Pediatric CancerNCT05355779
Needs Assessment to Guide the Development of a Paediatric Survivorship Programme in Hong Kong
An observational study of Pediatric Cancer and Survivorship, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study aims to fill the gaps in knowledge regarding the effects of cancer and its treatment on Hong Kong Chinese paediatric cancer survivors, especially during the transition period, to further capture a deeper understanding of the challenges, views and needs of Hong Kong Chinese paediatric cancer survivors and… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Pediatric Cancer, Survivorship
- What is being tested?
- Not Application as this is a qualitative study
- How many people
- 38 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric cancer survivors
Who may be able to join
- able to speak Cantonese and read Chinese
- aged between 9 and 18 years of age
- Should have completed cancer treatment between 2 months and 2 years earlier
Who cannot join
- Children who received a diagnosis and completed treatment before the age of 9 will be excluded as they might have vague memories of the course of cancer and may have limited verbal and cognitive ability to express themselves
- Children of exclude parents will be exclueded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needs Assessment to Guide the Development of a Paediatric Survivorship Programme in Hong Kong to Promote Physical and Psychological Well-being of Children After Cancer Treatment
This study aims to fill the gaps in knowledge regarding the effects of cancer and its treatment on Hong Kong Chinese paediatric cancer survivors, especially during the transition period, to further capture a deeper understanding of the challenges, views and needs of Hong Kong Chinese paediatric cancer survivors and the key stakeholders around them via face-to-face conversations.
Read the detailed description
Objectives: Although increasing attention has been devoted to the development of paediatric cancer survivorship programmes, most of these studies have originated in Western countries. Given the cultural differences between Asian and Western communities, the applicability of the findings to paediatric cancer survivors in Asian cultural contexts is limited. To date, research remains scant regarding the needs and challenges of Hong Kong Chinese paediatric cancer survivors and the key stakeholders involved during the transition period after cancer treatment. Although Hong Kong paediatric cancer survivors do attend regular medical follow-up visits, most attention has been focused on their physiological care, while their psychosocial needs remain unmet. Accordingly, the aim of this proposed study will be to fill the gaps in knowledge regarding the effects of cancer and its treatment, especially will focus on psychosocial effects in Hong Kong Chinese paediatric cancer survivors during the transition period.
Design and subjects: A qualitative descriptive design will be used. A purposive sample of 15 paediatric cancer survivor participants and their parents or caregivers, five paediatric oncology nurses and three paediatric oncologists will be invited for a semi-structured interview conducted with the aid of an interview guide.
Data analysis: A thematic analysis approach will be used for data analysis.
Expected results: The findings of this study will provide an in-depth understanding of the needs, challenges and views of paediatric cancer survivors and other key stakeholders, which will greatly facilitate the future development of appropriate targeted paediatric cancer survivorship programmes.
- Conditions
- Pediatric Cancer, Survivorship
- Being tested
- Not Application as this is a qualitative study
- Keywords
- Paediatric Cancer, Survivorship, Post-treatment, Transition period, Qualitative study, Rehabilitation, Needs, Preferences
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Application as this is a qualitative studyOther
Not Application as this is a qualitative study
| Study group | Role | What they receive |
|---|---|---|
| Interviewees | Paediatric cancer survivors, their parent/caregiver and health care professionals will be invited to express their views and perspectives in an interview with the researcher Receives: Other: Not Application as this is a qualitative study |
What is being measured
The primary outcome is the main question the study is designed to answer.
An individual, a face-to-face interview will be conducted with the participants to identify the needs of paediatric cancer survivors during the transition period after cancer treatment
Semi-structured and open-ended questions will be used to collect qualitative data from the participants
Measured: through study completion, an average of 15 months
An individual, a face-to-face interview will be conducted with the participants to assess the key elements in the development of a paediatric survivorship programme
Semi-structured and open-ended questions will be used to collect qualitative data from the participants
Measured: through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Sponsor
- Investigators
- Joyce Chung, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355779
- Sponsor's protocol ID
- HKCH-REC-2021-056
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment to Guide the Development of a Paediatric Survivorship Programme in Hong Kong to Promote Physical and Psychological Well-being of Children After Cancer Treatment
- ClinicalTrials.gov ID
- NCT05355779
- Acronym / sponsor ID
- HKCH-REC-2021-056
- Conditions
- Pediatric Cancer, Survivorship
- Keywords
- Paediatric Cancer, Survivorship, Post-treatment, Transition period, Qualitative study, Rehabilitation, Needs, Preferences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to fill the gaps in knowledge regarding the effects of cancer and its treatment on Hong Kong Chinese paediatric cancer survivors, especially during the transition period, to further capture a deeper understanding of the challenges, views and needs of Hong Kong Chinese paediatric cancer survivors and the key stakeholders around them via face-to-face conversations.
Detailed description
Objectives: Although increasing attention has been devoted to the development of paediatric cancer survivorship programmes, most of these studies have originated in Western countries. Given the cultural differences between Asian and Western communities, the applicability of the findings to paediatric cancer survivors in Asian cultural contexts is limited. To date, research remains scant regarding the needs and challenges of Hong Kong Chinese paediatric cancer survivors and the key stakeholders involved during the transition period after cancer treatment. Although Hong Kong paediatric cancer survivors do attend regular medical follow-up visits, most attention has been focused on their physiological care, while their psychosocial needs remain unmet. Accordingly, the aim of this proposed study will be to fill the gaps in knowledge regarding the effects of cancer and its treatment, especially will focus on psychosocial effects in Hong Kong Chinese paediatric cancer survivors during the transition period.
Design and subjects: A qualitative descriptive design will be used. A purposive sample of 15 paediatric cancer survivor participants and their parents or caregivers, five paediatric oncology nurses and three paediatric oncologists will be invited for a semi-structured interview conducted with the aid of an interview guide.
Data analysis: A thematic analysis approach will be used for data analysis.
Expected results: The findings of this study will provide an in-depth understanding of the needs, challenges and views of paediatric cancer survivors and other key stakeholders, which will greatly facilitate the future development of appropriate targeted paediatric cancer survivorship programmes.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interviewees | – | Other: Not Application as this is a qualitative studyPaediatric cancer survivors, their parent/caregiver and health care professionals will be invited to express their views and perspectives in an interview with the researcher |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric cancer survivors
Key inclusion criteria (3 listed)
- able to speak Cantonese and read Chinese
- aged between 9 and 18 years of age
- Should have completed cancer treatment between 2 months and 2 years earlier
Key exclusion criteria (2 listed)
- Children who received a diagnosis and completed treatment before the age of 9 will be excluded as they might have vague memories of the course of cancer and may have limited verbal and cognitive ability to express themselves
- Children of exclude parents will be exclueded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not Application as this is a qualitative studyNot Application as this is a qualitative study | Other | Interviewees |
Primary outcome
An individual, a face-to-face interview will be conducted with the participants to identify the needs of paediatric cancer survivors during the transition period after cancer treatment
Time frame: through study completion, an average of 15 months
Semi-structured and open-ended questions will be used to collect qualitative data from the participants
An individual, a face-to-face interview will be conducted with the participants to assess the key elements in the development of a paediatric survivorship programme
Time frame: through study completion, an average of 15 months
Semi-structured and open-ended questions will be used to collect qualitative data from the participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Chung principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Survivorship, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An individual, a face-to-face interview will be conducted with the participants to identify the needs of paediatric cancer survivors during the transition period after cancer treatment (time frame: through study completion, an average of 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.