NCT04043117

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 17, 2025

Status Verified

October 1, 2024

Enrollment Period

4.9 years

First QC Date

July 31, 2019

Last Update Submit

February 14, 2025

Conditions

Keywords

Dimorphismself-esteemoncological treatments

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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

Study Arms (1)

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).

Other: Body Image evaluationOther: Self esteem evaluation

Interventions

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.

Clinical Group

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.

Clinical Group

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyer Children's Hospital

Florence, Florence, 50139, Italy

Location

Related Publications (7)

  • 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.

    PMID: 11948650BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 9019046BACKGROUND
  • 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.

    PMID: 30574405BACKGROUND
  • 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.

    PMID: 8932558BACKGROUND
  • 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.

    PMID: 12856818BACKGROUND
  • 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.

    PMID: 3800362BACKGROUND

Study Officials

  • Rosanna Martin, MSc

    Head of Pediatric Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

September 15, 2017

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

February 17, 2025

Record last verified: 2024-10

Locations