| Condition or disease | Intervention/treatment |
|---|---|
| Cancer, Breast Cancer of Colon Cancer of Rectum Cancer | Device: Plan to Thrive smartphone application |
| Study Type : | Observational |
| Actual Enrollment : | 33 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic Using a Smartphone-enabled Monitoring, Navigation and Tailored Intervention Program |
| Actual Study Start Date : | August 19, 2019 |
| Actual Primary Completion Date : | December 23, 2019 |
| Actual Study Completion Date : | December 31, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
Device: 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.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Sofia F Garcia, Ph.D. | Northwestern University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 19, 2019 | ||||
| First Posted Date | June 24, 2019 | ||||
| Last Update Posted Date | September 9, 2020 | ||||
| Actual Study Start Date | August 19, 2019 | ||||
| Actual Primary Completion Date | December 23, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures |
|
||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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]. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment. | ||||
| Condition |
|
||||
| Intervention | Device: 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.
|
||||
| Study Groups/Cohorts | 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.
Intervention: Device: Plan to Thrive smartphone application
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
33 | ||||
| Original Estimated Enrollment |
40 | ||||
| Actual Study Completion Date | December 31, 2019 | ||||
| Actual Primary Completion Date | December 23, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03996031 | ||||
| Other Study ID Numbers | STU00209558 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Sofia Garcia, Northwestern University | ||||
| Study Sponsor | Northwestern University | ||||
| Collaborators | Vignet, Inc. | ||||
| Investigators |
|
||||
| PRS Account | Northwestern University | ||||
| Verification Date | September 2020 | ||||