Clinical trial NCT04870697: Acceptance and Commitment Therapy for Parents of Children With Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Cancer
Keywords: parents
Acceptance and Commitment Therapy
psychological flexibility
psychological distress
quality of life
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in parental quality of life at one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in parental quality of life at three months after the intervention
timeFrame: Baseline and three months after the intervention
measure: Change from baseline in parental distress at one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in parental distress at three months after the intervention
timeFrame: Baseline and three months after the intervention
Secondary outcomes:
measure: Change from baseline in parental psychological experience of child Illness at one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in parental psychological experience of child Illness at three months after the intervention
timeFrame: Baseline and three months after the intervention
measure: Change from baseline in parental experiential avoidance at one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in parental experiential avoidance at three months after the intervention
timeFrame: Baseline and three months after the intervention
measure: Change from baseline in parental psychological flexibility at one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in parental psychological flexibility at three months after the intervention
timeFrame: Baseline and three months after the intervention
measure: Change from baseline in psychological adjustment of children with cancer one week after the intervention
timeFrame: Baseline and one week after the intervention
measure: Change from baseline in psychological adjustment of children with cancer at three months after the intervention
timeFrame: Baseline and three months after the intervention
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
Study officials:
affiliation: Chinese University of Hong Kong
name: Cho Lee Wong, PhD
role: STUDY_DIRECTOR
References: