Cancer4CPNCT02238951
Cancer Care Coordination for Chemotherapy Patients
A study testing Mobile Health (mHealth) and No mHealth in people with Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mobile Health (mHealth) and No mHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2017
- 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
- 18 years or older
- Newly diagnosed cancer - any site or stage
- Initiating chemotherapy
- Ability to read and write English
- Manual dexterity sufficient to use a tablet technology
- Cognitive capacity to participate
- Preferential recruitment of publicly insured and/or living in rural communities
Who cannot join
- Oral chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Comprehensive Cancer Care Center
Sacramento, California, 95817
About this study
Official title: Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.
The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.
Read the detailed description
This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.
All participants receive nurse-led care coordination throughout chemotherapy treatment.
RESEARCH AIMS:
- Demonstration of a HIPAA-compliant social networking platform;
- Facilitate communication and collaboration among patients with cancer and their care team;
- Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)
- Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;
- For patients assigned to the mobile health care coordination, understanding their experience of use of the technology
- Conditions
- Cancer
- Being tested
- Mobile Health (mHealth), No mHealth
- Keywords
- care coordination, mobile health, chemotherapy, technology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health (mHealth)Other
Also called Android-based device, Mobile health, Patient Health Network
Participants receive care coordination throughout their chemotherapy treatment using mHealth technology
No mHealthOther
Participants receive the same evidence-based care coordination without mHealth technology
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health (mHealth) | Experimental | Care coordination using mHealth technology enhancements Receives: Other: Mobile Health (mHealth) |
| No mHealth | Active comparator | Care coordination without mHealth enhancements Receives: Other: No mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Outcome
Pain
Measured: Baseline, 3 months, 6 months
Secondary outcomes (1)
Demonstration of a HIPAA-compliant platform to coordinate care overtime
- Technology Usability and Acceptance
- Patient engagement with technology
- Use of electronic medical record features to communicate with providers
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- McKesson Foundation, Boston University
- Responsible party
- Sponsor
- Investigators
- Jill G Joseph, MD, PhD, Principal investigator, University of California, Davis Betty Irene Moore School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238951
- Sponsor's protocol ID
- 551190
- Acronym
- 4CP
- Status last verified
- Nov 2018
- First submitted
- 10 Sep 2014
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.
- ClinicalTrials.gov ID
- NCT02238951
- Acronym / sponsor ID
- 4CP / 551190
- Conditions
- Cancer
- Keywords
- care coordination, mobile health, chemotherapy, technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- McKesson Foundation, Boston University
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 12 Sep 2014 (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.
The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.
Detailed description
This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.
All participants receive nurse-led care coordination throughout chemotherapy treatment.
RESEARCH AIMS:
- Demonstration of a HIPAA-compliant social networking platform;
- Facilitate communication and collaboration among patients with cancer and their care team;
- Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)
- Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;
- For patients assigned to the mobile health care coordination, understanding their experience of use of the technology
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health (mHealth) | Experimental | Other: Mobile Health (mHealth)Care coordination using mHealth technology enhancements |
| No mHealth | Active comparator | Other: No mHealthCare coordination without mHealth enhancements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Newly diagnosed cancer - any site or stage
- Initiating chemotherapy
- Ability to read and write English
- Manual dexterity sufficient to use a tablet technology
Key exclusion criteria (1 listed)
- Oral chemotherapy
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 |
|---|---|---|
| Mobile Health (mHealth)Also: Android-based device, Mobile health, Patient Health NetworkParticipants receive care coordination throughout their chemotherapy treatment using mHealth technology | Other | Mobile Health (mHealth) |
| No mHealthParticipants receive the same evidence-based care coordination without mHealth technology | Other | No mHealth |
Primary outcome
Change in Patient Health Outcome
Time frame: Baseline, 3 months, 6 months
Pain
1 secondary outcome
Demonstration of a HIPAA-compliant platform to coordinate care overtime
Time frame: Baseline, 6 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 16 Nov 2018.
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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.
Jill G Joseph, MD, PhD principal investigator
University of California, Davis Betty Irene Moore School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health (mHealth) and No mHealth in people with Cancer, run by University of California, Davis 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 7 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 16 Nov 2018. 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 Patient Health Outcome (time frame: Baseline, 3 months, 6 months). 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 16 Nov 2018.