Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03430752
Other study ID # UW 17-331 (2)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2017
Est. completion date August 31, 2018

Study information

Verified date June 2019
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood solid tumors.


Description:

In general, cancer can be divided into two main categories: blood cancer and solid tumors. Leukemia refer to the cancers in blood while solid tumors refer to the cancers which involve the formation of an abnormal mass without any liquid or cysts. Patients suffer from leukemia are usually have better prognosis which result in better psychological well-being when compared with those suffer from solid tumors (Rodin et al., 2010). The development of solid tumors in children is different from that in adult. Some of the solid tumors such as osteosarcoma, neuroblastoma, rhabdomyosarcoma, Wilms' tumor and retinoblastoma are exclusively found in children. Other types of solid tumors such as brain tumor can also be found in children.

Yet, most of recent studies in Hong Kong have focused in general childhood cancer survivors or their family members but no study has been conducted to focus on the physical and psychological well-being of survivors of childhood solid tumors (Li, Lopez, Chung, Ho, & Chiu, 2013; Wills, 2009). Therefore, the quality of life and psychological well-being of solid tumors survivors are always be overestimated. The actual psychological needs of solid tumors survivors may be overlooked. There is thus an imperative need to investigate the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood solid tumors.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 19 Years
Eligibility Inclusion Criteria:

- (1) Hong Kong Chinese under the age of 30 years at the time of study participation;

- (2) diagnosed with solid tumors or hematological malignancies under the age of 19 years;

- (3) completed the entire course of treatment for at least 6 months;

- (4) able to speak fluent Cantonese and read Chinese.

Exclusion Criteria:

- Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment will be excluded from this study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaires
Participants were asked to respond to the questionnaires including the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10).

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life at baseline The Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) consists of 23 items which are designed to measure the quality of life in four particular domains including physical ability, psychological states, social relationships and school functioning. PedsQL 4.0 is a five-point Likert scale for patients to response regarding to the experience over the last month. Higher scores represent better quality of life. Participants will be asked to respond to the Pediatric Quality-of-Life Inventory 4.0 Generic core sales (PedsQL 4.0) at baseline. Baseline
Secondary Levels of self-esteem at baseline The self-esteem of the participants will be measured by the Chinese version of the Rosenberg Self-esteem Scale (RSES). RSES consists of 10 items with a four-point response Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) and the total scores is ranging from 10 to 40. Higher scores represent higher levels of self-esteem. Participants will be asked to respond to the Chinese version of the Rosenberg Self-esteem Scale (RSES) at baseline. Baseline
Secondary Number of depressive symptoms at baseline The number of depressive symptoms of the participants will be measured by the Center for Epidemiological Studies - Depression Scale for children (CES-DC). It is able to assess the numbers of depressive symptoms due to the experience of past week. The scale consists of 20 items with four-point Likert scale for patients to response and the total score is ranging from 0 to 60. Higher scores represent greater numbers of depressive symptoms while lower scores represent fewer numbers of depressive symptoms. Participants will be asked to respond to the Center for Epidemiological Studies - Depression Scale for children (CES-DC) at baseline. Baseline
Secondary Level of sense of hope at baseline The sense of hope of the participants will be measured by the Chinese version of Herth Hope Index (HHI). It is a 12-item psychometric scale to measure the sense of hope. Each item contains four-point scale ("strong disagree" = "1", "disagree" = "2", "agree" = "3", "strong agree" = "4"). The total score of the 12 items ranging from 12 to 48 and higher scores imply increasing hopefulness. Participants will be asked to respond to the Chinese version of the Herth Hope Index (HHI) at baseline. Baseline
Secondary Resilience ability at baseline Resilience Scale for Children (RS10) is a 10-item scale to assess the adjustment ability for adapting adverse conditions such as cancer. The scale consists of 10 items with four-point Likert scale ("not at all like me"= "1", "not much like me" = "2", "somewhat like me" = "3", "a lot like me" = "4"). The total score is ranging from 10 to 40 which higher scores represent higher level of resilience. Participants will be asked to respond to the Chinese version of the Resilience Scale for Children (RS10) at baseline. Baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03336931 - PRecISion Medicine for Children With Cancer
Recruiting NCT01620372 - French Childhood Cancer Survivor Study N/A
Active, not recruiting NCT03585465 - Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06208657 - Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer Phase 1/Phase 2
Recruiting NCT01919866 - Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells Phase 1/Phase 2
Terminated NCT01337544 - Haploidentical Stem Cell Transplantation and IL-15 NK Cell Infusion for Paediatric Refractory Solid Tumours Phase 1/Phase 2
Completed NCT02533895 - Cancer Immune Therapy for the Treatment of Refractory Solid Tumours of Childhood Phase 1
Active, not recruiting NCT03445858 - Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults Early Phase 1
Recruiting NCT05504772 - Precision Medicine for Every Child With Cancer
Terminated NCT02624388 - Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) Phase 2
Completed NCT01670175 - Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors Phase 1
Completed NCT03206021 - COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors Phase 1