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Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02460822
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
McKesson Foundation
Information provided by (Responsible Party):
Lawrence C. An, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Colon Cancer
Rectal Cancer
Intervention Device: MyChemoCare iPad application
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MyChemoCare
Hide Arm/Group Description

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.

MyChemoCare iPad application

Period Title: Overall Study
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title MyChemoCare
Hide Arm/Group Description

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.

MyChemoCare iPad application

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
55.9  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Patient Retention and Engagement With the MyChemoCare Application
Hide Description 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.
Time Frame 8 weeks post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Completed the 8-week trial
15
  93.8%
Checked in at least 1 time per week
12
  75.0%
2.Primary Outcome
Title Patient Satisfaction and Usability of the MyChemoCare Application
Hide Description

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.

Time Frame 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: units on a scale
3.95  (0.16)
3.Secondary Outcome
Title Physician Use of the Study Feedback Mechanism
Hide Description 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.
Time Frame 8 weeks post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
16
 100.0%
4.Secondary Outcome
Title Increased Mastery of Cancer and Chemotherapy Symptoms
Hide Description

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.

Time Frame 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
5.Secondary Outcome
Title Symptom Burden Reduction
Hide Description

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.

Time Frame 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
6.Secondary Outcome
Title Improved Quality of Life
Hide Description

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.

Time Frame Baseline and 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MyChemoCare
Hide Arm/Group Description:

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.

MyChemoCare iPad application

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MyChemoCare
Hide Arm/Group Description

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.

MyChemoCare iPad application

All-Cause Mortality
MyChemoCare
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MyChemoCare
Affected / at Risk (%)
Total   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MyChemoCare
Affected / at Risk (%)
Total   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lawrence C. An
Organization: University of Michigan
Phone: 734-763-6099
Responsible Party: Lawrence C. An, University of Michigan
ClinicalTrials.gov Identifier: NCT02460822     History of Changes
Other Study ID Numbers: 12-PAF07680
First Submitted: October 22, 2014
First Posted: June 2, 2015
Results First Submitted: March 29, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017