NCT03094741

Brief Summary

The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).

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 Apr 2017

Typical duration for not_applicable cancer

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

March 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

March 21, 2017

Last Update Submit

February 8, 2021

Conditions

CancerCaregiversQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Feasibility/ Participation Rate

    number of individuals who participate in the study divided by the number of individuals who opened the link

    4 weeks

Secondary Outcomes (5)

  • Open Rate

    4 weeks

  • Refusal rate

    4 weeks

  • Retention rate

    4 weeks

  • Rate of missing data

    4 weeks

  • Participant Satisfaction

    4 weeks

Study Arms (1)

CancerLife Feasibility Group

EXPERIMENTAL

Participants will be recruited through advertisements targeted to a specific audience using the keywords cancer and cancer survivors

Other: CancerLife

Interventions

CancerLifeOTHER

CancerLife is a mobile digital solution that allows patients to broadcast their health status inside a private invitation only group, text, email or publicly in Facebook or Instagram. By doing, so the patient collects his/her own patient-reported outcomes data and then share this data with their doctor or care team.

CancerLife Feasibility Group

Eligibility Criteria

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

You may qualify if:

  • Established diagnosis of cancer
  • Karnofsky Index ≥50%
  • Age \> 18 years

You may not qualify if:

  • Relevant cognitive impairment
  • Insufficient knowledge of English language to complete the survey

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 29, 2017

Study Start

April 1, 2017

Primary Completion

September 4, 2020

Study Completion

November 5, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)