Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic

NCT ID: NCT03996031

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2019-12-31

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].

Conditions

Cancer, Breast; Cancer of Colon; Cancer of Rectum; Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Sample

All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests. Following the baseline assessment, participants will engage with the Plan to Thrive app for a 90-day period.

Plan to Thrive smartphone application

Intervention Type: DEVICE

All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests.

Interventions

Plan to Thrive smartphone application

All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vignet, Inc.

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Sofia Garcia

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sofia F Garcia, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00209558

Identifier Type: -

Identifier Source: org_study_id