Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

NCT ID: NCT05499663

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2028-07-31

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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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

Conditions

Survivorship; Cancer; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

POSTHOC app

Group Type: EXPERIMENTAL

POSTHOC app

Intervention Type: BEHAVIORAL

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Charles River Analytics

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Amber Kleckner

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber Kleckner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland, Baltimore

Baltimore, Maryland, United States

Countries

United States

References

Chung KH, Youngblood SM, Clingan CL, Deighton DC, Jump VA, Manuweera T, McGeorge NM, Renn CL, Rosenblatt PY, Winder AT, Zhu S, Kleckner IR, Kleckner AS. Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 5;13:e59222. doi: 10.2196/59222.

Reference Type: DERIVED

PMID: 39235855 (View on PubMed)

Other Identifiers

75N91021C00019-0-9999-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00100473

Identifier Type: -

Identifier Source: org_study_id