CancerNCT04132856
Mapping Psychosocial Screening to Services for Children With Cancer
A study testing Psychosocial Navigator and Communication of Summary Profile in people with Cancer, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Children with cancer are vulnerable to symptoms of anxiety and depression. Although screening for psychosocial distress is a standard of care for children with cancer, there is a limited knowledge Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Psychosocial Navigator and Communication of Summary Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2017to 30 Apr 2020
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between 10 and 18 years of age
- Clinical diagnosis of cancer
- Less than 4 weeks since diagnosis disclosure
- Primary caregiver must also consent to participation
Who cannot join
- Cancer diagnosis disclosed more than 4 weeks ago.
- Primary caregiver declines to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Psychosocial Screening to Services for Children With Cancer: Feasibility and Pilot Study
Children with cancer are vulnerable to symptoms of anxiety and depression. Although screening for psychosocial distress is a standard of care for children with cancer, there is a limited knowledge
Read the detailed description
Background: Approximately 3 000 children and adolescents are diagnosed with cancer in Canada each year [Canadian Cancer Society]. Children with cancer experience higher rates of anxiety and depression symptoms relative to healthy controls [Pinquart \& Shen, 2011], and a subgroup are vulnerable to marked levels of psychological distress [Kurtz \& Abrams, 2011]. One standard for psychosocial care in pediatric cancer that is starting to be implemented across the United Stated and Canada is the systematic screening for psychosocial distress, using the Psychosocial Assessment Tool (PAT) [Kazak, Schneider, Didonato, Pai, 2015; Pai et al., 2008; Barrera et al., 2014; McCarthy et al., 2009; Sint Nicolaas et al., 2016]. However, a dearth of literature exists on how to bridge screening for psychosocial distress and the delivery of appropriate evidence-based mental health resources. The current study is a randomized controlled pilot intervention project which aims to test the feasibility and effects of introducing a psychosocial navigator who will coordinate the delivery of psychosocial resources to children with cancer and their families based on early screening and follow-up for psychosocial distress. Specific Objectives: 1) To determine the feasibility and utility of conducting psychosocial screening and providing an Enhanced Psychosocial Intervention (EPSI). 2) To examine the effects of EPSI, as compared to treatment as usual (TAU+), on the mental health, quality of life, coping, and social relationships of children with cancer. Methods: A randomized controlled feasibility intervention trial, with a TAU+ control group, will be conducted with newly diagnosed children with any type of cancer. Participants will be 10-18 years of age, medically suitable for participation, in active treatment, and the primary caregiver. Forty-eight child-caregiver dyads (24 in the intervention and 24 in the control group) will be enrolled. The EPSI will have two components: 1) Information about the psychosocial risk of the family and mental health of the child (e.g., depression) and 2) the Psychosocial Navigator (PSN) as resource for tailoring psychosocial resources to child-family distress, linking with the treating team. Measures of feasibility (recruitment, acceptability) will be documented throughout; initial screening using the PAT will be conducted 2-4 weeks post diagnosis (baseline); and using the distress thermometer, follow-up will be done at specific periods depending on the disease (leukemia/lymphoma, solid tumors, brain tumors). The primary psychosocial outcome (depression), and secondary outcomes (post-traumatic stress, pain, fatigue, coping, sleep quality, time and financial cost, social support and quality of life) will be completed at baseline and 12 months later. Descriptive statistics (frequency and percentage rates) will be provided for feasibility measures and PAT psychosocial risk categories. Means, standard deviations, and ranges will be provided for the primary and secondary outcomes. Preliminary analyses of group comparisons will also be performed via independent t tests and chi square tests. Further, analyses of covariance (ANCOVAs) will be conducted on the primary and secondary outcomes to test group differences at post-test while controlling for pretest scores.
Significance: The proposed intervention project will assess and address the psychosocial needs of newly diagnosed pediatric cancer patients and families. This intervention aims to improve the triaging of resources and enhance the effectiveness of psychosocial intervention for children with cancer. The enhanced intervention is expected to improve children's and adolescents' coping with disease-related stressors such as pain and uncertainty, improve their mood, and enhance social engagement with peers.
- Conditions
- Cancer
- Being tested
- Psychosocial Navigator, Communication of Summary Profile
- Keywords
- pediatric, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial NavigatorOther
Services of psychosocial navigator
Communication of Summary ProfileOther
Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Intervention group will receive the services of the Psychosocial Navigator (PSN) monthly for the full 12 months of the study. At baseline, the PSN will provide the health care providers (HCPs) and family with recommendations for mapping and triaging of resources to levels of psychosocial risk (PAT: Universal, Targeted, Clinical) and level of depression and anxiety (mild, moderate, and high mental health problems; as determined by the standardized norms for the measures). This information will be summarized in the Communication Summary Profile and shared with the treating team (oncologist, nurse, and Social Worker, core psychosocial staff involved in the child's care) and family within 48 hours of completion. The PSN will conduct follow-up psychosocial screenings on a monthly basis, using the Distress Thermometer for children and caregivers. Results of the monthly assessments and recommended resources will also be communicated to the caregiver/parent and treating team of the youth. Receives: Other: Psychosocial Navigator; Other: Communication of Summary Profile |
| Treatment as Usual Group | No intervention | Current psychosocial care services will be accessible to Treatment as Usual Group (e.g., social work, child life, psychology, art and music therapy, and psychiatry). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility pertaining to recruitment
Rate of recruitment as measured by percentage of participants who consent to participation as compared to those who are eligible and do not consent
Measured: 12 months
Feasibility pertaining to retention
Rates of completed questionnaires at all time points
Measured: 12 months
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
5 - point likert scale satisfaction questionnaire with 6 questions pertaining to usefulness and overall satisfaction with the enhanced intervention. The minimum score is 6 (low satisfaction) and the maximum score is 30 (high satisfaction).
Measured: 12 months
Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study
Semi-structured interview with 6 questions including "What were your expectations about being in this study?"; "Were your expectations of the study met?"; "Do you have any additional comments/suggestions for the study?"
Measured: 12 months
Secondary outcomes (16)
Distress
Pediatric and Adult Distress Thermometer (self-report) measures participant distress on a visual analog scale of 1 to 10, with a score of 10 indicating high distress
Measured: Change from baseline to 12 months
Patient generic quality of life based on self report
Pediatric Quality of Life - generic. (Child/teen self-report). Measures perceived quality of life of child with cancer based on self perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Measured: Change from baseline to 12 months
Patient generic quality of life based on caregiver report
Pediatric Quality of Life - generic. (Caregiver-report). Measures perceived quality of life of child with cancer based on caregiver perception - on everyday items (for children who do not have cancer). Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Measured: Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on self-report
Pediatric Quality of Life-Cancer (Child/teen self-report). Measures perceived quality of life of child with cancer based on self-perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Measured: Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on caregiver report
Pediatric Quality of Life-Cancer (Caregiver report). Measures perceived quality of life of child with cancer based on caregiver perception. Miinimum score is 0. Maximum score is 100. Higher score indicates better perceived quality of life.
Measured: Change from baseline to 12 months
Patient anxiety and depression - child/teem self report
Pediatric Index of Emotional Distress. Minimum score is 0. Maximum score is 42. Lower score indicates lower levels of anxiety and depression.
Measured: Change from baseline to 12 months
Patient anxiety (child/teen self-report)
Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric anxiety questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of anxiety.
Measured: Change from baseline to 12 months
Patient depression (child/teen self-report)
Patient-reported Outcomes Measurement Information System (PROMIS) - pediatric depression questionnaire - short form (child/teen self-report). Minimum score is 8. Maximum score is 40. Lower score indicates lower level of depression.
Measured: Change from baseline to 12 months
Caregiver post-traumatic stress related to child's cancer diagnosis
Impact of Events scale - Revised (IES-R) (caregiver self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.
Measured: Change from baseline to 12 months
Patient post-traumatic stress related to own cancer diagnosis
Impact of Events scale - Revised (IES-R) (child/teen self-report). Mimimum score is 0. Maximum score is 88. Lower scores indicate lower levels of post-traumatic stress.
Measured: Change from baseline to 12 months
Caregiver coping with stress of child's cancer diagnosis
Responses to Stress Questionnaire - Cancer Version (caregiver self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.
Measured: Change from baseline to 12 months
Patient's own coping with stress of cancer diagnosis
Response to Stress Questionnaire - Cancer Version (patient self-report). Minimum score is 0. Maximum score is 1. A higher score indicates more engagement with active coping strategies.
Measured: Change from baseline to 12 months
Psychosocial risk
Psychosocial Assessment Tool (PAT) (caregiver report). Minimum score is 0. Maximum score is 3. Lower score indicates lower level of psychosocial risk.
Measured: Change from baseline to 12 months
Financial impact of pediatric cancer diagnosis and treatment on families.
Financial burden questionnaire (caregiver report). Minimum score is 22. Maximum score is 88. Higher score indicates lower level of financial impact on families.
Measured: Change from baseline to 12 months
Caregiver depression
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of depression.
Measured: Change from baseline to 12 months
Caregiver anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire (caregiver self-report). Minimum score is 6. Maximum score is 30. Lower scores indicate lower levels of anxiety.
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start27 Nov 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Maru Barrera, The Hospital for Sick Children
- Investigators
- Maru Barrera, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132856
- Sponsor's protocol ID
- 1000056445
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society; 2015.
Pinquart M, Shen Y. Behavior problems in children and adolescents with chronic physical illness: a meta-analysis. J Pediatr Psychol. 2011 Oct;36(9):1003-16. doi: 10.1093/jpepsy/jsr042. Epub 2011 Aug 1.
PubMed 21810623Kurtz BP, Abrams AN. Psychiatric aspects of pediatric cancer. Pediatr Clin North Am. 2011 Aug;58(4):1003-23, xii. doi: 10.1016/j.pcl.2011.06.009.
PubMed 21855719Kazak AE, Schneider S, Didonato S, Pai AL. Family psychosocial risk screening guided by the Pediatric Psychosocial Preventative Health Model (PPPHM) using the Psychosocial Assessment Tool (PAT). Acta Oncol. 2015 May;54(5):574-80. doi: 10.3109/0284186X.2014.995774. Epub 2015 Mar 9.
PubMed 25752970Pai AL, Patino-Fernandez AM, McSherry M, Beele D, Alderfer MA, Reilly AT, Hwang WT, Kazak AE. The Psychosocial Assessment Tool (PAT2.0): psychometric properties of a screener for psychosocial distress in families of children newly diagnosed with cancer. J Pediatr Psychol. 2008 Jan-Feb;33(1):50-62. doi: 10.1093/jpepsy/jsm053. Epub 2007 Jul 3.
PubMed 17609228Barrera M, Hancock K, Rokeach A, Cataudella D, Atenafu E, Johnston D, Punnett A, Nathan PC, Bartels U, Silva M, Cassidy M, Jansen P, Shama W, Greenberg C. External validity and reliability of the Psychosocial Assessment Tool (PAT) among Canadian parents of children newly diagnosed with cancer. Pediatr Blood Cancer. 2014 Jan;61(1):165-70. doi: 10.1002/pbc.24774. Epub 2013 Sep 17.
PubMed 24106172McCarthy MC, Clarke NE, Vance A, Ashley DM, Heath JA, Anderson VA. Measuring psychosocial risk in families caring for a child with cancer: the Psychosocial Assessment Tool (PAT2.0). Pediatr Blood Cancer. 2009 Jul;53(1):78-83. doi: 10.1002/pbc.22007.
PubMed 19343796Sint Nicolaas SM, Schepers SA, Hoogerbrugge PM, Caron HN, Kaspers GJ, van den Heuvel-Eibrink MM, Grootenhuis MA, Verhaak CM. Screening for Psychosocial Risk in Dutch Families of a Child With Cancer: Reliability, Validity, and Usability of the Psychosocial Assessment Tool. J Pediatr Psychol. 2016 Aug;41(7):810-9. doi: 10.1093/jpepsy/jsv119. Epub 2015 Dec 29.
PubMed 26715054Desjardins L, Hancock K, Szatmari P, Alexander S, Shama W, De Souza C, Mills D, Abla O, Barrera M. Protocol for mapping psychosocial screening to resources in pediatric oncology: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Jul 17;7(1):143. doi: 10.1186/s40814-021-00878-0.
PubMed 34274016
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Psychosocial Screening to Services for Children With Cancer: Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT04132856
- Acronym / sponsor ID
- 1000056445
- Conditions
- Cancer
- Keywords
- pediatric, oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 21 Oct 2019 (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.
Children with cancer are vulnerable to symptoms of anxiety and depression. Although screening for psychosocial distress is a standard of care for children with cancer, there is a limited knowledge
Detailed description
Background: Approximately 3 000 children and adolescents are diagnosed with cancer in Canada each year [Canadian Cancer Society]. Children with cancer experience higher rates of anxiety and depression symptoms relative to healthy controls [Pinquart \& Shen, 2011], and a subgroup are vulnerable to marked levels of psychological distress [Kurtz \& Abrams, 2011]. One standard for psychosocial care in pediatric cancer that is starting to be implemented across the United Stated and Canada is the systematic screening for psychosocial distress, using the Psychosocial Assessment Tool (PAT) [Kazak, Schneider, Didonato, Pai, 2015; Pai et al., 2008; Barrera et al., 2014; McCarthy et al., 2009; Sint Nicolaas et al., 2016]. However, a dearth of literature exists on how to bridge screening for psychosocial distress and the delivery of appropriate evidence-based mental health resources. The current study is a randomized controlled pilot intervention project which aims to test the feasibility and effects of introducing a psychosocial navigator who will coordinate the delivery of psychosocial resources to children with cancer and their families based on early screening and follow-up for psychosocial distress. Specific Objectives: 1) To determine the feasibility and utility of conducting psychosocial screening and providing an Enhanced Psychosocial Intervention (EPSI). 2) To examine the effects of EPSI, as compared to treatment as usual (TAU+), on the mental health, quality of life, coping, and social relationships of children with cancer. Methods: A randomized controlled feasibility intervention trial, with a TAU+ control group, will be conducted with newly diagnosed children with any type of cancer. Participants will be 10-18 years of age, medically suitable for participation, in active treatment, and the primary caregiver. Forty-eight child-caregiver dyads (24 in the intervention and 24 in the control group) will be enrolled. The EPSI will have two components: 1) Information about the psychosocial risk of the family and mental health of the child (e.g., depression) and 2) the Psychosocial Navigator (PSN) as resource for tailoring psychosocial resources to child-family distress, linking with the treating team. Measures of feasibility (recruitment, acceptability) will be documented throughout; initial screening using the PAT will be conducted 2-4 weeks post diagnosis (baseline); and using the distress thermometer, follow-up will be done at specific periods depending on the disease (leukemia/lymphoma, solid tumors, brain tumors). The primary psychosocial outcome (depression), and secondary outcomes (post-traumatic stress, pain, fatigue, coping, sleep quality, time and financial cost, social support and quality of life) will be completed at baseline and 12 months later. Descriptive statistics (frequency and percentage rates) will be provided for feasibility measures and PAT psychosocial risk categories. Means, standard deviations, and ranges will be provided for the primary and secondary outcomes. Preliminary analyses of group comparisons will also be performed via independent t tests and chi square tests. Further, analyses of covariance (ANCOVAs) will be conducted on the primary and secondary outcomes to test group differences at post-test while controlling for pretest scores.
Significance: The proposed intervention project will assess and address the psychosocial needs of newly diagnosed pediatric cancer patients and families. This intervention aims to improve the triaging of resources and enhance the effectiveness of psychosocial intervention for children with cancer. The enhanced intervention is expected to improve children's and adolescents' coping with disease-related stressors such as pain and uncertainty, improve their mood, and enhance social engagement with peers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Psychosocial Navigator, Other: Communication of Summary ProfileThe Intervention group will receive the services of the Psychosocial Navigator (PSN) monthly for the full 12 months of the study. At baseline, the PSN will provide the health care providers (HCPs) and family with recommendations for mapping and triaging of resources to levels of psychosocial risk (PAT: Universal, Targeted, Clinical) and level of depression and anxiety (mild, moderate, and high mental health problems; as determined by the standardized norms for the measures). This information will be summarized in the Communication Summary Profile and shared with the treating team (oncologist, nurse, and Social Worker, core psychosocial staff involved in the child's care) and family within 48 hours of completion. The PSN will conduct follow-up psychosocial screenings on a monthly basis, using the Distress Thermometer for children and caregivers. Results of the monthly assessments and recommended resources will also be communicated to the caregiver/parent and treating team of the youth. |
| Treatment as Usual Group | No intervention | –Current psychosocial care services will be accessible to Treatment as Usual Group (e.g., social work, child life, psychology, art and music therapy, and psychiatry). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between 10 and 18 years of age
- Clinical diagnosis of cancer
- Less than 4 weeks since diagnosis disclosure
- Primary caregiver must also consent to participation
Key exclusion criteria (2 listed)
- Cancer diagnosis disclosed more than 4 weeks ago.
- Primary caregiver declines to participate
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 |
|---|---|---|
| Psychosocial NavigatorServices of psychosocial navigator | Other | Intervention Group |
| Communication of Summary ProfileBoth patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety. | Other | Intervention Group |
Primary outcome
Feasibility pertaining to recruitment
Time frame: 12 months
Rate of recruitment as measured by percentage of participants who consent to participation as compared to those who are eligible and do not consent
Feasibility pertaining to retention
Time frame: 12 months
Rates of completed questionnaires at all time points
Satisfaction with Enhanced Intervention as assessed by questionnaire at completion of study
Time frame: 12 months
5 - point likert scale satisfaction questionnaire with 6 questions pertaining to usefulness and overall satisfaction with the enhanced intervention. The minimum score is 6 (low satisfaction) and the maximum score is 30 (high satisfaction).
Satisfaction with Enhanced Intervention as assessed by semi-structured interview at completion of study
Time frame: 12 months
Semi-structured interview with 6 questions including "What were your expectations about being in this study?"; "Were your expectations of the study met?"; "Do you have any additional comments/suggestions for the study?"
16 secondary outcomes
Distress
Time frame: Change from baseline to 12 months
Patient generic quality of life based on self report
Time frame: Change from baseline to 12 months
Patient generic quality of life based on caregiver report
Time frame: Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on self-report
Time frame: Change from baseline to 12 months
Patient quality of life as it relates to cancer, based on caregiver report
Time frame: Change from baseline to 12 months
Patient anxiety and depression - child/teem self report
Time frame: Change from baseline to 12 months
Patient anxiety (child/teen self-report)
Time frame: Change from baseline to 12 months
Patient depression (child/teen self-report)
Time frame: Change from baseline to 12 months
Caregiver post-traumatic stress related to child's cancer diagnosis
Time frame: Change from baseline to 12 months
Patient post-traumatic stress related to own cancer diagnosis
Time frame: Change from baseline to 12 months
Caregiver coping with stress of child's cancer diagnosis
Time frame: Change from baseline to 12 months
Patient's own coping with stress of cancer diagnosis
Time frame: Change from baseline to 12 months
Psychosocial risk
Time frame: Change from baseline to 12 months
Financial impact of pediatric cancer diagnosis and treatment on families.
