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CompletedNCT03430752Updated Jun 28, 2019

Comparing the Impact of Cancer on Quality of Life Between Survivors of Childhood Solid Tumors and Leukemia

An observational study in Childhood Solid Tumor, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 6 Years to 19 Years. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by The University of Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
135
Ages
6 Years to 19 Years
Sex
All
01

Study 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.

Read the detailed 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.

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Conditions studied

  • Childhood Solid Tumor
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Who can participate

Ages eligible
6 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hong Kong Chinese under the age of 19 years who completed the entire course of treatment at least 6 months and were diagnosed with childhood solid tumors or leukemia under the age of 19 years.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
135 participants (actual)
Patient registry
No

Groups and cohorts

  • Survivors of Childhood Solid Tumors

    Survivors of Childhood Solid Tumors were invited to fill in a set of questionnaires.

    Other: questionnaires

  • Survivors of Childhood Leukemia

    Survivors of Childhood Leukemia were invited to fill in a set of questionnaires.

    Other: questionnaires

Interventions

  • Otherquestionnaires

    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).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

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Study locations

1 site
  • The University of Hong Kong
    Hong Kong, Hong Kong
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03430752
Lead sponsor
The University of Hong Kong
Responsible party
Sponsor
First posted
Feb 13, 2018
Start date
Sep 5, 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Jun 28, 2019

Study contacts

Ho Cheung William Li
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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