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CancerLife: Patient-Driven Solution in Cancer Care

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ClinicalTrials.gov Identifier: NCT03371147
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Healthy Platforms, LLC
Information provided by (Responsible Party):
John Wayne Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Cancer Other: CancerLife Not Applicable

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..


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient-Driven Solution in Cancer Care: Improving Outcomes Using a Digital Information and Communication Platform
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : January 17, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: CancerLife
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
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.

No Intervention: Usual care
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.



Primary Outcome Measures :
  1. Self-Reported Symptoms [ Time Frame: 2 years ]
    Reduction in severity and occurrence of symptoms


Secondary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: 2 years ]
    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. Anxiety [ Time Frame: 2 years ]
    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.

  3. Depression [ Time Frame: 2 years ]
    Depression Screening Tool (DST): score ranges from 0-6, patient with scores of >3 should be further evaluated with other diagnostic instruments.

  4. Emotional state [ Time Frame: 2 years ]
    Tone analyzer and sentiment analysis using IBM Watson

  5. Quality of Physician-Patient Interaction [ Time Frame: 2 years ]
    Questionnaire on the Quality of Physician-Patient Interaction (QQPPI): 14 items with each item ranging from 1-5, higher scores indicating more favorable ratings

  6. Emergency department visits/hospitalizations [ Time Frame: 2 years ]
    Frequency of emergency department visits/hospitalizations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371147


Contacts
Contact: Marlon G Saria, PhD, RN 3105827340 familycaregivers@providence.org

Locations
United States, California
John Wayne Cancer Institute at Providence Saint John's Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Marlon G. Saria, PhD, RN       familycaregivers@providence.org   
Sponsors and Collaborators
John Wayne Cancer Institute
Healthy Platforms, LLC
Investigators
Study Chair: Santosh Kesari, MD, PhD John Wayne Cancer Institute

Responsible Party: John Wayne Cancer Institute
ClinicalTrials.gov Identifier: NCT03371147     History of Changes
Other Study ID Numbers: JWCI-17-1001
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No