NCT05639062

Brief Summary

Cancer as a life-threatening disease can trigger children's unique spiritual needs. Unmet spiritual needs can cause low level of spiritual well-being, which is a central component for the overall quality of life (QoL) of cancer patients and was inversely associated with depressive symptoms, anxiety and a low level of hope. However, there has been no intervention focused on improving spiritual well-being among childhood cancer patients. Evidence from adult cancer patients suggests that narrative intervention can effectively address spiritual needs and improve spiritual well-being, while playing card game can combine an emotionally sensitive topic with an enjoyable activity, providing insight into the development of narrative-based card games for childhood cancer patients. The first objective of this pilot study is to assess the feasibility of narrative-based card game among Chinese childhood cancer patients. The second objective is to evaluate the preliminary effects of narrative-based card game intervention on spiritual well-being, hope, anxiety, depressive symptoms, and QoL of childhood cancer patients at postintervention and at 1-, and 3-month follow-up postintervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 7, 2022

Last Update Submit

November 24, 2022

Conditions

Pediatric Cancer

Keywords

spiritual well-beinginterventionchildhood cancer patients

Outcome Measures

Primary Outcomes (9)

  • The length of recruitment

    The time used for subject recruitment

    baseline

  • Eligibility rate

    The number of eligible childhood cancer patients divided by the number of childhood cancer patients screened prior to eligibility assessment

    baseline

  • Consent rate

    The number of eligible childhood cancer patients who agree to participate divided by the number of eligible childhood cancer patients

    baseline

  • Randomization rate

    The number of participants who are randomized divided by the number of consenting children

    baseline

  • Attendance rate

    The number of participants in the experimental group who complete the intervention divided by the number of participants randomized into the group

    post-intervention

  • Retention rate

    The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated at baseline and follow ups.

    post-intervention, and 1-month, 3- month follow ups

  • Completion rate

    The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

    post-intervention, and 1-month, 3-month follow ups

  • Missing data

    The percentage of missing data.

    post-intervention, 1-month, 3- month follow ups

  • Adverse events

    Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline.

    post-intervention, 1-month, 3-month follow ups

Secondary Outcomes (1)

  • The Chinese version of adapted Functional Assessment of Chronic Illness Therapy Spiritual Well-being Scale at 3 months follow-up

    at 3-months follow-up

Study Arms (2)

Narrative-based card game

ACTIVE COMPARATOR
Behavioral: Narrative-based card game

PUKE card game

NO INTERVENTION

Interventions

Narrative-based card gameBEHAVIORAL

This intervention aims to evaluate the preliminary effects of narrative-based card game intervention on spiritual well-being, hope, anxiety, depressive symptoms, and QoL of childhood cancer patients at postintervention and at 1-, and 3-month follow-up postintervention.

Narrative-based card game

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hong Kong, 0000, Hong Kong

Location

Related Publications (1)

  • Liu Q, Ho KY, Lam KKW, Wong FKY, Lam W, Cheng F, Wei H, Chan K, Ting M, Yang FN, Xiao P, Luo T, Wang HX, Yorke J. Preliminary effectiveness and feasibility of an integrated hope techniques and narrative-based card game intervention for pediatric cancer patients in China: a randomized controlled trial. BMC Med. 2025 Jul 31;23(1):449. doi: 10.1186/s12916-025-04287-5.

    PMID: 40745312DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

December 6, 2022

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

December 6, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)