of chemotherapy (each cycle is 21 days, and there were 4-6 cycles totally.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengqun Hou, Master principal investigator
Fudan University
Zhenqi Lu, Master study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic care in people with Body Image, run by Zhenqi Lu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body image scale (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.