Trial Outcomes & Findings for Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management (NCT NCT02460822)

NCT ID: NCT02460822

Last Updated: 2017-05-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

8 weeks post-enrollment

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure
MyChemoCare
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 Study
STARTED
16
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
MyChemoCare
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 Study
Withdrawal by Subject
1

Baseline Characteristics

Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MyChemoCare
n=16 Participants
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
Age, Continuous
55.9 years
STANDARD_DEVIATION 9.6 • n=99 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
Region of Enrollment
United States
16 participants
n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=16 Participants
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
Patient Retention and Engagement With the MyChemoCare Application
Completed the 8-week trial
15 Participants
Patient Retention and Engagement With the MyChemoCare Application
Checked in at least 1 time per week
12 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=15 Participants
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
Patient Satisfaction and Usability of the MyChemoCare Application
3.95 units on a scale
Standard Error 0.16

SECONDARY outcome

Timeframe: 8 weeks post-enrollment

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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=16 Participants
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
Physician Use of the Study Feedback Mechanism
16 Participants

SECONDARY outcome

Timeframe: 8 weeks post enrollment

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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=15 Participants
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
Increased Mastery of Cancer and Chemotherapy Symptoms
9 Participants

SECONDARY outcome

Timeframe: 8 weeks post enrollment

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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=15 Participants
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
Symptom Burden Reduction
9 Participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks post enrollment

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.

Outcome measures

Outcome measures
Measure
MyChemoCare
n=15 Participants
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
Improved Quality of Life
9 Participants

Adverse Events

MyChemoCare

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lawrence C. An

University of Michigan

Phone: 734-763-6099

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place