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
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change from baseline in parental quality of life at one week after the intervention
研究概览
简要总结
The current study aims to develop a theoretically driven ACT intervention and examine its effects among parents of children with cancer. The objectives are:
- 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.
- To examine the effects of ACT intervention on parental negative experience, experiential avoidance and psychological flexibility in parents of children with cancer.
- To examine the effects of ACT intervention on psychological adjustment of children with cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The parents will be recruited if parent-child dyads fulfill the following eligibility criteria
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ACT intervention (Behavioral)
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.
干预措施: Usual care (Other)
结局指标
主要结局
Change from baseline in parental quality of life at one week after the intervention
时间窗: Baseline and 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)
Change from baseline in parental quality of life at three months after the intervention
时间窗: Baseline and 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)
Change from baseline in parental distress at one week after the intervention
时间窗: Baseline and 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)
Change from baseline in parental distress at three months after the intervention
时间窗: Baseline and 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)
次要结局
- 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)
- Change from baseline in parental psychological flexibility at three months after the intervention(Baseline and three months after the intervention)
- Change from baseline in psychological adjustment of children with cancer one week after the intervention(Baseline and one week after the intervention)
- Change from baseline in psychological adjustment of children with cancer at three months after the intervention(Baseline and three months after the intervention)
- Change from baseline in parental psychological experience of child Illness at one week after the intervention(Baseline and one week after the intervention)
研究者
Xiaohuan Jin
Principal Investigator
Chinese University of Hong Kong