Body ImageNCT04043117

Body Image and Self-esteem in Adolescence

An observational study of Body Image, run by Meyer Children's Hospital IRCCS at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To evaluate the difference between body image and self-esteem scores during and at the end of the medical. Hypothesis: body image and self-esteem changes during the oncological treatments. Read more about this study

Who is it for?: Ages 12 to 19 years
Conditions the study is for: Body Image
What is being tested?: Body Image evaluation and Self esteem evaluation
How many people: 14 participants
Where: 1 siteItaly
Study dates: 15 Sep 2017to 30 Jul 2022
Phase: Observational
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 12 to 19 years
All sexes
No healthy volunteers
Child, Adult

Study population: The Adolescents considered suitable to participate in the study on the basis of the inclusion criteria will be recruited by the investigator in the Oncohematology department and Day Hospital of the same department during the first hospitalization following the communication of the diagnosis

Who may be able to join

Age between 12 and 19 years
Adequate knowledge of the Italian language
Consent to participation
First diagnosis for oncological pathology of leukaemia or bone cancer

Who cannot join

Patients under the age of 12 or over 19 years
Not adequate knowledge of the Italian language
Patients who have a relapse with respect to the pathology already treated
Patients with previous oncological diseases
Cognitive disability
Patients with brain tumours

Show all 10Show fewer

Patients with gender dysphoria
Absence of informed consent
Previous diagnosis of Anxiety or Depression
Diagnosis of an eating disorder

Trial locations and contacts

1 site in 1 country.

Italy1 site

Meyer Children's Hospital
Florence, Florence, 50139

Other trials in Italy

About this study

Official title: Body Image and Self-esteem in a Sample of Oncological Adolescents: A Pilot Study

To evaluate the difference between body image and self-esteem scores during and at the end of the medical. Hypothesis: body image and self-esteem changes during the oncological treatments.

Read the detailed description

Body image and self-esteem represent important variables linked to adolescents' development. These two variables are the most affected in patients with the oncological disease.

The consequences of a visible difference may have a significant impact on behaviour and mood, causing relevant impairments in individuals well-being and quality of life. Among different personal attributes, self-esteem may be the one with the greatest impact on body image (Cash, 2002). Indeed previous studies have investigated different features of body image and self-esteem (Webster \& Tiggemann, 2003), showing that they have a significant influence on the overall well-being (Cash \& Fleming, 2002), and that those aspects are also significantly influenced by age and gender. The patients are evaluated at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment), according to a follow-up study design. Data analysis: r Pearson's correlation, repeated measure ANOVA and regression analysis will be carried out to investigate relations between studied variables and eventual changes over time. Analyses are performed using SPSS software (Chicago, S. P. S. S. SPSS Inc; 2008. SPSS Statistics, 17.)

Conditions: Body Image
Being tested: Body Image evaluation, Self esteem evaluation
Keywords: Dimorphism, self-esteem, oncological treatments

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Body Image evaluationOther
Evaluation of body image perception requires three assessment tools administered at four different times:
T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment
1. Italian Body Image Concern Inventory: 19-items self-report instrument rated on a 5-points Likert scale (1 = never; 5 = always). It consists of two sub-scales to evaluate body image-related dissatisfaction and concern respectively.
2. Body Uneasiness Test: 71-item self-report questionnaire on a 6-points Likert scale (0 = never; 5 = always) that consists of two subscales: BUT-A (measuring weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and body depersonalization) and BUT-B (measuring worries about specific body parts or functions).
3. Human Figure Drawing: qualitative measure of adolescent's body perception; participants are asked a free draw, representing themselves.
Self esteem evaluationOther
Evaluation of body image perception is achieved administering TMA test at four different times:
T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment
TMA (Multidimensional Self-Esteem Test): a 150-items self-report questionnaire for children and adolescents from 9 to 19 years old. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false.

Study groups in NCT04043117
Study group	Role	What they receive
Clinical Group		Group is composed by 12-19 years adolescents with a tumor (excluding brain tumor). Every patient included in the group complete the assessment including: evaluation of self-esteem (TMA test) and body image (BUT test, I-BICI test and Human Figure Drawing). Receives: Other: Body Image evaluation; Other: Self esteem evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Image perception during the path of illness
I-BICI (Italian Body Image Concern Inventory): a self-report instrument composed by 19 items rated on a 5-points Likert scale (1 = never; 5 = always). It consists of two sub-scales to evaluate body image-related dissatisfaction and concern respectively. BUT (Body Uneasiness Test): a 71-item self-report questionnaire on a 6-points Likert scale (0 = never; 5 = always) that consists of two subscales: BUT-A which measures weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and estrangement feelings towards one's own body (depersonalization); and BUT-B, which looks at specific worries about particular body parts or functions.
Measured: Evaluation at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment).
Change in self esteem levels during the path of illness
TMA (Multidimensional Self-Esteem Test): a 150-items self-report questionnaire for children and adolescents from 9 to 19 years old. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false
Measured: Evaluation at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment), according to a foll

