Colon Cancer, Rectal Cancer
Conditions
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.
Interventions
DEVICEMyChemoCare iPad application
Sponsors
McKesson Foundation
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MyChemoCare |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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.
Time frame: 8 weeks post-enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyChemoCare | Patient Retention and Engagement With the MyChemoCare Application | Completed the 8-week trial | 15 Participants |
| MyChemoCare | Patient Retention and Engagement With the MyChemoCare Application | Checked in at least 1 time per week | 12 Participants |
Primary
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.
Time frame: 8 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyChemoCare | Patient Satisfaction and Usability of the MyChemoCare Application | 3.95 units on a scale | Standard Error 0.16 |
Secondary
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.
Time frame: Baseline and 8 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChemoCare | Improved Quality of Life | 9 Participants |
Secondary
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.
Time frame: 8 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChemoCare | Increased Mastery of Cancer and Chemotherapy Symptoms | 9 Participants |
Secondary
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.
Time frame: 8 weeks post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChemoCare | Physician Use of the Study Feedback Mechanism | 16 Participants |
Secondary
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.
Time frame: 8 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChemoCare | Symptom Burden Reduction | 9 Participants |