Clinical trial NCT03996031: Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic
Official title: Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic Using a Smartphone-enabled Monitoring, Navigation and Tailored Intervention Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Breast
Cancer of Colon
Cancer of Rectum
Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Vignet, Inc.
First posted: 2019-06-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment.

Brief summary: The purpose of this study is to test the usability of the Plan To Thrive smartphone application with cancer survivors. This study will involve three visits (baseline, follow-up, and feedback assessments). Between the baseline and follow-up time points, patients will undergo a 90-day period in which they will engage with app content. It is hypothesized that cancer survivors in this study will find the smartphone application, Plan to Thrive, an acceptable and feasible way to access post-treatment information. In addition, the investigators will explore preliminary efficacy by examining changes over time in primary (patient activation, patient knowledge and adherence to follow-up care recommendations and health behaviors) and secondary outcomes \[symptom burden, health-related quality of life and patient satisfaction\].


Eligibility criteria: INCLUSION CRITERIA:

* At least 18 years of age or older
* Prior history of cancer
* Completion of primary cancer treatment (i.e., surgery, chemotherapy and/or radiation; but can be receiving hormonal treatment)
* Have an e-mail account and reliable broadband access to the Internet
* Able to read, understand, and speak English sufficiently to understand study questionnaires and consent form

EXCLUSION CRITERIA:

* Has a medical condition with a life expectancy of fewer than 12 months
* Physical or cognitive disability that would prohibit them from participating in study procedures
* Having prior inpatient psychiatric treatment, or overt signs of, severe psychopathology (e.g., psychosis, substance dependence, suicidality)

Primary outcomes:
measure: Rate of enrollment
timeFrame: 4 months (baseline to follow-up)
measure: Rate of retention
timeFrame: 4 months (baseline to follow-up).
measure: Rate of app usage
timeFrame: 4 months (baseline to follow-up).
measure: Patient knowledge and adherence to follow-up care recommendations and health behaviors
timeFrame: 4 months (baseline to follow-up).
measure: Patient activation
timeFrame: 4 months (baseline to follow-up).
Secondary outcomes:
measure: Symptom burden
timeFrame: 4 months (baseline to follow-up).
measure: Health-related quality of life (HRQoL)
timeFrame: 4 months (baseline to follow-up).
measure: Patient satisfaction
timeFrame: 4 months (baseline to follow-up).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: Northwestern University
name: Sofia F Garcia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: