Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

Cancer Clinical Trial

— POSTHOC  

Official title:

Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499663
• Other study ID #: HP-00100473
• Secondary ID: 75N91021C00019-0
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 5, 2024
• Est. completion date: July 2028

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: Amber Kleckner, PhD
• Phone: 410-706-5961
• Email: amber.kleckner[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Survivorship
• Symptoms and Signs

Intervention

Behavioral:
• POSTHOC app
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

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Charles River Analytics, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number of times participants log/view data in the app	The number of times participants log/view data in the app will be counted over the 12-week study	12 weeks
Primary	Usefulness	7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful	6 weeks
Primary	Usefulness	7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful	12 weeks
Primary	Likely to recommend	7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely	6 weeks
Primary	Likely to recommend	7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely	12 weeks
Secondary	Cumulative Symptom Burden	sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. A higher score indicates higher symptom burden	6 weeks
Secondary	Cumulative Symptom Burden	sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. A higher score indicates higher symptom burden	12 weeks