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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04043117
Other study ID # Dimorphism and Self-esteem
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 15, 2017
Est. completion date July 30, 2022

Study information

Verified date August 2022
Source Meyer Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.)


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 19 Years
Eligibility Inclusion criteria for patients: - 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 Exclusion criteria for pediatric patients: - 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 - Patients with gender dysphoria - Absence of informed consent - Previous diagnosis of Anxiety or Depression - Diagnosis of an eating disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Body Image evaluation
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 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. 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). Human Figure Drawing: qualitative measure of adolescent's body perception; participants are asked a free draw, representing themselves.
Self esteem evaluation
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.

Locations

Country Name City State
Italy Meyer Children's Hospital Florence

Sponsors (1)

Lead Sponsor Collaborator
Meyer Children's Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wardle J, Beales S. Restraint, body image and food attitudes in children from 12 to 18 years. Appetite. 1986 Sep;7(3):209-17. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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).
Primary 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 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
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