Brother or sister of a child has malignant haemopathy and follow-up in the pediatric hematology department

semi-structured interview conducted by a clinical psychologist

semi-directive interview

Eva De Berranger, MD

The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille

Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.

Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy.

Assessment of the level of satisfaction with the information received. The information will be characterized according to three dimensions: the framework (by whom, with whom, where, when, how) and the content of the information

The representation of the disease is the set of personal beliefs of an individual about the disease. It allows him to make sense of the disease. These data will be analyzed during the semi-structured interview

information and support needs gathered during the semi-structured interview

to identify during the semi-directive interview the elements informing about the social behavior and the psychic state of the subject included, expressed spontaneously by the subject, directly (in the speech, for example "I am sad") or indirectly (by attitude, for example: crying)

University Hospital, Lille

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Siblings (age \>40 and \<70) of individuals diagnosed with advanced neoplasm on screening colonoscopy. Advanced neoplasm is defined as adenomas≥10mm size, \>25% villous features, severe dysplasia or carcinoma-in-situ

Siblings (age \>40 and \<70) of individuals diagnosed with no polyp on screening colonoscopy who is age and sex matched to case.

Siew C Ng, PhD

BingYee Suen, BHSc

James Lau, MD

Justin C Wu, MD

James Y Lau, MD

Joseph J Sung, MD

To prospectively determine the prevalence of colorectal neoplasia in siblings of Hong Kong Chinese patients with advanced neoplasm compared with a sex and age-matched control population. To determine the molecular alteration profiles of colonic adenomas in siblings of patients with advanced neoplasm

The incidence of colorectal cancer (CRC) is rising rapidly in Hong Kong. It is the second commonest cancer in Hong Kong with more than 4000 new cases diagnosed in 2007, and it is also the second commonest cause of cancer death accounting for approximately 1,700 deaths per year. It has been estimated that 1 in 20 (5%) and 1 in 33 (3%) Hong Kong males and females, respectively, will develop CRC in their life time. (1) Data from the Hong Kong cancer registry showed that almost half of the cancer cases were stage III or IV disease at diagnosis which was associated with a worse prognosis(1), suggesting that earlier detection of CRC is important.

Genetic factors play an important role in the development of CRC. Approximately one fifth of CRC are associated with familial clustering(2), whilst hereditary syndromes including hereditary non- polyposis colorectal cancer (HNPCC) and familial adenomatous polyposis (FAP) account for approximately six percent of CRC cases (3;4)

Individuals with a family history of CRC have an increased risk of developing colonic neoplasm (cancer and adenoma). Meta-analyses of epidemiological studies showed that FDR of patients with CRC have an approximately two to three-fold increase risk of developing CRC compared with the general population (5-9). \[Table 1\]. The frequency of adenomas (12-69%) is also higher in relatives of patients with CRC although most of the earlier data have been derived from cohort studies (10-16). In the recent two case-control studies, the choice of the control population has been questionable (17;18) \[Table 2\]. Our own case-control study of screening colonoscopy in FDR with CRC, compared with FDR of patients with a normal colonoscopy ( published in abstract form) showed that the prevalence of colonic adenomas was significantly higher in cases compared with controls (25.3% versus 15.6%) (19).

Colorectal adenomas are precursors of CRC, and FDR of individuals with colonic adenomas also have an increased risk of CRC as well as colonic adenomas (20;21) The risk of developing colorectal neoplasia in FDR of patients with adenoma is likely be influenced by the characteristics of the adenoma in the index case. Colonic adenomas have a higher malignancy potential when they are greater than 10mm in size, and / or contains a villous component or severe dysplasia (22). In one study, relative risk of CRC for FDR was higher in relatives of patients with large adenomas (\>10mm) than in those with small adenomas (OR 2.1 and 1.2 respectively) (23). These findings have been reproduced in a recent study from France, which in addition showed that the risk was particularly high if the index case was younger than 60 years at diagnosis of a large adenoma, male or if they had a large adenoma in the left colon (24). In a separate study, relatives of patients with advanced neoplasm (OR1.62), but not those with small tubular adenomas (OR 1.26), have an increased risk of CRC (25).

