Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

NCT05499663 | Completed Phase 1 Results DMC

• 2 other identifiers: HP-0010047375N91021C00019-0-9999-1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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. All participants will be asked to download the POSTHOC app to assess technical compatibility and for data collection purposes (i.e., step count via Fitbit, ecological momentary assessment). All participants will have a "lite" version of the app for baseline. Upon randomization, 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. These features will also become accessible in the app. 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

Keywords

mobile health; mhealth; exercise; nutrition; behavior change

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Logged Data at Least Three Times in the POSTHOC App

  Number of participants who logged data at least three times in the POSTHOC app

  12 weeks

• Usefulness of POSTHOC App

  7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful

  6 weeks

• Usefulness of POSTHOC App

  7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful

  12 weeks

• Likely to Recommend the POSTHOC App

  7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely

  6 weeks

• Likely to Recommend the POSTHOC App

  7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely

  12 weeks

Secondary Outcomes (2)

• Cumulative Symptom Burden

  6 weeks

• Cumulative Symptom Burden

  12 weeks

Study Arms (2)

POSTHOC app

EXPERIMENTAL

Behavioral: POSTHOC app

Control

NO INTERVENTION

Interventions

POSTHOC app 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

POSTHOC app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have planned surgery, radiotherapy, or surgery during the study period (hormonal and biologic therapy is allowed)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator
• Charles River Analytics: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• James S, Clingan CL, Adesanya IA, Zhu S, Francis ME, Rosenblatt PY, Molitoris JK, Deighton DC, Winder AT, Desrochers PC, McGeorge NM, Kleckner IR, Kleckner AS. Leveraging technology to address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC): A phase I/II randomized controlled trial of a survivorship care plan mobile application. J Cancer Surviv. 2025 Nov 27:10.1007/s11764-025-01946-7. doi: 10.1007/s11764-025-01946-7. Online ahead of print.

  PMID: 41307872 DERIVED

• 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.

  PMID: 39235855 DERIVED

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms; Motor Activity

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

For 10 consented participants, app download was unsuccessful.

Results Point of Contact

• Title: Amber Kleckner
• Organization: University of Maryland School of Nursing

amber.kleckner@umaryland.edu

4107065961

Study Officials

• Amber Kleckner, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: March 5, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 20, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)