Pediatric CancerNCT05112458
Cope 360 App for Caregivers of Children With Cancer
A study testing Cope 360 mobile health application in people with Pediatric Cancer, run by Indiana University.
Trial summary
To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Cope 360 mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English-speaking (app is in English)
- Caregiver (parent, legal guardian, grandparent, etc.) to a child with cancer
- Caregiver to a child with cancer currently undergoing therapy (chemotherapy, radiation, etc.)
- Caregiver to a child with cancer who anticipates therapy to continue for 6 months after recruitment
- Caregiver to a child with cancer between the ages of 0 and 21 years old
- Must own a smartphone or other internet capable mobile device
Who cannot join
- Non-English speaking (app is in English)
- Caregiver with a child with cancer who is not currently undergoing therapy
- Caregiver to a child with cancer who does not anticipate therapy to continue for 6 months after recruitment
- Caregiver with a child over age 21
- Caregiver who do not own a smartphone or other internet capable mobile device
About this study
Official title: Pilot Randomized Control Trial of Cope 360 App for Caregivers of Children With Cancer
To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved ability to cope, increased self-efficacy, and improved aspects of caregivers' quality of life. Yet, several recent reviews highlighted a lack of interventions to provide practical skills for the day-to-day provision of care. The investigators have developed a pediatric oncology caregiver-focused intervention that seeks to improve caregiver clinical skills/knowledge, self-efficacy, and support seeking skills.
Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. The investigators propose to evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Read the detailed description
Procedure: The investigators will identify approximately 164 primary caregivers of children with cancer, 82 for both the intervention group and the usual care group. Those in the intervention group will be presented with the mHealth app and with the help of the RA, the participants will download the app onto their personal smartphone. Participants will be asked to use the app for a 6-month period of time. They will also receive standardized education that is provided to all caregivers of newly diagnosed patients at the investigator's institution. Those in the usual care group will receive standardized education. These caregivers will NOT be provided with access to the app.
After a participant has been enrolled in the study, the RA will collect demographic and contact information and will administer baseline assessments. Follow-up surveys with a unique identifier will be administered via email at 1, 3 and 6 months for caregivers in both the intervention and control groups. If a survey is not completed, the RA will attempt to contact the participant by phone. Surveys will be administered via Qualtrics. The investigators will collect data via these surveys on participant demographics and mobile technology usage, and outcomes will be measured utilizing the following assessments: the Caregiver Self-Efficacy scale, Caregiver Mastery scale, Pediatric Inventory for Parents, and the Technology Acceptance Model. Semi-structured interviews will be done with a subset of participants in the intervention group at the 6-month mark. Intervention participants will be contacted by phone or email and asked to participate in the interview until a subset of 30 is reached. Interviews will be conducted in person, by phone, or by Zoom videoconferencing depending on the clinic schedule of the participant's child.
Randomization: Caregivers will be randomized into either the intervention group or the usual care group. Randomization tables will be generated with SAS v9.4 utilizing the PROC PLAN procedure.
Data Collection and Analysis: Data will be collected on a variety of socio-demographic factors that have been hypothesized to impact acceptability and use of technology: age, education, gender, race, income, prior experience/exposure/awareness with computer or health technology. Information gathered will also include basic information about their child's cancer diagnosis including: type of cancer, date of diagnosis, and type of treatment protocol. Semi-structured interviews will transcribed and analyzed using Nvivo qualitative research software. Survey data will be analyzed with SAS v9.4, Qualtrics, and Microsoft Excel.
- Conditions
- Pediatric Cancer
- Being tested
- Cope 360 mobile health application, Usual care
- Keywords
- mobile health, supportive care, adolescent, child, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cope 360 mobile health applicationOther
Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. We will evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Usual careOther
Caregivers of children with cancer will receive the usual clinical care provided to our patient population.
| Study group | Role | What they receive |
|---|---|---|
| Cope 360 application | Experimental | Participants are given access to the application and will use it to care for their child with cancer for a period of 6 months. Receives: Other: Cope 360 mobile health application |
| Usual Care | Active comparator | Participants are given usual care and not given access to the application. They will be surveyed along with the experimental group for a period of 6 months. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technology Feasibility Scale Rating
Feasibility of participant use over an extended period of time; measured using the Technology Acceptance Model (TAM).
