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

54 Participants Needed

Trial Summary

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 data supports the idea that POSTHOC App for Cancer Survivors is an effective treatment?

The available research shows that app-based treatments, like the POSTHOC App for Cancer Survivors, are promising for improving the care of cancer survivors. One study highlights the feasibility of using an app-based care plan for breast cancer survivors, suggesting that such apps can be integrated into routine care. Another review indicates that smartphone applications can support and empower cancer survivors, potentially improving their quality of life. While specific data on the POSTHOC App itself isn't detailed, these studies suggest that similar app-based treatments are effective in supporting cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the POSTHOC app treatment for cancer survivors?

Research shows that app-based care plans and smartphone applications can help cancer survivors by improving their quality of life and supporting self-management of symptoms. These tools are feasible to integrate into routine follow-up care and can empower survivors during post-treatment. ^{1 2 3 4 5}

What safety data exists for the POSTHOC app for cancer survivors?

The available research does not provide specific safety data for the POSTHOC app. However, studies on similar mobile health apps for cancer survivors indicate that these apps are generally feasible, usable, and acceptable. For example, the Health Storylines app was rated favorably for usability among adult oncology patients, and web-based platforms like Passport for Care show potential for improving access to health information. These findings suggest that mobile health apps can be safely integrated into post-treatment care, although specific safety data for the POSTHOC app is not detailed in the provided research. ^{1 2 6 7 8}

Is the POSTHOC app safe for cancer survivors?

The available research suggests that similar mobile health apps, like the Health Storylines app, are generally safe and well-received by cancer patients, with most users finding them easy to use and acceptable. ^{1 2 6 7 8}

Is the POSTHOC app a promising treatment for cancer survivors?

Yes, the POSTHOC app is a promising treatment for cancer survivors. 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, and sleep issues. These apps can be easily integrated into routine care, making them a valuable tool for self-management after cancer treatment. ^{2 3 6 9 10}

How is the POSTHOC app treatment different from other treatments for cancer survivors?

The POSTHOC app is unique because it is a mobile application designed to support cancer survivors in managing their health after treatment, focusing on improving quality of life and self-management without needing direct healthcare provider involvement. Unlike traditional treatments, it empowers users by providing personalized feedback and support through a digital platform. ^{2 3 6 9 10}

What is the purpose of this trial?

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.

Research Team

Amber Kleckner, PhD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review of smartphone applications for cancer survivors. [2023]

3. England 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. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Prospective trial on telemonitoring of geriatric cancer patients using handheld devices. [2022]

5. Netherlands 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. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Improving Childhood Cancer Survivor Care Through Web-Based Platforms. [2018]

8. United States 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Achieving value in mobile health applications for cancer survivors. [2021]

10. United States 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. [2020]