NCT03371147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

December 7, 2017

Last Update Submit

February 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Symptoms

    Reduction in severity and occurrence of symptoms

    2 years

Secondary Outcomes (6)

  • Quality of Life (QOL)

    2 years

  • Anxiety

    2 years

  • Depression

    2 years

  • Emotional state

    2 years

  • Quality of Physician-Patient Interaction

    2 years

  • +1 more secondary outcomes

Study Arms (2)

CancerLife

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

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.

CancerLife

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Relevant cognitive impairment
  • Participating in a therapeutic clinical trial
  • Unable to read and comprehend English language text

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Santosh Kesari, MD PhD

    Saint John's Cancer Institute

    STUDY CHAIR
  • Marlon G Saria, PhD RN FAAN

    John Wayne Cancer Institute at Providence Saint John's Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

March 15, 2018

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations