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Trial Title:
Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors
NCT ID:
NCT05499663
Condition:
Survivorship
Cancer
Symptoms and Signs
Conditions: Keywords:
mobile health
mhealth
exercise
nutrition
behavior change
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
POSTHOC app
Description:
The POSTHOC app is a smartphone application that will deliver the Survivorship Care Plan
and promote healthy lifestyle behaviors consistent with the individual's Care Plan
Arm group label:
POSTHOC app
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 (i.e., chemotherapy,
surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis
and treatment, as well as provide recommendations for follow-up appointments, referrals,
and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet,
exercise, smoking cessation). Survivorship Care Plans are currently static documents that
are provided via paper and become outdated as soon as the person's health status changes.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 I/II feasibility/preliminary efficacy randomized controlled trial is being
conducted among 54 patients with cancer who recently completed adjuvant treatment for
cancer (e.g., 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 2:1, POSTHOC:usual 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have had a cancer diagnosis (any type)
- Will soon or have recently completed treatment (within the past 12 weeks) with
chemotherapy, radiotherapy, or surgery with curative intent
- Must have received, plans to receive, or open to receiving a Survivorship Care Plan
(SCP) as per their provider
- Have access to a device capable of running the POSTHOC app and Fitbit app (e.g.,
Android or Apple smartphone) and reliable Internet access
- Be at least 18 years of age
- Be able to read and understand English, and
- Be able to provide written informed consent
Exclusion Criteria:
- Have planned surgery, radiotherapy, or surgery during the study period (hormonal and
biologic therapy is allowed)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Maryland, Baltimore
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amber Kleckner, PhD
Phone:
410-706-5961
Email:
amber.kleckner@umaryland.edu
Start date:
March 5, 2024
Completion date:
July 2028
Lead sponsor:
Agency:
University of Maryland, Baltimore
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Charles River Analytics
Agency class:
Industry
Source:
University of Maryland, Baltimore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05499663
