Acceptance and Commitment Therapy for Parents of Children With Cancer (ACT)

The Chinese University of Hong Kong

Status: Unknown

Conditions: Childhood Cancer

Treatments: Other: Usual care; Behavioral: ACT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04870697

CREC Ref. No 2020.452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The parents will be recruited if parent-child dyads fulfill the following eligibility criteria

Parents:

• Over the ages of 18 years old
• Fathers or mothers who are the primary caregivers (provide the largest amount of daily care) of Children with cancer
• Living together with the childhood cancer patients
• Can communicate in Chinese and follow the instructions of the study
• Can be accessible by telephone or by email

Children:

• Between the ages of 2 to 17 years old
• Newly diagnosed of cancer by a physician in the previous six months and currently receive treatment

Exclusion criteria

• Parents or their child who were currently participating in another cancer-related intervention study
• Parents or their children who are cognitive impaired
• Children in critical condition or palliative care

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

ACT group

Experimental group

Description:

In addition to usual care, participants in the ACT group will receive ACT intervention. ACT intervention will be conducted in an individual-based format with four weekly sessions. The first session is a face-to-face format and the other three sessions are online live format.

Treatment:

Behavioral: ACT intervention

Control group

Other group

Description:

Participants in the control group will receive usual care in the study setting delivered by clinical staff. The rationale for adopting usual care as a control group is not only because it is more commonly used but also for practical and ethical considerations, as usual care is what is already being delivered clinically, therefore the results of the study can support any necessity of changes to clinical practice or not.

Treatment:

Other: Usual care