Childhood CancerGoalKeeperNCT03620071
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity
A study testing GoalKeeper in people with Childhood Cancer and Cerebral Palsy, run by Stanford University at 1 site in United States.
Trial summary
This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer, Cerebral Palsy, Chronic Lung Disease
- What is being tested?
- GoalKeeper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 17 Mar 2021
- 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
- Parent-child dyads and their medical provider
- Parent and provider age 18 years or older
- Parent English- or Spanish-speaking
- Child > age 12 months and <12 years old
Who cannot join
- Parent with known mental illness or neurocognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Children's Health
Palo Alto, California, 94304
About this study
Official title: Intelligent Information Sharing: Advancing Teamwork in Complex Care
This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.
Read the detailed description
The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention.
Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment.
The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice.
Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.
- Conditions
- Childhood Cancer, Cerebral Palsy, Chronic Lung Disease, Congenital Heart Disease, Congenital Metabolic Disorder, Gastrostomy
- Being tested
- GoalKeeper, Standard Care
- Keywords
- complex chronic condition, care coordination, shared decision making, health literacy
- Medical subject headings
- Neoplasms, Cerebral Palsy, Heart Defects, Congenital, Metabolism, Inborn Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoalKeeperOther
Mobile-health communication tool for parents of children with medical complexity
Standard CareOther
Standard Clinical Care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care Receives: Other: GoalKeeper; Other: Standard Care |
| Control | Experimental | Standard Care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up
Parent perception of goal-centered care will be measured using a modified version of the "Patient Assessment of Chronic Illness Care, Goal-Setting Domain" questionnaire, using a scale of 1(Almost Never) to 5 (Almost Always) with higher values representing better goal-centered care.
Measured: Baseline and 1-Month Follow-up
Secondary outcomes (1)
Count of parent participants with change in perception of goal-centered care from baseline to 3-Month Follow-up based on Investigator assessment.
Change in perception in quality of goal-centered care will be assessed by Investigators based on parent baseline interviews and parent exit interviews.
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start19 Apr 2019
- Primary completion19 Jan 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Harvard University
- Responsible party
- Sponsor
- Investigators
- Lee M Sanders, MD, MPH, Principal investigator, Associate Professor, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620071
- Sponsor's protocol ID
- 1R01CA204585-01
- Other IDs
- 1R01CA204585-01
- Acronym
- GoalKeeper
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2018
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin JL, Clark CL, Halpern-Felsher B, Bennett PN, Assis-Hassid S, Amir O, Nunez YC, Cleary NM, Gehrmann S, Grosz BJ, Sanders LM. Parent Perspectives in Shared Decision-Making for Children With Medical Complexity. Acad Pediatr. 2020 Nov-Dec;20(8):1101-1108. doi: 10.1016/j.acap.2020.06.008. Epub 2020 Jun 12.
PubMed 32540424Lin J, Huber B, Amir O, Assis-Hassid S, Gehrmann S, Gajos K, Grosz B, Sanders L. Novel Web-Based Technology to Promote Goal-Setting in Complex Chronic Illness: Randomized Controlled Trial. JMIR Hum Factors. 2026 Feb 20;13:e70402. doi: 10.2196/70402.
PubMed 41719520Lin JL, Huber B, Amir O, Gehrmann S, Ramirez KS, Ochoa KM, Asch SM, Gajos KZ, Grosz BJ, Sanders LM. Barriers and Facilitators to the Implementation of Family-Centered Technology in Complex Care: Feasibility Study. J Med Internet Res. 2022 Aug 23;24(8):e30902. doi: 10.2196/30902.
PubMed 35998021
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Information Sharing: Advancing Teamwork in Complex Care
- ClinicalTrials.gov ID
- NCT03620071
- Acronym / sponsor ID
- GoalKeeper / 1R01CA204585-01
- Conditions
- Childhood Cancer, Cerebral Palsy, Chronic Lung Disease, Congenital Heart Disease, Congenital Metabolic Disorder, Gastrostomy
- Keywords
- complex chronic condition, care coordination, shared decision making, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Harvard University
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 8 Aug 2018 (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.
This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.
Detailed description
The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention.
Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment.
The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice.
Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: GoalKeeper, Other: Standard CareReceipt of a novel mobile-health tool, GoalKeeper Plus Standard Care |
| Control | Experimental | Other: Standard CareStandard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parent-child dyads and their medical provider
- Parent and provider age 18 years or older
- Parent English- or Spanish-speaking
- Child > age 12 months and <12 years old
Key exclusion criteria (1 listed)
- Parent with known mental illness or neurocognitive impairment.
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 |
|---|---|---|
| GoalKeeperMobile-health communication tool for parents of children with medical complexity | Other | Intervention |
| Standard CareStandard Clinical Care | Other | Control, Intervention |
Primary outcome
Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up
Time frame: Baseline and 1-Month Follow-up
Parent perception of goal-centered care will be measured using a modified version of the "Patient Assessment of Chronic Illness Care, Goal-Setting Domain" questionnaire, using a scale of 1(Almost Never) to 5 (Almost Always) with higher values representing better goal-centered care.
1 secondary outcome
Count of parent participants with change in perception of goal-centered care from baseline to 3-Month Follow-up based on Investigator assessment.
Time frame: Baseline and 3 month follow-up
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 26 Sep 2023.
- Results publication: PubMed 32540424Lin JL, Clark CL, Halpern-Felsher B, Bennett PN, Assis-Hassid S, Amir O, Nunez YC, Cleary NM, Gehrmann S, Grosz BJ, Sanders LM. Parent Perspectives in Shared Decision-Making for Children With Medical Complexity. Acad Pediatr. 2020 Nov-Dec;20(8):1101-1108. doi: 10.1016/j.acap.2020.06.008. Epub 2020 Jun 12.
- Derived from this study: PubMed 41719520Lin J, Huber B, Amir O, Assis-Hassid S, Gehrmann S, Gajos K, Grosz B, Sanders L. Novel Web-Based Technology to Promote Goal-Setting in Complex Chronic Illness: Randomized Controlled Trial. JMIR Hum Factors. 2026 Feb 20;13:e70402. doi: 10.2196/70402.
- Derived from this study: PubMed 35998021Lin JL, Huber B, Amir O, Gehrmann S, Ramirez KS, Ochoa KM, Asch SM, Gajos KZ, Grosz BJ, Sanders LM. Barriers and Facilitators to the Implementation of Family-Centered Technology in Complex Care: Feasibility Study. J Med Internet Res. 2022 Aug 23;24(8):e30902. doi: 10.2196/30902.
- 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.
Lee M Sanders, MD, MPH principal investigator
Associate Professor, Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoalKeeper in people with Childhood Cancer and Cerebral Palsy, run by Stanford University 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 4 inclusion and 1 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 26 Sep 2023. 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?
Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up (time frame: Baseline and 1-Month Follow-up). 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 NCT03620071, which also lists 3 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 26 Sep 2023.