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201730 Jul 2022

First posted2 Aug 2019
Study start15 Sep 2017
Primary completion30 Jul 2022
Study completion30 Jul 2022

Why it stopped: Study was stopped due to covid-19 sanitary restrinction in the oncology ward and day hospital.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Body ImageStudies of the same condition, open and under way.
More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
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: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04043117
Sponsor's protocol ID: Dimorphism and Self-esteem
Status last verified: Oct 2024
First submitted: 31 Jul 2019
Last updated: 17 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Decision has to be shared with the local Clinical Trial Office of the Hospital

Publications

Cash TF, Fleming EC. The impact of body image experiences: development of the body image quality of life inventory. Int J Eat Disord. 2002 May;31(4):455-60. doi: 10.1002/eat.10033.
PubMed 11948650
Gatti, E., Ionio, C., Traficante, D., & Confalonieri, E. (2014). "I Like My Body; Therefore, I Like Myself": How Body Image Influences Self-Esteem-A Cross-Sectional Study on Italian Adolescents. Europe's Journal of Psychology, 10(2), 301-317.
Pendley JS, Dahlquist LM, Dreyer Z. Body image and psychosocial adjustment in adolescent cancer survivors. J Pediatr Psychol. 1997 Feb;22(1):29-43. doi: 10.1093/jpepsy/22.1.29.
PubMed 9019046
Armstrong-James L, Cadogan J, Williamson H, Rumsey N, Harcourt D. An evaluation of the impact of a burn camp on children and young people's concerns about social situations, satisfaction with appearance and behaviour. Scars Burn Heal. 2018 Dec 10;4:2059513118816219. doi: 10.1177/2059513118816219. eCollection 2018 Jan-Dec.
PubMed 30574405
Stormer SM, Thompson JK. Explanations of body image disturbance: a test of maturational status, negative verbal commentary, social comparison, and sociocultural hypotheses. Int J Eat Disord. 1996 Mar;19(2):193-202. doi: 10.1002/(SICI)1098-108X(199603)19:23.0.CO;2-W.
PubMed 8932558
Webster J, Tiggemann M. The relationship between women's body satisfaction and self-image across the life span: the role of cognitive control. J Genet Psychol. 2003 Jun;164(2):241-52. doi: 10.1080/00221320309597980.
PubMed 12856818
Wardle J, Beales S. Restraint, body image and food attitudes in children from 12 to 18 years. Appetite. 1986 Sep;7(3):209-17. doi: 10.1016/s0195-6663(86)80026-5.
PubMed 3800362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Body Image and Self-esteem in a Sample of Oncological Adolescents: A Pilot Study
ClinicalTrials.gov ID: NCT04043117
Acronym / sponsor ID: Dimorphism and Self-esteem
Conditions: Body Image
Keywords: Dimorphism, self-esteem, oncological treatments
Study type: Observational
Recruitment status: TerminatedReason stopped: Study was stopped due to covid-19 sanitary restrinction in the oncology ward and day hospital.
Enrolment: 14 participants (actual)
Lead sponsor: Meyer Children's Hospital IRCCSUniversity, hospital or other
Study start: 15 Sep 2017 (actual)
Primary completion: 30 Jul 2022 (actual)
Study completion: 30 Jul 2022 (actual)
First posted: 2 Aug 2019 (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.

To evaluate the difference between body image and self-esteem scores during and at the end of the medical. Hypothesis: body image and self-esteem changes during the oncological treatments.

Detailed description

Body image and self-esteem represent important variables linked to adolescents' development. These two variables are the most affected in patients with the oncological disease.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Clinical Group	–	Other: Body Image evaluation, Other: Self esteem evaluationGroup is composed by 12-19 years adolescents with a tumor (excluding brain tumor). Every patient included in the group complete the assessment including: evaluation of self-esteem (TMA test) and body image (BUT test, I-BICI test and Human Figure Drawing).

Who may qualify

Ages: 12 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: The Adolescents considered suitable to participate in the study on the basis of the inclusion criteria will be recruited by the investigator in the Oncohematology department and Day Hospital of the same department during the first hospitalization following the communication of the diagnosis

Key inclusion criteria (4 listed)

Age between 12 and 19 years
Adequate knowledge of the Italian language
Consent to participation
First diagnosis for oncological pathology of leukaemia or bone cancer

Key exclusion criteria (10 listed)

Patients under the age of 12 or over 19 years
Not adequate knowledge of the Italian language
Patients who have a relapse with respect to the pathology already treated
Patients with previous oncological diseases
Cognitive disability

