Acceptance and Commitment Therapy for Parents of Children With Cancer — ACT  

Childhood Cancer Clinical Trial

Official title: Effects of Acceptance and Commitment Therapy on Promoting Parental Quality of Life and Reducing Psychological Distress in Parents of Children With Cancer: A Randomized Controlled Trial Protocol

Status Recruiting

Clinical Trial Summary

The current study aims to develop a theoretically driven ACT intervention and examine its effects among parents of children with cancer. The objectives are:

1. To examine the effects of ACT intervention on parental QOL and psychological distress (symptoms of anxiety, depression and stress) in parents of children with cancer.

2. To examine the effects of ACT intervention on parental negative experience, experiential avoidance and psychological flexibility in parents of children with cancer.

3. To examine the effects of ACT intervention on psychological adjustment of children with cancer.

Clinical Trial Description

A pilot study will be used to evaluate the feasibility and acceptability of ACT intervention protocol in Chinese parents of children with cancer. A two-arm parallel randomized controlled trial (RCT) will be used to evaluate the effects of ACT intervention in parents of children with cancer.

Eligible participants will be randomly assigned into a 1:1 allocation ratio to the ACT group or control group using block randomization with random mixture blocks of 4, 6 and 8. This can avoid the greater frequency of assignments to either group and lead to more balanced treatment groups in size and key outcome-related characteristics over time while reducing the predictability of assignment from the preceding assignment. A sequence list of two group labels (1 = ACT group, 2 = Control group) will be generated using a computerized generation randomization tool by an independent statistician who is blinded to the meaning of group labels will not involve the other part of the study. The group allocation assignment labels will be contained in opaque sealed envelopes and concealed to all researchers and participants involved in this study until the research investigator has completed the assessments of the participant and obtained written consent during the recruitment.

Considering the nature of the study, blinding of participants and ACT interventionists will be impossible. The research assistants involved in data collection and data entry as well as health routine care providers in the units of study hospital will be blinded to the group allocation.

To prevent possible contamination, the ACT intervention for parents in the ACT group will be conducted in a meeting room in the staff area which is geographically separate from the patient area. Besides, the participants are required not to show ACT intervention materials to, nor discuss the intervention contents with other parents in the unit. ;

Related Conditions & MeSH terms

• Childhood Cancer

• NCT number: NCT04870697
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Contact: Xiaohuan Jin
• Phone: (852)53019946
• Email: xiaohuanjin@lin.cuhk.edu.hk
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Completion date: January 2022