Acceptance and Commitment Therapy for Parents of Children With Cancer

NCT04870697 | Unknown

• 1 other identifier: CREC Ref. No 2020.452
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Conditions

Childhood Cancer

Keywords

parents; Acceptance and Commitment Therapy; psychological flexibility; psychological distress; quality of life

Outcome Measures

Primary Outcomes (4)

• Change from baseline in parental quality of life at one week after the intervention

  PedsQL Parent HRQL Scale is adopted to assess parental quality of life. PedsQL Parent HRQL Scale consists of 20 items with 4 subscales of physical functioning, emotional functioning, social functioning, and cognitive functioning. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). Higher scores indicate higher quality of life. Change = (One week after the intervention score - baseline score)

  Baseline and one week after the intervention

• Change from baseline in parental quality of life at three months after the intervention

  PedsQL Parent HRQL Scale is adopted to assess parental quality of life. PedsQL Parent HRQL Scale consists of 20 items with 4 subscales of physical functioning, emotional functioning, social functioning, and cognitive functioning. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). Higher scores indicate higher quality of life. Change = (Three months after the intervention score - baseline score)

  Baseline and three months after the intervention

• Change from baseline in parental distress at one week after the intervention

  Depression Anxiety Stress Scales-21 is adopted to assess the level of depression, anxiety and stress in parents with 21 items and 3 subscales. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (always). Higher scores indicate more severe symptoms of depression, anxiety, or stress. Change = (One week after the intervention score - baseline score)

  Baseline and one week after the intervention

• Change from baseline in parental distress at three months after the intervention

  Depression Anxiety Stress Scales-21 is adopted to assess the level of depression, anxiety and stress in parents with 21 items and 3 subscales. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (always). Higher scores indicate more severe symptoms of depression, anxiety, or stress. Change = (Three months after the intervention score - baseline score)

  Baseline and three months after the intervention

Secondary Outcomes (8)

• Change from baseline in parental psychological experience of child Illness at one week after the intervention

  Baseline and one week after the intervention

• Change from baseline in parental psychological experience of child Illness at three months after the intervention

  Baseline and three months after the intervention

• Change from baseline in parental experiential avoidance at one week after the intervention

  Baseline and one week after the intervention

• Change from baseline in parental experiential avoidance at three months after the intervention

  Baseline and three months after the intervention

• Change from baseline in parental psychological flexibility at one week after the intervention

  Baseline and one week after the intervention

Study Arms (2)

ACT group

EXPERIMENTAL

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.

Behavioral: ACT intervention

Control group

OTHER

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.

Other: Usual care

Interventions

ACT intervention BEHAVIORAL

The components of ACT intervention will include six processes to foster parental PF according to the ACT framework. Session one - Generate creative hopelessness and build acceptance. The objective is to help parents know about the ACT intervention and realize the experiential avoidance or emotional control strategies do not work, finally turn attention to more useful strategies. Session two - Create space for your thought. The objective is to help parents create a distance from their thoughts and facilitate parents' ability of not being trapped by thoughts. Session three - Focus on here and now. The objectives to facilitate parents' experiences of observing self and contact with the present moment but not trapped in the past or future. Session four - Commit actions in line with the value. The objectives to help parents identify their inner value and take value-based actions even facing the challenges in current difficulties of their children with cancer.

ACT group

Usual care OTHER

Usual care in this study setting includes providing general information, education, psychological support, and consultation.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Children's Hospital of Soochow University

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cho Lee Wong, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Xiaohuan Jin

CONTACT

(852)53019946; xiaohuanjin@lin.cuhk.edu.hk

Cho Lee Wong, PhD

CONTACT

(852) 3943 8166; jojowong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 3, 2021
• Study Start: June 28, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)