POSTHOC App for Cancer Survivors

(POSTHOC Trial)

Overseen By Amber Kleckner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Planned surgery, radiotherapy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new app called POSTHOC, designed to help cancer survivors manage symptoms and recovery after treatment. The app aims to make Survivorship Care Plans, which guide post-treatment recovery, more accessible and easier to update than traditional paper versions. Participants who completed treatments like chemotherapy or surgery in the last 12 weeks and have a smartphone can join. The goal is to determine if the app improves symptom management and recovery compared to usual care. Participants will focus on either nutrition or exercise, and researchers will track and compare their progress. As a Phase 1 and Phase 2 trial, this research seeks to understand how the app functions in people and measure its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, hormonal and biologic therapy is allowed during the study period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an app to manage your health after cancer treatment, so it's best to discuss your medications with the trial team or your doctor.

What prior data suggests that the POSTHOC app is safe for cancer survivors?

Research has shown that similar mobile health apps for cancer survivors are generally well-received. Although specific safety data for the POSTHOC app is not yet available, studies on other digital health tools have reported few negative effects. Most users find these apps easy to use and helpful for managing their health after cancer treatment. As the trial for the POSTHOC app is in its early stages, the focus remains on assessing its safety and effectiveness. However, the positive safety record of similar apps offers hope that it will benefit cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The POSTHOC app is unique because it offers a digital approach to support cancer survivors, which is different from traditional follow-up care typically involving in-person visits and consultations. Researchers are excited about this app because it leverages technology to provide personalized health monitoring and support, potentially improving the quality of life for survivors. Unlike standard treatments that focus solely on physical health, the app may also address mental and emotional well-being, offering holistic care.

What evidence suggests that the POSTHOC app is effective for cancer survivors?

Research has shown that mobile health apps like POSTHOC, available to participants in this trial, can help cancer survivors manage symptoms such as pain and fatigue. Early results suggest that using apps like POSTHOC to organize Survivorship Care Plans can enhance quality of life and self-care. These apps allow users to track their health habits and compare them with medical goals. They simplify patient engagement by providing current information and personalized advice. POSTHOC aims to empower users to take control of their recovery by focusing on important lifestyle changes like healthy eating and regular exercise. ^{1 2 3 4 5}

Who Is on the Research Team?

Amber Kleckner, PhD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for cancer survivors who've recently finished treatment like chemo, radiotherapy, or surgery. They should be open to following a Survivorship Care Plan and have access to a smartphone with internet. Participants must be adults who can read English and consent to the study.

Inclusion Criteria

I am willing to follow a Survivorship Care Plan as advised by my healthcare provider.

I recently finished or will soon finish a treatment aimed at curing my cancer.

Be able to read and understand English

Exclusion Criteria

I am not planning any surgery or radiotherapy during the study, but may continue hormonal or biologic therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the POSTHOC app as part of the Survivorship Care Plan for 12 weeks, focusing on nutrition or exercise

12 weeks

Baseline, 6 weeks, and 12 weeks evaluations

Follow-up

Participants are monitored for symptom burden and app usability feedback is collected

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• POSTHOC app

Trial Overview The POSTHOC app is being tested against usual care plans in managing symptoms after cancer treatment. The app digitizes care plans and integrates them with health trackers. Patients will focus on nutrition or exercise goals over 12 weeks.

How Is the Trial Designed?

Group I: POSTHOC app Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Charles River Analytics

Industry Sponsor

Trials

4

Recruited

150+

Published Research Related to This Trial

Childhood cancer survivors often do not fully understand their health risks related to cancer treatment, with a survey of 528 participants showing many are unaware of late effects and less fearful of recurrence compared to their parents.

Web-based platforms like Passport for Care can significantly improve access to health information and awareness about late effects of cancer treatment, potentially enhancing adherence to follow-up care and facilitating further research on survivor health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Childhood Cancer Survivor Care Through Web-Based Platforms. Gramatges, MM., Bonaduce de Nigris, F., King, J., et al.[2018]

In a feasibility study involving 54 elderly cancer patients, 29 activated and used a smartphone app for follow-up, showing an average compliance rate of 58.3% over 4 months, with daily compliance declining over time.

The app-based questionnaires, including the EORTC-QLQ-C30, were well-accepted, and there was a significant correlation between patients' self-reported health status and physician-rated performance status, suggesting the app could effectively monitor patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective trial on telemonitoring of geriatric cancer patients using handheld devices. Buergy, D., Siefert, V., Neumaier, C., et al.[2022]

The pilot study involving 23 female breast cancer survivors demonstrated that an app-based interactive care plan (ICP) was feasible, allowing for remote monitoring and symptom management, although patient engagement fell short of the desired 75% completion rate for tasks.

