Clinical trial NCT05499663: Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors
Official title: Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Survivorship
Cancer
Symptoms and Signs
Keywords: mobile health
mhealth
exercise
nutrition
behavior change
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Charles River Analytics
First posted: 2022-08-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 (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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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.


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)

Primary outcomes:
measure: Cumulative number of times participants log/view data in the app
timeFrame: 12 weeks
measure: Usefulness
timeFrame: 6 weeks
measure: Usefulness
timeFrame: 12 weeks
measure: Likely to recommend
timeFrame: 6 weeks
measure: Likely to recommend
timeFrame: 12 weeks
Secondary outcomes:
measure: Cumulative Symptom Burden
timeFrame: 6 weeks
measure: Cumulative Symptom Burden
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Amber Kleckner, PhD
role: PRINCIPAL_INVESTIGATOR
References: