Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05499663
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2022-08-10
Brief Title:
Title Leveraging Technology to Address Health Outcomes of Cancer Survivors
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors POSTHOC-II A Phase II Survivorship Care Plan Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSTHOC
Brief Summary:
At the end of cancer treatment many patients are still dealing with symptoms of cancer and side effects of treatment Many are also left in a surreal mental state with uncertainty regarding the future of their health Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment ie chemotherapy surgery radiation Survivorship Care Plans describe the details of a persons diagnosis and treatment as well as provide recommendations for follow-up appointments referrals and healthy behaviors to accelerate recovery and prevent recurrence eg diet exercise smoking cessation Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the persons health status changes Therefore there is a need to digitize Survivorship Care Plans to improve the accessibility modifiability and longevity of the plan In addition with current technology there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals enabling people to take charge of their own health Charles River Analytics developed an app called POSTHOC POST-treatment Healthcare Outcomes for Cancer survivors that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record
Herein phase III feasibilitypreliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer eg chemotherapy radiotherapy surgery to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs the usual care Survivorship Care Plan on total symptom burden Participants will be randomized 21 POSTHOCusual care Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences At baseline 6 weeks and 12 weeks patient-reported outcomes will be evaluated including total symptom burden diet and physical activity Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies
Herein phase III feasibilitypreliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer eg chemotherapy radiotherapy surgery to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs the usual care Survivorship Care Plan on total symptom burden Participants will be randomized 21 POSTHOCusual care Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences At baseline 6 weeks and 12 weeks patient-reported outcomes will be evaluated including total symptom burden diet and physical activity Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 75N91021C00019-0-9999-1 | NIH | None | httpsreporternihgovquickSearch75N91021C00019-0-9999-1 |