Measured: 6 months
Qualitative Technology Feasibility
Feasibility of participant use over an extended period of time; measured using semi-structured qualitative interviews.
Measured: 6 months
Data Log User Acceptability
Acceptability by caregivers in a real-world setting; measured using audits of usage data and recorded or reported errors from data logs.
Measured: 6 months
Self-Efficacy Scale Rating
Caregiver self-efficacy, measured using the Caregiver Self-Efficacy scale.
Measured: 6 months
Mastery of Caregiving Scale Rating
Mastery of caregiving skills/knowledge; measured using the the Caregiver Mastery scale.
Measured: 6 months
Stress Reduction Scale Rating
Reduction in caregiver stress; measured using the Pediatric Inventory for Parents assessment scale.
Measured: 6 months
Healthcare Utilization Effect
Effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study startJul 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Grant funding ended prior to enrolling any participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Model description
- Half of the participants will receive the intervention and half will receive standard care. All will be assessed at enrollment, 1 month, 3 month, and 6 month time points.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Emily L Mueller, Indiana University
- Investigators
- Emily L Mueller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112458
- Sponsor's protocol ID
- 11097
- Other IDs
- 5K08CA230218-04
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2021
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Control Trial of Cope 360 App for Caregivers of Children With Cancer
- ClinicalTrials.gov ID
- NCT05112458
- Acronym / sponsor ID
- 11097
- Conditions
- Pediatric Cancer
- Keywords
- mobile health, supportive care, adolescent, child, oncology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant funding ended prior to enrolling any participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Nov 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.
To date, most caregiver focused interventions have been targeted at caregivers of adults with cancer, completely ignoring the unique needs of caregivers of children with cancer. A recent meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced burden, improved ability to cope, increased self-efficacy, and improved aspects of caregivers' quality of life. Yet, several recent reviews highlighted a lack of interventions to provide practical skills for the day-to-day provision of care. The investigators have developed a pediatric oncology caregiver-focused intervention that seeks to improve caregiver clinical skills/knowledge, self-efficacy, and support seeking skills.
Cope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. The investigators propose to evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Detailed description
Procedure: The investigators will identify approximately 164 primary caregivers of children with cancer, 82 for both the intervention group and the usual care group. Those in the intervention group will be presented with the mHealth app and with the help of the RA, the participants will download the app onto their personal smartphone. Participants will be asked to use the app for a 6-month period of time. They will also receive standardized education that is provided to all caregivers of newly diagnosed patients at the investigator's institution. Those in the usual care group will receive standardized education. These caregivers will NOT be provided with access to the app.
After a participant has been enrolled in the study, the RA will collect demographic and contact information and will administer baseline assessments. Follow-up surveys with a unique identifier will be administered via email at 1, 3 and 6 months for caregivers in both the intervention and control groups. If a survey is not completed, the RA will attempt to contact the participant by phone. Surveys will be administered via Qualtrics. The investigators will collect data via these surveys on participant demographics and mobile technology usage, and outcomes will be measured utilizing the following assessments: the Caregiver Self-Efficacy scale, Caregiver Mastery scale, Pediatric Inventory for Parents, and the Technology Acceptance Model. Semi-structured interviews will be done with a subset of participants in the intervention group at the 6-month mark. Intervention participants will be contacted by phone or email and asked to participate in the interview until a subset of 30 is reached. Interviews will be conducted in person, by phone, or by Zoom videoconferencing depending on the clinic schedule of the participant's child.
Randomization: Caregivers will be randomized into either the intervention group or the usual care group. Randomization tables will be generated with SAS v9.4 utilizing the PROC PLAN procedure.
Data Collection and Analysis: Data will be collected on a variety of socio-demographic factors that have been hypothesized to impact acceptability and use of technology: age, education, gender, race, income, prior experience/exposure/awareness with computer or health technology. Information gathered will also include basic information about their child's cancer diagnosis including: type of cancer, date of diagnosis, and type of treatment protocol. Semi-structured interviews will transcribed and analyzed using Nvivo qualitative research software. Survey data will be analyzed with SAS v9.4, Qualtrics, and Microsoft Excel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the participants will receive the intervention and half will receive standard care. All will be assessed at enrollment, 1 month, 3 month, and 6 month time points.
| Arm | Type | Receives |
|---|---|---|
| Cope 360 application | Experimental | Other: Cope 360 mobile health applicationParticipants are given access to the application and will use it to care for their child with cancer for a period of 6 months. |
| Usual Care | Active comparator | Other: Usual careParticipants are given usual care and not given access to the application. They will be surveyed along with the experimental group for a period of 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking (app is in English)
- Caregiver (parent, legal guardian, grandparent, etc.) to a child with cancer
- Caregiver to a child with cancer currently undergoing therapy (chemotherapy, radiation, etc.)
- Caregiver to a child with cancer who anticipates therapy to continue for 6 months after recruitment
- Caregiver to a child with cancer between the ages of 0 and 21 years old
Key exclusion criteria (5 listed)
- Non-English speaking (app is in English)
- Caregiver with a child with cancer who is not currently undergoing therapy
- Caregiver to a child with cancer who does not anticipate therapy to continue for 6 months after recruitment
- Caregiver with a child over age 21
- Caregiver who do not own a smartphone or other internet capable mobile device
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 |
|---|---|---|
| Cope 360 mobile health applicationCope 360 is a mHealth (mobile health) app designed to support caregivers of children with cancer with symptom tracking, medication management, and emergency preparedness. We will evaluate Cope 360 via a pilot, randomized control trial in which some caregivers will receive the app and some will not. The purpose of this study is to assess: 1) feasibility of caregiver use over extended period of time, 2) acceptability of the mHealth tool by caregivers in a real-world setting, 3) impact of the mHealth tool on caregiver self-efficacy, mastery of caregiving skills/knowledge, and caregiver stress, and 4) effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters). | Other | Cope 360 application |
| Usual careCaregivers of children with cancer will receive the usual clinical care provided to our patient population. | Other | Usual Care |
Primary outcome
Technology Feasibility Scale Rating
Time frame: 6 months
Feasibility of participant use over an extended period of time; measured using the Technology Acceptance Model (TAM).
Qualitative Technology Feasibility
Time frame: 6 months
Feasibility of participant use over an extended period of time; measured using semi-structured qualitative interviews.
Data Log User Acceptability
Time frame: 6 months
Acceptability by caregivers in a real-world setting; measured using audits of usage data and recorded or reported errors from data logs.
Self-Efficacy Scale Rating
Time frame: 6 months
Caregiver self-efficacy, measured using the Caregiver Self-Efficacy scale.
Mastery of Caregiving Scale Rating
Time frame: 6 months
Mastery of caregiving skills/knowledge; measured using the the Caregiver Mastery scale.
Stress Reduction Scale Rating
Time frame: 6 months
Reduction in caregiver stress; measured using the Pediatric Inventory for Parents assessment scale.
Healthcare Utilization Effect
Time frame: 6 months
Effect on healthcare utilization of the child with cancer (i.e. preliminary data about sick visits and ED encounters).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
Emily L Mueller, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Cope 360 mobile health application in people with Pediatric Cancer, run by Indiana University.
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 5 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: withdrawn, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Technology Feasibility Scale Rating (time frame: 6 months). The study lists 7 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 15 Aug 2024.