WCM App for Cancer Survivors

Overseen By Susan Magasi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Active treatment, No cancer diagnosis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app, WCM, designed to assist cancer survivors with disabilities. The goal is to determine if the app is user-friendly, satisfies users, and effectively supports health management. It targets individuals who have completed active treatment for breast cancer, head and neck cancer, or sarcoma and who self-identify as having a disability due to long-term effects of their cancer or its treatment. Participants must have internet access and a device such as a smartphone, tablet, or computer. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for managing health after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants may still be undergoing endocrine or hormone therapies, suggesting that some medications might be allowed.

What prior data suggests that the WCM app is safe for cancer survivors with disabilities?

Research has shown that the WCM app helps cancer survivors manage their health independently. This mobile health app aims to enhance the quality of life for cancer survivors with disabilities.

The Data Safety and Monitoring Committee regularly reviews the app to ensure its safety and proper functioning. While specific safety details about the WCM app are not provided, the committee's involvement underscores the priority placed on safety.

The absence of a specific phase for this study indicates that the treatment remains in early testing stages. This may suggest limited safety data, but structured oversight helps protect participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WCM app for cancer survivors because it offers a unique approach to managing life after cancer treatment. Unlike traditional methods that might focus on periodic doctor visits or support groups, this app empowers survivors by providing personalized tools and resources directly on their smartphones. It allows users to track their progress and manage their health through interactive questionnaires like PROMIS and the Self Efficacy scale, which can help them gain better control over their well-being. This digital approach makes support more accessible and tailored to individual needs, potentially enhancing recovery and quality of life for cancer survivors.

What evidence suggests that the WCM app is effective for cancer survivors with disabilities?

Research has shown that smartphone apps can help cancer survivors take better care of their health. The WCM app, which participants in this trial will evaluate, is designed to help cancer survivors with disabilities manage their health independently. Early results suggest that these apps can improve quality of life by helping users track symptoms, manage stress, and adhere to treatment plans. Studies also indicate that these tools can enhance users' confidence in managing their health. While specific data on the effectiveness of the WCM app is still being collected, similar tools have shown promise. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for cancer survivors aged 18 or older who have finished active treatment for breast cancer, head and neck cancer, or sarcoma. Participants must self-identify as having disabling after-effects of cancer per the Americans with Disabilities Act, be medically stable to engage in two data collection sessions totaling 2 hours, and communicate in English.

Inclusion Criteria

You consider yourself to have a disability as defined by the Americans with Disabilities Act and the American Community Survey's 6 disability questions.

I consider myself disabled due to cancer or its treatment.

This criterion refers to the process of testing the high-quality version of the WeCanManage prototype to see how easy and practical it is to use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the WeCanManage app for self-management intervention

8 weeks

Baseline evaluation, completion evaluation, and 4-week post-completion evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WCM app

Trial Overview The WeCanManage (WCM) app is being tested for its feasibility, acceptability, user satisfaction, response patterns and preliminary efficacy on patient-reported outcomes among cancer survivors with disabilities using a pre-post single arm design.

How Is the Trial Designed?

Group I: WCM app Experimental Treatment 1 Intervention

WCM app evaluation at baseline, upon completion of WCM program and 4 weeks after completion of WCM program, by completing PROMIS and Self Efficacy for managing disease scale questionnaires

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Northeastern Illinois University

Collaborator

Trials

3

Recruited

850+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The Assisted Radiation Oncology Mobile Application (AROMA) was developed to improve communication between patients and radiation oncologists, and it received a high satisfaction rating of 8.6 out of 10 from users, indicating its potential effectiveness.

In a study involving 41 patients, the application was particularly praised for its side effect reporting function (94% positive feedback) and overall communication capabilities (91% positive feedback), suggesting it could enhance patient management during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Integrated Mobile Application System for Patients with Radiation Therapy: A Pilot Study. Park, J., Yea, JW., Oh, SA., et al.[2022]

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]

General practitioners (GPs) in the Netherlands expressed a desire to be more involved in the survivorship care of colon cancer patients, indicating that they are aware of the importance of monitoring for recurrent disease and maintaining contact with patients post-treatment.

The eHealth application Oncokompas(2.0) was viewed positively by GPs as a useful tool for enhancing self-management in survivorship care, particularly for younger and more educated patients, suggesting that digital health solutions can play a role in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care-led survivorship care for patients with colon cancer and the use of eHealth: a qualitative study on perspectives of general practitioners. Duineveld, LA., Wieldraaijer, T., Wind, J., et al.[2019]

A systematic review of 54 articles over the last 10 years found that mobile apps for cancer management are increasingly being researched, particularly for early detection, with a focus on melanoma.

Despite the growth in studies, many of the apps developed for cancer management tend to be removed from app stores after the research is completed, making it difficult for users to access them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications in oncology: A systematic review of health science databases. Ana, FA., Loreto, MS., José, LM., et al.[2020]

A study involving 4475 breast cancer patients showed that using a smartphone app significantly improved adherence to multidisciplinary treatment (MDT) recommendations, with a notable reduction in noncompliance rates from 27.4% in 2013 to 8.8% in 2019.

Patients who used the app were 39% less likely to deviate from MDT recommendations compared to those who did not use the app, particularly improving compliance with adjuvant chemotherapy and radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. Yu, J., Wu, J., Huang, O., et al.[2021]

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 web-based survivorship care plan application (SCP-A) significantly reduced unmet needs and fear of recurrence in women with breast cancer over a 12-month period, as shown by a study involving 165 participants.

Women using the SCP-A reported improved quality of life compared to those in the control group, indicating that such digital tools can be effective in supporting breast cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study. Fang, SY., Wang, YL., Lu, WH., et al.[2020]

The OncoKompas online self-management application was found to be feasible for cancer survivors, with a 64% adoption rate and a 75-91% implementation rate, indicating that many participants used the app as intended.

Participants reported a mean satisfaction score of 7.3 out of 10, suggesting that while OncoKompas is effective, there is room for improvement in user experience and personalization to enhance its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an eHealth application "OncoKompas" to improve personalized survivorship cancer care. Duman-Lubberding, S., van Uden-Kraan, CF., Jansen, F., et al.[2022]

A randomized controlled trial will assess the efficacy and cost-utility of the eHealth self-management application Oncokompas for 544 cancer survivors, focusing on improving patient activation and overall quality of life.

The study aims to evaluate how well Oncokompas reaches cancer survivors and its impact on various outcomes, including self-efficacy and perceived patient-physician interaction, over a follow-up period of 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial. van der Hout, A., van Uden-Kraan, CF., Witte, BI., et al.[2018]

A study involving 134 breast cancer women and their general practitioners showed that 85% of survivors found the survivorship care plan (SCP) binders useful, highlighting their importance in providing comprehensive post-cancer care information.

General practitioners also valued the SCP letters, with 38% using the information to facilitate patient care transitions, indicating that SCPs can enhance communication and long-term surveillance for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survivorship care plan (SCP) : The viewpoints of women with breast cancer and their general practitioners]. Ladaique, AF., Desandes, E., Salleron, J., et al.[2021]

A randomized controlled trial involving cancer patients receiving outpatient chemotherapy showed that daily text messages with self-care guidelines significantly reduced the overall side effects experienced by patients in the intervention group compared to the control group during the first cycle of treatment.

Patients in the intervention group also reported less nausea during both the first and second cycles of chemotherapy, suggesting that text messaging can be an effective tool for managing side effects in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Text Messaging (SMS) for the Management of Side Effects in Cancer Patients Undergoing Chemotherapy Treatment: a Randomized Controlled Trial. Rico, TM., Dos Santos Machado, K., Fernandes, VP., 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]

Citations

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WCM App for Cancer Survivors What data supports the effectiveness of the WCM app treatment for cancer survivors? Research shows that smartphone apps can help cancer survivors by ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06185738

WeCanManage. An mHealth Self-management Tool Using a pre-post, single arm feasibility design with cancer survivors with disabilities, we will collect data on the WeCanManage app delivered self-management ...

3. phs.weill.cornell.edu phs.weill.cornell.edu/news/ai-tool-accurately-sorts-cancer-patients-their-likely-outcomes

AI Tool Accurately Sorts Cancer Patients by Their Likely ... A new artificial intelligence-based method accurately sorts cancer patients into groups that have similar characteristics before treatment and ...

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WeCanManage. An mHealth Self-management Tool Examine the Feasibility, Acceptability, User Satisfaction, and Response Patterns and Preliminary Efficacy on Targeted Patient Reported ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364172/

Developing an mHealth App for Empowering Cancer ... This study aims to design an mHealth app for cancer survivors with disabilities that will offer interventions to improve their quality of life and increase ...

6. hrp.weill.cornell.edu hrp.weill.cornell.edu/regulatory-compliance/data-safety-and-monitoring-committee-dsmc

Data Safety and Monitoring Committee (DSMC) It performs a regular review of cumulative data to evaluate research subject safety, rates of accrual, and efficacy of experimental intervention.

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wcm_dsmc_data_and_safety_m... All interventional cancer trials, regardless of sponsor, submitted to the MCC Protocol Review Monitoring Committee (PRMC) must include a Data and Safety ...

8. researchgate.net researchgate.net/publication/361513829_Developing_an_mHealth_Application_for_Empowering_Cancer_Survivors_with_Disabilities_A_Co-Design_Approach_Preprint

(PDF) Developing an mHealth Application for Empowering ... Objective: This study aims to design an mHealth app for cancer survivors with disabilities that will offer interventions to improve their quality of life and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6754682/

Mobile Health Divide Between Clinicians and Patients in ... This study aimed to describe the patient and clinician population that uses mHealth in cancer care and to provide recommendations to app developers and ...