Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: MyChemoCare iPad application
|
Outcome Measures
Primary Outcome Measures
- Patient Retention and Engagement With the MyChemoCare Application [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 [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.
Secondary Outcome Measures
- Physician Use of the Study Feedback Mechanism [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.
- Increased Mastery of Cancer and Chemotherapy Symptoms [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.
- Symptom Burden Reduction [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.
- Improved Quality of Life [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- McKesson Foundation
Investigators
- Principal Investigator: Larry C An, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-PAF07680
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 Participants | 16 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
55.9
(9.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
8
50%
|
| Male |
8
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
16
100%
|
Outcome Measures
| Title | Patient Retention and Engagement With the MyChemoCare Application |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 16 |
| Completed the 8-week trial |
15
93.8%
|
| Checked in at least 1 time per week |
12
75%
|
| Title | Patient Satisfaction and Usability of the MyChemoCare Application |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 15 |
| Mean (Standard Error) [units on a scale] |
3.95
(0.16)
|
| Title | Physician Use of the Study Feedback Mechanism |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 16 |
| Count of Participants [Participants] |
16
100%
|
| Title | Increased Mastery of Cancer and Chemotherapy Symptoms |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 15 |
| Count of Participants [Participants] |
9
56.3%
|
| Title | Symptom Burden Reduction |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 15 |
| Count of Participants [Participants] |
9
56.3%
|
| Title | Improved Quality of Life |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MyChemoCare |
|---|---|
| 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 |
| Measure Participants | 15 |
| Count of Participants [Participants] |
9
56.3%
|
Adverse Events
| Time Frame | 8 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | MyChemoCare | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| MyChemoCare | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| MyChemoCare | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | |
Limitations/Caveats
More Information
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 |
| lcan@med.umich.edu |
- 12-PAF07680