Childhood CancerACTNCT04870697
Acceptance and Commitment Therapy for Parents of Children With Cancer
A study testing ACT intervention in people with Childhood Cancer, run by Chinese University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- ACT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Soochow University
Suzhou
Wenying Yao, Bachelor
About this study
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
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.
Read the 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.
- Conditions
- Childhood Cancer
- Being tested
- ACT intervention, Usual care
- Keywords
- parents, Acceptance and Commitment Therapy, psychological flexibility, psychological distress, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT interventionBehavioural
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 careOther
Usual care in this study setting includes providing general information, education, psychological support, and consultation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Parent Experience of Child Illness is adopted to assess parental psychological experience of their children with cancer. The scale consists of 25 items with 4 subscales of 'guilt and worry', 'unresolved sorrow and anger', 'long-term uncertainty' and 'emotional resources'. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more difficulties in adjustment to their children with cancer.
Change = (One week after the intervention score - baseline score)
Measured: Baseline and one week after the intervention
Change from baseline in parental psychological experience of child Illness at three months after the intervention
Parent Experience of Child Illness is adopted to assess parental psychological experience of their children with cancer. The scale consists of 25 items with 4 subscales of 'guilt and worry', 'unresolved sorrow and anger', 'long-term uncertainty' and 'emotional resources'. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more difficulties in adjustment to their children with cancer.
Change = (Three months after the intervention score - baseline score)
Measured: Baseline and three months after the intervention
Change from baseline in parental experiential avoidance at one week after the intervention
Acceptance and Action Questionnaire-II is adopted to assess experiential avoidance of parents. AAQ-II consists of 7 items. Each item is rated on a 7-point Likert scale ranging from 1 (never) to 7 (always). A higher score indicates great experiential avoidance.
Change = (One week after the intervention score - baseline score)
Measured: Baseline and one week after the intervention
Change from baseline in parental experiential avoidance at three months after the intervention
Acceptance and Action Questionnaire-II is adopted to assess experiential avoidance of parents. AAQ-II consists of 7 items. Each item is rated on a 7-point Likert scale ranging from 1 (never) to 7 (always). A higher score indicates great experiential avoidance.
Change = (Three months after the intervention score - baseline score)
Measured: Baseline and three months after the intervention
Change from baseline in parental psychological flexibility at one week after the intervention
Comprehensive assessment of Acceptance and Commitment Therapy processes is adopted to assess psychological flexibility of parents. CompACT consists of 23 items to measure three dyadic processes of ACT on 'acceptance and defusion', 'present moment awareness' and 'self as values and committed action'. Each item is rated on a 7-point Likert scale ranging from 0 (never) to 6 (always). Higher scores indicate a lower level of PF.
Change = (One week after the intervention score - baseline score)
Measured: Baseline and one week after the intervention
Change from baseline in parental psychological flexibility at three months after the intervention
Comprehensive assessment of Acceptance and Commitment Therapy processes is adopted to assess psychological flexibility of parents. CompACT consists of 23 items to measure three dyadic processes of ACT on 'acceptance and defusion', 'present moment awareness' and 'self as values and committed action'. Each item is rated on a 7-point Likert scale ranging from 0 (never) to 6 (always). Higher scores indicate a lower level of PF.
Change = (Three months after the intervention score - baseline score)
Measured: Baseline and three months after the intervention
Change from baseline in psychological adjustment of children with cancer one week after the intervention
Strengths and Difficulties Questionnaire is adopted to assess the psychological adjustment of children ages 2 to 17 years old. SDQ consists of 25 items to measure the emotional symptoms and behavioural problems of children. Each item is rated on a 3-point Likert scale ranging from 0 (not true) to 2 (certainly true). A higher score indicates poor psychological adjustment.
Change = (One week after the intervention score - baseline score)
Measured: Baseline and one week after the intervention
Change from baseline in psychological adjustment of children with cancer at three months after the intervention
Strengths and Difficulties Questionnaire is adopted to assess the psychological adjustment of children ages 2 to 17 years old. SDQ consists of 25 items to measure the emotional symptoms and behavioural problems of children. Each item is rated on a 3-point Likert scale ranging from 0 (not true) to 2 (certainly true). A higher score indicates poor psychological adjustment.
Change = (Three months after the intervention score - baseline score)
Measured: Baseline and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start28 Jun 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohuan Jin, Chinese University of Hong Kong
- Investigators
- Cho Lee Wong, PhD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870697
- Sponsor's protocol ID
- CREC Ref. No 2020.452
- Acronym
- ACT
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04870697
- Acronym / sponsor ID
- ACT / CREC Ref. No 2020.452
- Conditions
- Childhood Cancer
- Keywords
- parents, Acceptance and Commitment Therapy, psychological flexibility, psychological distress, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT group | Experimental | Behavioral: ACT interventionIn 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. |
| Control group | Other | Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT interventionThe 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. | Behavioural | ACT group |
| Usual careUsual care in this study setting includes providing general information, education, psychological support, and consultation. | Other | Control group |
Primary outcome
Change from baseline in parental quality of life at one week after the intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
8 secondary outcomes
Change from baseline in parental psychological experience of child Illness at one week after the intervention
Time frame: Baseline and one week after the intervention
Change from baseline in parental psychological experience of child Illness at three months after the intervention
Time frame: Baseline and three months after the intervention
Change from baseline in parental experiential avoidance at one week after the intervention
Time frame: Baseline and one week after the intervention
Change from baseline in parental experiential avoidance at three months after the intervention
Time frame: Baseline and three months after the intervention
Change from baseline in parental psychological flexibility at one week after the intervention
Time frame: Baseline and one week after the intervention
Change from baseline in parental psychological flexibility at three months after the intervention
Time frame: Baseline and three months after the intervention
Change from baseline in psychological adjustment of children with cancer one week after the intervention
Time frame: Baseline and one week after the intervention
Change from baseline in psychological adjustment of children with cancer at three months after the intervention
Time frame: Baseline and three months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cho Lee Wong, PhD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT intervention in people with Childhood Cancer, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohuan Jin ((852)53019946, xiaohuanjin@lin.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in parental quality of life at one week after the intervention (time frame: Baseline and one week after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.