Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
14 participants
OBSERVATIONAL
2017-09-15
2022-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors
NCT06046014
Body Image Issues in Boys Being Treated at the Royal Marsden
NCT01876277
Fit to Fight Childhood Cancer
NCT05867186
Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology
NCT02541162
Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer
NCT04244955
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adequate knowledge of the Italian language
* Consent to participation
* First diagnosis for oncological pathology of leukaemia or bone cancer
Exclusion Criteria
* 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
12 Years
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meyer Children's Hospital IRCCS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rosanna Martin
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rosanna Martin, MSc
Role: PRINCIPAL_INVESTIGATOR
Head of Pediatric Psychology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Meyer Children's Hospital
Florence, Florence, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dimorphism and Self-esteem
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.