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
Body Image evaluationEvaluation of body image perception requires three assessment tools administered at four different times: T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment 1. Italian Body Image Concern Inventory: 19-items self-report instrument rated on a 5-points Likert scale (1 = never; 5 = always). It consists of two sub-scales to evaluate body image-related dissatisfaction and concern respectively. 2. Body Uneasiness Test: 71-item self-report questionnaire on a 6-points Likert scale (0 = never; 5 = always) that consists of two subscales: BUT-A (measuring weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and body depersonalization) and BUT-B (measuring worries about specific body parts or functions). 3. Human Figure Drawing: qualitative measure of adolescent's body perception; participants are asked a free draw, representing themselves.	Other	Clinical Group
Self esteem evaluationEvaluation of body image perception is achieved administering TMA test at four different times: T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment TMA (Multidimensional Self-Esteem Test): a 150-items self-report questionnaire for children and adolescents from 9 to 19 years old. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false.	Other	Clinical Group

Primary outcome

Change in Body Image perception during the path of illness
Time frame: Evaluation at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment).
I-BICI (Italian Body Image Concern Inventory): a self-report instrument composed by 19 items rated on a 5-points Likert scale (1 = never; 5 = always). It consists of two sub-scales to evaluate body image-related dissatisfaction and concern respectively. BUT (Body Uneasiness Test): a 71-item self-report questionnaire on a 6-points Likert scale (0 = never; 5 = always) that consists of two subscales: BUT-A which measures weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and estrangement feelings towards one's own body (depersonalization); and BUT-B, which looks at specific worries about particular body parts or functions.
Change in self esteem levels during the path of illness
Time frame: Evaluation at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment), according to a foll
TMA (Multidimensional Self-Esteem Test): a 150-items self-report questionnaire for children and adolescents from 9 to 19 years old. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false

Results and safety

The study was stopped early (reason given: Study was stopped due to covid-19 sanitary restrinction in the oncology ward and day hospital.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Results publication: PubMed 11948650Cash TF, Fleming EC. The impact of body image experiences: development of the body image quality of life inventory. Int J Eat Disord. 2002 May;31(4):455-60. doi: 10.1002/eat.10033.
Results publicationGatti, E., Ionio, C., Traficante, D., & Confalonieri, E. (2014). "I Like My Body; Therefore, I Like Myself": How Body Image Influences Self-Esteem-A Cross-Sectional Study on Italian Adolescents. Europe's Journal of Psychology, 10(2), 301-317.
Results publication: PubMed 9019046Pendley JS, Dahlquist LM, Dreyer Z. Body image and psychosocial adjustment in adolescent cancer survivors. J Pediatr Psychol. 1997 Feb;22(1):29-43. doi: 10.1093/jpepsy/22.1.29.
Results publication: PubMed 30574405Armstrong-James L, Cadogan J, Williamson H, Rumsey N, Harcourt D. An evaluation of the impact of a burn camp on children and young people's concerns about social situations, satisfaction with appearance and behaviour. Scars Burn Heal. 2018 Dec 10;4:2059513118816219. doi: 10.1177/2059513118816219. eCollection 2018 Jan-Dec.
Results publication: PubMed 8932558Stormer SM, Thompson JK. Explanations of body image disturbance: a test of maturational status, negative verbal commentary, social comparison, and sociocultural hypotheses. Int J Eat Disord. 1996 Mar;19(2):193-202. doi: 10.1002/(SICI)1098-108X(199603)19:23.0.CO;2-W.
Results publication: PubMed 12856818Webster J, Tiggemann M. The relationship between women's body satisfaction and self-image across the life span: the role of cognitive control. J Genet Psychol. 2003 Jun;164(2):241-52. doi: 10.1080/00221320309597980.
Results publication: PubMed 3800362Wardle J, Beales S. Restraint, body image and food attitudes in children from 12 to 18 years. Appetite. 1986 Sep;7(3):209-17. doi: 10.1016/s0195-6663(86)80026-5.
Individual participant dataSharing planned: Undecided. Decision has to be shared with the local Clinical Trial Office of the Hospital

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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.

Rosanna Martin, MSc principal investigator

Head of Pediatric Psychology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Body Image, run by Meyer Children's Hospital IRCCS at 1 site in Italy.

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 10 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: stopped early, as of the sponsor's last update on 17 Feb 2025. 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 Italy. 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 was stopped early (reason given: Study was stopped due to covid-19 sanitary restrinction in the oncology ward and day hospital.). Results are not available in the source record.

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?

Change in Body Image perception during the path of illness (time frame: Evaluation at T0 (within the first week of hospitalization after diagnosis), T1 (within 3 months after diagnosis), T2 (within 6 months after diagnosis), T3 (within 12 months after diagnosis, at the end of cancer treatment).). 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?

On the ClinicalTrials.gov record for NCT04043117, which also lists 7 linked publications.

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 17 Feb 2025.