Little is known about the prevalence of CRC and adenomas among siblings of individuals with advanced neoplasm in Hong Kong. Furthermore screening procedure for relatives of patients with high risk adenomas are not as well established as screening strategies for relatives of patients with CRC. This information is of important relevance in the formulation of an effective CRC screening strategy in Hong Kong (26). In a pilot screening project in 2001 among asymptomatic subjects of greater than 50 years old, the investigator have demonstrated an approximately 12% rate of advanced neoplasms using colonoscopy as a tool. Since 2008, asymptomatic subjects greater than 50 years old have been invited to undergo colonoscopy screening for CRC in PWH and AHNH hospital. To date about 1800 asymptomatic subjects have completed colonoscopy screening. This project provides the investigators with the opportunity to use an original design to determine the prevalence of colorectal neoplasia in siblings of patients with advanced neoplasm, compared with siblings of asymptomatic individuals who have had a negative screening colonoscopy during the same period of time.

The molecular pathways leading to tumour development in familial colorectal neoplasms are likely to be different from sporadic cases. Development of new molecular based methods for early detection, prevention or treatment relies heavily on the understanding of the differences between sporadic and familial neoplasms. Identification of genetic mutations can also improve genetic diagnosis and screening protocol of an at risk population.

The investigators hypothesize that siblings of patients with advanced neoplasm have an increased risk of both CRC and adenomas. The investigator aim to quantify this risk, and to identify other individual patient or neoplasm characteristics that may contribute to this increased risk. In addition, the investigator aim to determine molecular alteration profiles of colonic adenoma in siblings of patients with advanced neoplasm.

Investigator's preliminary data showed that the rate of advanced adenomas in controls (siblings of with normal colonoscopy) was 2%. Earlier studies have shown that the odds ratio of having colorectal neoplasms in close relatives of subjects with adenomas varies from 2.5 to 4.7. Using a conservative calculation, we assume that the prevalence of advanced adenomas in controls to be 3% and we estimate a 2.5-fold increased risk of advanced adenomas in siblings of individuals with advanced adenomas. Accordingly the recruitment of a minimum of 293 cases and 586 controls will be required to achieve 80% power to detect difference at a 5% significance level. For this project, investigators will aim to screen 300 siblings of patients with advanced adenomas and 600 matched controls.

A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study)

With informed consents, experienced colonoscopists will perform colonoscopy under intravenous sedation During colonoscopic examination, endoscopists are instructed to remove all raised lesions. The size, location and morphologic feature of each raised lesion will be recorded. The size is measured again an open biopsy forceps (6mm apart). To avoid observer bias, colonoscopists and pathologists will be blinded from patient's details regarding family history of CRC or advanced neoplasms. Our group performed the first screening study among average risk Hong Kong Chinese in the locality (28)

Chinese University of Hong Kong

Professor of Medicine

Behavioural: Participants in this arm will experience an 8-week manualized intervention program with activities and games. Sessions will NOT be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will NOT have a specific focus. Sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

Behavioural: Participants in this arm will experience an 8-week manualized intervention program which focuses on education, therapeutic problem solving, and social support. Each intervention session is structured by theme relevant to the cancer experience and themes are addressed through fun activities, games, arts, and crafts.To maximize the therapeutic effect of the intervention fun work (homework) will be assigned after each session. Training for the EG facilitators requires reading and studying the manual to become fully familiarized with the intervention approaches, observing group sessions through a one-way mirror prior to participation as a group facilitator, and participating as a group facilitator assistant for the intervention program.

Sessions will not be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.

Control Group

The experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope.

Experimental Group

Maru Barrera, PhD

The psychosocial effects of childhood cancer and its demanding medical treatment can affect not only the ill child but the whole family, particularly siblings who are often overlooked given the terrible circumstances these families face. Current evidence suggests that negative long-term psychosocial effects of childhood cancer may be more severe in siblings than in the child with cancer. Addressing these effects on siblings may benefit the child with cancer and the entire family. Thus, early psychosocial preventive interventions are needed to foster psychosocial adjustment in siblings and promote better quality of life for the entire family. The immediate objective of this study is to address siblings' psychological distress by assessing feasibility and efficacy of a manualized group intervention for siblings of children with cancer (Siblings Coping Together, SibCT). A longer term objective is that the evidence-based intervention could then be exported to other centres across Canada and internationally. Additionally, the study results will identify biomedical, personal, familial and social determinants of intervention outcomes that can guide clinical effort for those at greatest risk. Finally, the overall aim of the project is to reduce psychological distress and improve quality of life for siblings and families impacted by a cancer diagnosis and its demanding treatment.

