Clinical trial NCT03371147: CancerLife: Patient-Driven Solution in Cancer Care
Official title: Patient-Driven Solution in Cancer Care: Improving Outcomes Using a Digital Information and Communication Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
Collaborators: name: Healthy Platforms, LLC
First posted: 2017-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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..

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

Primary outcomes:
measure: Self-Reported Symptoms
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: 2 years
measure: Anxiety
timeFrame: 2 years
measure: Depression
timeFrame: 2 years
measure: Emotional state
timeFrame: 2 years
measure: Quality of Physician-Patient Interaction
timeFrame: 2 years
measure: Emergency department visits/hospitalizations
timeFrame: 2 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Santosh Kesari, MD PhD
role: STUDY_CHAIR
affiliation: John Wayne Cancer Institute at Providence Saint John's Health Center
name: Marlon G Saria, PhD RN FAAN
role: PRINCIPAL_INVESTIGATOR
References: