## Protocol Section
### Identification Module
**NCT ID:** NCT05355779

**Brief Title:** Needs Assessment to Guide the Development of a Paediatric Survivorship Programme in Hong Kong

**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

#### Organization Study ID Info
**ID:** HKCH-REC-2021-056
#### Organization
**Class:** OTHER
**Full Name:** The Hong Kong Polytechnic University
### Status Module
#### Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-08-01

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2022-05-02
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-24
**Study First Submit QC Date:** 2022-04-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Health and Medical Research Fund

#### Lead Sponsor

**Class:** OTHER

**Name:** The Hong Kong Polytechnic University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Pediatric Cancer

- Survivorship

**Keywords:**

- Paediatric Cancer

- Survivorship

- Post-treatment

- Transition period

- Qualitative study

- Rehabilitation

- Needs

- Preferences

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Other: Not Application as this is a qualitative study

**Label:** Interviewees

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interviewees

**Description:** Not Application as this is a qualitative study

**Name:** Not Application as this is a qualitative study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Semi-structured and open-ended questions will be used to collect qualitative data from the participants

**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

**Description:** Semi-structured and open-ended questions will be used to collect qualitative data from the participants

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 18 Years

**Minimum Age:** 9 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Paediatric cancer survivors

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** The Hong Kong Children's Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Hong Kong Polytechnic University

**Name:** Joyce Chung

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