Siblings of children with cancer can endure great psychological distress as a result of their brother's or sister's diagnosis and treatment. Understandably, when a child has cancer, their parents' attention is focused mainly on that child and therefore the siblings' needs may not be fully addressed. Thus, siblings often develop feelings of anger, abandonment, jealousy, and fear, which may lead to an increased risk for academic difficulties, symptoms of depression and anxiety and post traumatic stress disorder, although the results are not consistent across studies. Of most concern is that psychological problems may persist through adulthood, as suggested by a recent study in which alcoholism was more prevalent among siblings of children with cancer when compared to peers and cancer survivors. Therefore, it is imperative to develop evidence based psychological intervention programs to prevent these detrimental psychological effects in siblings of children with cancer. This project aims to address siblings' psychological distress by assessing the efficacy of a manualized group intervention for siblings of children with cancer (SibCT) across three Canadian sites (SickKids, Alberta Children's Hospital, BC Women and Children's Hospital) using a randomized control trial (RCT) experimental design. A manualized intervention is considered the gold standard for psychological intervention as it ensures replicability of the study and intervention fidelity. The primary aim is to demonstrate that survivors in the SibCT group (EG) demonstrate decreased symptoms of depression and anxiety improve their overall quality of life compared to an attention control group (CG). A secondary aim is to show that compared to CG, EG will show improvements in secondary measures of quality of life as well as knowledge about cancer. We will also explore other factors such as disease and treatment variables, social contextual variables, individual (sibling) variables and family variables. Randomized Control Trial design with repeated measures will be used. Siblings of children on active cancer treatment and at least 3 months from diagnosis to reduce parental burden; between 8-16 years of age will be included in the study. Siblings will be randomized to either the EG or CG. Approximately 184 siblings will be recruited across the three pediatric centres. After baseline assessment, both groups will have 8 two-hour weekly group sessions consisting of arts and crafts and games, and two post-intervention assessments; at the end of session 8 and three months later. In the EG the critical ingredient has education and social and therapeutic problem solving components based on the manual. Examples of weekly session topics include: age-appropriate medical information about cancer; siblings' fears and feelings; relationships at school, etc. The CG will not have any education or therapeutic-based components. Rigorous testing of the efficacy of an intervention program is a critical step for developing evidence-based treatments.

Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer

Multidimensional Anxiety Questionnaire, (MAQ) (Reynolds, 1999). MAQ consists of 40 items.

Perceived social support will be assessed as a potential social determinant of siblings' outcomes, using the Social Support Scale for Children (SSSC) (Harter, 1985). This scale has 24 items assessing 8 to 17-year-old children's perceptions of social support from others, including parents, teachers, classmates, and close friends.

Measured by Childhood Depression Inventory (CDI) \[Kovacs, 1992\]. ). This self-rated, 27-item scale was designed for children between the ages of 7-17.

Measured by State Trait Anxiety Inventory for Children (STAIC)( Spielberger, 1983). This is a 20-item self-report measure

Siblings Perception Questionnaire (SPQ) (Barbarin, 1995) is a 17-item questionnaire specifically designed for siblings of children with cancer

Pediatric Quality of Life Inventory (PedsQL 4.0 Varni, 1999) is a 23-item, standardized generic measure of health related QOL. The PedsQL, self-report and parent proxy, is composed of four subscales: Physical, Social, Emotional and School Functioning and a Total score.

The Hospital for Sick Children

Psychologist

Psychoeducation, provision of medical knowledge, coping skills training

Brief psychological intervention

Markus A Landolt, PhD

The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.

Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.	NCT03541330	Malignant Haemo...	semi-directive ...	6 Years - 12 Years	University Hospital, Lille
Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.	NCT03541330	Malignant Haemo...	semi-directive ...	6 Years - 12 Years	University Hospital, Lille
A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study)	NCT01593098	Adenoma CRC		40 Years - 70 Years	Chinese University of Hong Kong
Assessing the Efficacy of a Psychosocial Intervention Program for Siblings of Children With Cancer	NCT02787330	Cancer	Control Group Experimental Gr...	8 Years - 16 Years	The Hospital for Sick Children
Psychological Interventions in Siblings of Children With Cancer	NCT00296907	Cancer	Brief psycholog...	7 Years - 16 Years	University Children's Hospital, Zurich

Spots Global Cancer Trial Database for siblings

Every month we try and update this database with for siblings cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for siblings

Every month we try and update this database with for siblings cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for siblings cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.