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Trial record 10 of 125 for:    Recruiting, Not yet recruiting, Available Studies | "Osteosarcoma"

The Impact of Cancer on the Physical and Psychosocial Well-being Among Childhood Osteosarcoma Survivors

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ClinicalTrials.gov Identifier: NCT03298971
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief 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 osteosarcoma.

Condition or disease Intervention/treatment
Childhood Osteosarcoma Other: Questionnaires

Detailed Description:
Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. The 5-year overall survival rates of childhood osteosarcoma survivors have been increasing substantially with a percentage approaching to 70%. Regrettably, the improved survival rates may lead to long-term sequelae related to disease and treatments that can negatively affect survivors' physical and psychological well-being. Despite numerous studies have examined the impact of cancer and treatment-related late effects on the physical and psychological aspects of osteosarcoma survivors in the foreign countries, it has not been studied specifically in Hong Kong Chinese population. Problems arise when there is a difference in perception and recognition of psychological problems and emotional well-being between Western and Chinese culture. Moreover, the difference in coping strategies between Chinese and Western children also affects how they react and cope with the devastating effect from cancer and its treatments. Due to the cultural and belief differences, the findings from those studies in the foreign counties may not be applicable and transferable in Hong Kong context. 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 osteosarcoma in order to raise awareness of the holistic wellness of osteosarcoma survivors.

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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 Osteosarcoma: An Exploratory Study
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Survivors of Childhood Osteosarcoma
Survivors of Childhood Osteosarcoma were invited to fill in a set of questionnaires.
Other: Questionnaires
Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).

Healthy Subjects
Healthy Subjects were invited to fill in a set of questionnaires.
Other: Questionnaires
Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).




Primary Outcome Measures :
  1. Levels of quality of life at baseline [ Time Frame: baseline ]
    The quality of life of the participants will be measured by the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)). It consists of 28 items with a five-point response Likert scale. There are two questions to access the overall perception of quality of life and health respectively. The remaining 26 items were designed to assess the perception of quality of life in four particular domains including physical health, psychological well-being, social relationships and environments. Higher scores represent higher levels of QoL. Participants will be asked to respond to the Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)) at baseline.


Secondary Outcome Measures :
  1. Levels of self-esteem at baseline [ Time Frame: 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.

  2. Number of depressive symptoms at baseline [ Time Frame: baseline ]
    The number of depressive symptoms of the participants will be measured by the Center for Epidemiological Studies - Depression Scale (CES-D). 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 (CES-D) at baseline.

  3. Level of sense of hope at baseline [ Time Frame: 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.



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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hong Kong Chinese under the age of 30 years who completed the entire course of treatment at least 5 years and were diagnosed with osteosarcoma under the age of 19 years.
Criteria

Inclusion Criteria:

  • Hong Kong Chinese under the age of 30 years at the time of study participation;
  • Diagnosed with osteosarcoma under the age of 19 years;
  • Completed the entire course of treatment at least 5 years;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298971


Contacts
Contact: Ho Cheung William Li 39176634 william3@hku.hk
Contact: Long Kwan Ho 39176643 longkwan@hku.hk

Locations
Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Ho Cheung William Li, PhD    39176634    william3@hku.hk   
Principal Investigator: Ho Cheung William Li, PhD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ho Cheung William Li The University of Hong Kong

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03298971     History of Changes
Other Study ID Numbers: UW 17-331
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma