Pediatric CancerNCT02998086
PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
A study testing Promoting Resilience in Stress Management in people with Pediatric Cancer, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Promoting Resilience in Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2016to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are aged 2-24 years
- Have been diagnosed with new malignancy between 1-10 weeks prior
- Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
- Has provided written informed consent (child aged 18 years and older), written assent (child aged 13-17 years), verbal assent (child aged 7-12 years).
- Able to speak and read English language
- Cognitively able to participate in interactive interviews
Who cannot join
- Parent is < 18 years of age
- Parent is cognitively or physically unable to participate in interactive interview
- Parent is unable to speak and read English language
- Parent or child participated on prior PRISM intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98145
About this study
Official title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care.
Read the detailed description
Parenting a child with cancer is highly distressing. Both during and after cancer therapy, parents may suffer from poor mental health, risky health behaviors, and financial hardship, all of which may impact patients, siblings, and the family unit. Positive psychological resources can mitigate negative outcomes. In this regard, resilience is particularly important, describing an individual's ability to maintain psychological and/or physical well-being in the face of stress.
The investigators have previously described the "Promoting Resilience in Stress Management" (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1 intervention targets four "resilience resources" over approximately 3 months: skills in stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making. Notably, every parent whose child received the PRISM requested a similar intervention for him- or herself. Hence, the investigators adapted two versions of the intervention for parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst 12 parents of children with cancer. Feedback was highly positive; however, many parents requested additional group-based social support. Second, they conducted a half-day symposium and administered small-group adaptations of the PRISM-P to 70 parents of children with serious illness. Feedback was again positive; however, the opportunity to develop individual skills was limited.
This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies and preferences for future, larger studies. Consecutive eligible parents of children with newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25 per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals, optimism, benefit-finding, psychological distress, and health behaviors, and ongoing perceptions of usefulness, feasibility, and preference.
- Conditions
- Pediatric Cancer
- Being tested
- Promoting Resilience in Stress Management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience in Stress ManagementBehavioural
Also called PRISM
Skills-based intervention designed to promote resilience resources
| Study group | Role | What they receive |
|---|---|---|
| Individual (1:1) | Experimental | Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention Receives: Behavioral: Promoting Resilience in Stress Management |
| Group | Experimental | Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention Receives: Behavioral: Promoting Resilience in Stress Management |
| Usual Care | No intervention | Usual non-directed psychosocial supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-Reported Resilience
Measured: 3 months
Secondary outcomes (5)
Parent-reported Stress Survey Response
Measured: 3 months
Parent-reported psychological distress Survey Response
Measured: 3 months
Parent-reported social support Survey Response
Measured: 3 months
Parent-reported quality of life Survey Response
Measured: 3 months
Parent-reported benefit finding Survey Response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start5 Dec 2016
- Primary completion30 Dec 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby Rosenberg, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998086
- Sponsor's protocol ID
- SC-N120
- Status last verified
- Mar 2021
- First submitted
- 13 Dec 2016
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rosenberg AR, Zhou C, Bradford MC, Barton K, Junkins CC, Taylor M, Kross EK, Curtis JR, Dionne-Odom JN, Yi-Frazier JP. Parent Perspectives after the PRISM-P Randomized Trial: A Mixed-Methods Analysis. J Palliat Med. 2021 Sep;24(10):1505-1515. doi: 10.1089/jpm.2020.0720. Epub 2021 Mar 15.
PubMed 33720787Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.
PubMed 31532518
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT02998086
- Acronym / sponsor ID
- SC-N120
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care.
Detailed description
Parenting a child with cancer is highly distressing. Both during and after cancer therapy, parents may suffer from poor mental health, risky health behaviors, and financial hardship, all of which may impact patients, siblings, and the family unit. Positive psychological resources can mitigate negative outcomes. In this regard, resilience is particularly important, describing an individual's ability to maintain psychological and/or physical well-being in the face of stress.
The investigators have previously described the "Promoting Resilience in Stress Management" (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1 intervention targets four "resilience resources" over approximately 3 months: skills in stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making. Notably, every parent whose child received the PRISM requested a similar intervention for him- or herself. Hence, the investigators adapted two versions of the intervention for parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst 12 parents of children with cancer. Feedback was highly positive; however, many parents requested additional group-based social support. Second, they conducted a half-day symposium and administered small-group adaptations of the PRISM-P to 70 parents of children with serious illness. Feedback was again positive; however, the opportunity to develop individual skills was limited.
This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies and preferences for future, larger studies. Consecutive eligible parents of children with newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25 per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals, optimism, benefit-finding, psychological distress, and health behaviors, and ongoing perceptions of usefulness, feasibility, and preference.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual (1:1) | Experimental | Behavioral: Promoting Resilience in Stress ManagementIndividual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention |
| Group | Experimental | Behavioral: Promoting Resilience in Stress ManagementGroup-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention |
| Usual Care | No intervention | –Usual non-directed psychosocial supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are aged 2-24 years
- Have been diagnosed with new malignancy between 1-10 weeks prior
- Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
- Has provided written informed consent (child aged 18 years and older), written assent (child aged 13-17 years), verbal assent (child aged 7-12 years).
- Able to speak and read English language
Key exclusion criteria (4 listed)
- Parent is < 18 years of age
- Parent is cognitively or physically unable to participate in interactive interview
- Parent is unable to speak and read English language
- Parent or child participated on prior PRISM intervention study
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 |
|---|---|---|
| Promoting Resilience in Stress ManagementAlso: PRISMSkills-based intervention designed to promote resilience resources | Behavioural | Group, Individual (1:1) |
Primary outcome
Parent-Reported Resilience
Time frame: 3 months
5 secondary outcomes
Parent-reported Stress Survey Response
Time frame: 3 months
Parent-reported psychological distress Survey Response
Time frame: 3 months
Parent-reported social support Survey Response
Time frame: 3 months
Parent-reported quality of life Survey Response
Time frame: 3 months
Parent-reported benefit finding Survey Response
Time frame: 3 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 17 Mar 2021.
- Derived from this study: PubMed 33720787Rosenberg AR, Zhou C, Bradford MC, Barton K, Junkins CC, Taylor M, Kross EK, Curtis JR, Dionne-Odom JN, Yi-Frazier JP. Parent Perspectives after the PRISM-P Randomized Trial: A Mixed-Methods Analysis. J Palliat Med. 2021 Sep;24(10):1505-1515. doi: 10.1089/jpm.2020.0720. Epub 2021 Mar 15.
- Derived from this study: PubMed 31532518Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Resilience in Stress Management in people with Pediatric Cancer, run by Seattle Children's Hospital at 1 site in United States.
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 6 inclusion and 4 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 17 Mar 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 United States. 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?
Parent-Reported Resilience (time frame: 3 months). 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 NCT02998086, which also lists 2 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 17 Mar 2021.