CancerLife: Patient-Driven Solution in Cancer Care

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the use of a digital information and communication platform (DICP) in improving outcomes in patients with cancer and their caregivers.

Detailed Description
-----------------
This is a nonblinded, randomized, controlled trial of a digital information and communication platform (DICP) in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care Patients initiating and/or receiving systemic treatment for cancer will be enrolled in a nonblinded, randomized, controlled trial of a DICP in self-reporting and monitoring of cancer and cancer-treatment related symptoms compared with usual care. The study will require one (1) study encounter for consenting purposes. All participants entering their information on the registration page will be contacted by a study team member for informed consent. Eligible subjects who agree to participate in the study and sign the consent form will be will be screened for eligibility. Participants will be randomized 1:1 to two arms: Arm A will be asked to download a mobile application called CancerLife. CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team. Participants will be provided with online or printed instructions on the use of CancerLife and receive a user guide that they can refer on demand. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider. Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures. Participants in Arm A will be asked to register on CancerLife to start using the broadcasting feature of the app. In addition, they will be asked to complete a series of questions through CancerLife at baseline and every 3 months for up to 2 years. Participants in Arm A will also be asked to complete FACT-G, GAD-7, DST, and QQPPI at those timepoints. Participants in Arm B will receive usual care provided for in the clinics. They will also be asked to complete the FACT-G, GAD-7, DST, and QQPPI at baseline and every 3 months for up to 2 years..

Official Title
-----------------
Patient-Driven Solution in Cancer Care: Improving Outcomes Using a Digital Information and Communication Platform

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: CancerLife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Diagnosis of cancer Receiving systemic treatment (chemotherapy, biotherapy/immunotherapy, hormonal therapy) that is expected to continue for at least 3 treatment sessions (approximately 9 weeks) from the time of enrollment Karnofsky Index ≥50% Able to understand and sign informed consent Owns and able to use an electronic communication device (smart phone, tablet, laptop, desktop) and answer simple self-report questionnaires on their own Exclusion Criteria: Relevant cognitive impairment Participating in a therapeutic clinical trial Unable to read and comprehend English language text

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CancerLife<br>Arm A will be asked to download a mobile application called CancerLife. CancerLife is a stand-alone application that is NOT integrated into the patient's electronic health record and will NOT trigger symptom alerts to the treatment team. Participants will be instructed to use the after-visit instructions provided to them by their treatment team for any symptoms or conditions that will require an evaluation by a healthcare provider. | Other: CancerLife<br>* CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team.<br>|
| No Intervention: Usual care<br>Arm B will receive usual care provided for in the clinics. Usual care may vary between institutions, practices, and providers. Usual care may consist of but is not limited to any combination of the following: history and physical examination, review of systems, distress screening, symptom assessment measures, and/or interval quality of life measures. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Symptoms | Reduction in severity and occurrence of symptoms | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) | Functional Assessment of Cancer Therapy-General (FACT-G): subscale scores are added to derive total FACT-G score (0-108). The higher the score, the better the QOL. | 2 years | 
| Anxiety | Generalized Anxiety Disorder 7-item (GAD-7) scale: score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. | 2 years | 
| Depression | Depression Screening Tool (DST): score ranges from 0-6, patient with scores of >3 should be further evaluated with other diagnostic instruments. | 2 years | 
| Emotional state | Tone analyzer and sentiment analysis using IBM Watson | 2 years | 
| Quality of Physician-Patient Interaction | Questionnaire on the Quality of Physician-Patient Interaction (QQPPI): 14 items with each item ranging from 1-5, higher scores indicating more favorable ratings | 2 years | 
| Emergency department visits/hospitalizations | Frequency of emergency department visits/hospitalizations | 2 years |