Acceptance and Commitment Therapy for Parents of Children With Cancer
NCT ID: NCT04870697
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
142 participants
INTERVENTIONAL
2021-06-28
2022-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ACT group
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.
ACT intervention
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.
Control group
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.
Usual care
Usual care in this study setting includes providing general information, education, psychological support, and consultation.
Interventions
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ACT intervention
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.
Usual care
Usual care in this study setting includes providing general information, education, psychological support, and consultation.
Eligibility Criteria
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Inclusion 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 children who are cognitive impaired
* Children in critical condition or palliative care
18 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Xiaohuan Jin
Principal Investigator
Principal Investigators
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Cho Lee Wong, PhD
Role: STUDY_DIRECTOR
Chinese University of Hong Kong
Locations
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Children's Hospital of Soochow University
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Wenying Yao, Bachelor
Role: primary
Other Identifiers
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CREC Ref. No 2020.452
Identifier Type: -
Identifier Source: org_study_id
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