Time frame: Change from baseline to 12 months
Caregiver depression
Time frame: Change from baseline to 12 months
Caregiver anxiety
Time frame: Change from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- BackgroundCanadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society; 2015.
- Background: PubMed 21810623Pinquart M, Shen Y. Behavior problems in children and adolescents with chronic physical illness: a meta-analysis. J Pediatr Psychol. 2011 Oct;36(9):1003-16. doi: 10.1093/jpepsy/jsr042. Epub 2011 Aug 1.
- Background: PubMed 21855719Kurtz BP, Abrams AN. Psychiatric aspects of pediatric cancer. Pediatr Clin North Am. 2011 Aug;58(4):1003-23, xii. doi: 10.1016/j.pcl.2011.06.009.
- Background: PubMed 25752970Kazak AE, Schneider S, Didonato S, Pai AL. Family psychosocial risk screening guided by the Pediatric Psychosocial Preventative Health Model (PPPHM) using the Psychosocial Assessment Tool (PAT). Acta Oncol. 2015 May;54(5):574-80. doi: 10.3109/0284186X.2014.995774. Epub 2015 Mar 9.
- Background: PubMed 17609228Pai AL, Patino-Fernandez AM, McSherry M, Beele D, Alderfer MA, Reilly AT, Hwang WT, Kazak AE. The Psychosocial Assessment Tool (PAT2.0): psychometric properties of a screener for psychosocial distress in families of children newly diagnosed with cancer. J Pediatr Psychol. 2008 Jan-Feb;33(1):50-62. doi: 10.1093/jpepsy/jsm053. Epub 2007 Jul 3.
- Background: PubMed 24106172Barrera M, Hancock K, Rokeach A, Cataudella D, Atenafu E, Johnston D, Punnett A, Nathan PC, Bartels U, Silva M, Cassidy M, Jansen P, Shama W, Greenberg C. External validity and reliability of the Psychosocial Assessment Tool (PAT) among Canadian parents of children newly diagnosed with cancer. Pediatr Blood Cancer. 2014 Jan;61(1):165-70. doi: 10.1002/pbc.24774. Epub 2013 Sep 17.
- Background: PubMed 19343796McCarthy MC, Clarke NE, Vance A, Ashley DM, Heath JA, Anderson VA. Measuring psychosocial risk in families caring for a child with cancer: the Psychosocial Assessment Tool (PAT2.0). Pediatr Blood Cancer. 2009 Jul;53(1):78-83. doi: 10.1002/pbc.22007.
- Background: PubMed 26715054Sint Nicolaas SM, Schepers SA, Hoogerbrugge PM, Caron HN, Kaspers GJ, van den Heuvel-Eibrink MM, Grootenhuis MA, Verhaak CM. Screening for Psychosocial Risk in Dutch Families of a Child With Cancer: Reliability, Validity, and Usability of the Psychosocial Assessment Tool. J Pediatr Psychol. 2016 Aug;41(7):810-9. doi: 10.1093/jpepsy/jsv119. Epub 2015 Dec 29.
- Derived from this study: PubMed 34274016Desjardins L, Hancock K, Szatmari P, Alexander S, Shama W, De Souza C, Mills D, Abla O, Barrera M. Protocol for mapping psychosocial screening to resources in pediatric oncology: a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Jul 17;7(1):143. doi: 10.1186/s40814-021-00878-0.
- 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.
Maru Barrera, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Navigator and Communication of Summary Profile in people with Cancer, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility pertaining to recruitment (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT04132856, which also lists 9 linked publications.
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 22 Oct 2020.