Despite the initial feasibility, with all patients engaging in at least one task, the decreasing completion rates over time indicate a need for strategies to improve ongoing patient engagement and enhance the effectiveness of the ICP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. Stan, DL., Inselman, JW., Ridgeway, JL., et al.[2022]

In a 2-week trial involving 32 adult radiation oncology patients, the Health Storylines app demonstrated favorable usability, with 81% of participants finding it easy to use.

The app was accessed a total of 711 times, indicating a high level of engagement among users, which suggests that mobile health tracking apps may be well-received in clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usability and Acceptability of a Patient-Centered Mobile Health Tracking App Among a Sample of Adult Radiation Oncology Patients. Birkhoff, SD., Cantrell, MA., Moriarty, H., et al.[2019]

The Oncokompas web-based eHealth application, designed to help cancer survivors manage their health-related quality of life and symptoms, did not significantly improve patient activation (knowledge, skills, and confidence for self-management) compared to a control group in a study involving 625 cancer survivors.

Despite the lack of improvement in self-management skills, this study highlights the need for tailored strategies in developing and implementing behavioral intervention technologies for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial. van der Hout, A., van Uden-Kraan, CF., Holtmaat, K., et al.[2020]

In a pilot study involving 26 female childhood cancer survivors, the Health Storylines mHealth app was used frequently, with some participants accessing it up to 902 times, but overall, there were no statistically significant improvements in self-efficacy, perceived illness, or health-related quality of life after 3 or 6 months of use.

The study highlighted that while the app's mental health component was utilized by all participants, the effectiveness varied significantly between high and low users, suggesting that further research is needed to identify which individuals benefit most from such mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effect of the Health Storylines mHealth App on Female Childhood Cancer Survivors' Self-efficacy, Health-Related Quality of Life and Perceived Illness. Cantrell, MA., Ruble, K., Mensinger, J., et al.[2022]

The ConnectedCancerCare (CCC) intervention was found to be feasible and acceptable for women with early-stage breast cancer, with 82% of participants finding it easy to use and 86% willing to recommend it to others.

Women using CCC were more likely to schedule follow-up visits with their primary care provider and had better communication about provider roles, indicating that CCC may enhance patient engagement and knowledge in team-based cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. Wallner, LP., Abrahamse, P., Gargaro, JG., et al.[2023]

A review of 23 studies found that mobile phone applications are feasible and acceptable tools for supporting cancer survivors during their transition from active treatment to follow-up care, particularly in promoting health through exercise and dietary changes.

Despite the potential benefits, the review highlighted a lack of robust evidence from randomized controlled trials (only three identified), indicating a need for more rigorous studies to better understand the effectiveness of these apps in improving quality of life and self-reported outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of smartphone applications for cancer survivors. Changrani, K., Chima, S., Sharma, A., et al.[2023]

Mobile health applications for cancer survivors have significant potential to empower patients and improve their survivorship experience, but many currently lack rigorous development and testing standards.

Only a few apps incorporate essential empowerment elements and user-centered design, which limits their effectiveness; standardized procedures could enhance their value for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving value in mobile health applications for cancer survivors. Davis, SW., Oakley-Girvan, I.[2021]

mHealth applications have shown promise in improving pain and fatigue outcomes for cancer survivors, with three out of four studies reporting positive results for pain and four studies indicating improvements in fatigue.

While there is some evidence for benefits in psychological distress and sleep outcomes, the results were mixed, highlighting the need for further development and targeted approaches in mHealth interventions for cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. Hernandez Silva, E., Lawler, S., Langbecker, D.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11413545/

Digitizing Survivorship Care Plans Through the POST ... A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39235855

Protocol for a Phase II Randomized Controlled Trial - PubMed Objective: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03376

POSTHOC Survivorship Care Plan Mobile Application to ... This clinical trial compares the effects of the standard paper-based Survivorship Care Plan versus (vs.) a new smartphone application (app), POST-treatment ...

4. withpower.com withpower.com/trial/phase-2-signs-and-symptoms-10-2022-7efbc

POSTHOC App for Cancer Survivors · Info for Participants Mobile health apps like POSTHOC can support and empower cancer survivors by improving their quality of life and helping them manage symptoms like pain, fatigue, ...

5. mdpi.com mdpi.com/2076-3417/15/9/4713

Evaluating the Benefits and Implementation Challenges of ... Evaluating the benefits and implementation challenges of digital health interventions for improving self-efficacy and patient activation in cancer survivors.