Colon CancerNCT02460822
Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
A study testing MyChemoCare iPad application in people with Colon Cancer and Rectal Cancer, run by University of Michigan at 1 site in United States.
Trial summary
This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- MyChemoCare iPad application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with colon or rectal cancer
- Expected to live at least 6 months
- Initiating chemotherapy for the first time in their treatment history
- Physically and mentally able to participate
- Able to read English
- Willing and able to sign informed consent
Who cannot join
- A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
- A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
- A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
- Received prior cytotoxic chemotherapy for any reason
- A diagnosed psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- MyChemoCare iPad application
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChemoCare iPad applicationDevice
| Study group | Role | What they receive |
|---|---|---|
| MyChemoCare | Experimental | Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen. Receives: Device: MyChemoCare iPad application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Retention and Engagement With the MyChemoCare Application
Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.
Measured: 8 weeks post-enrollment
Patient Satisfaction and Usability of the MyChemoCare Application
The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.
This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree.
Measured: 8 weeks post enrollment
Secondary outcomes (4)
Physician Use of the Study Feedback Mechanism
The investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.
Measured: 8 weeks post-enrollment
Increased Mastery of Cancer and Chemotherapy Symptoms
The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed.
The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified.
Measured: 8 weeks post enrollment
Symptom Burden Reduction
The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items.
The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified.
Measured: 8 weeks post enrollment
Improved Quality of Life
The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well).
The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified.
Measured: Baseline and 8 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- McKesson Foundation
- Responsible party
- Principal investigator, Lawrence C. An, University of Michigan
- Investigators
- Larry C An, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460822
- Sponsor's protocol ID
- 12-PAF07680
- Status last verified
- Mar 2017
- First submitted
- 22 Oct 2014
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
- ClinicalTrials.gov ID
- NCT02460822
- Acronym / sponsor ID
- 12-PAF07680
- Conditions
- Colon Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- McKesson Foundation
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyChemoCare | Experimental | Device: MyChemoCare iPad applicationParticipants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with colon or rectal cancer
- Expected to live at least 6 months
- Initiating chemotherapy for the first time in their treatment history
- Physically and mentally able to participate
- Able to read English
Key exclusion criteria (5 listed)
- A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
- A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
- A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
- Received prior cytotoxic chemotherapy for any reason
- A diagnosed psychiatric disorder
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 |
|---|---|---|
| MyChemoCare iPad application | Device | MyChemoCare |
Primary outcome
Patient Retention and Engagement With the MyChemoCare Application
Time frame: 8 weeks post-enrollment
Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.
Patient Satisfaction and Usability of the MyChemoCare Application
Time frame: 8 weeks post enrollment
The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app. This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree.
4 secondary outcomes
Physician Use of the Study Feedback Mechanism
Time frame: 8 weeks post-enrollment
Increased Mastery of Cancer and Chemotherapy Symptoms
Time frame: 8 weeks post enrollment
Symptom Burden Reduction
Time frame: 8 weeks post enrollment
Improved Quality of Life
Time frame: Baseline and 8 weeks post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Larry C An, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChemoCare iPad application in people with Colon Cancer and Rectal Cancer, run by University of Michigan 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 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: finished, as of the sponsor's last update on 11 May 2017. 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?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Retention and Engagement With the MyChemoCare Application (time frame: 8 weeks post-enrollment). The study lists 2 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 11 May 2017.