Mobile Chatbot Support for Cancer Survivor Care

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Thyroid cancer, Skin cancers

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a chatbot called 'Penny' to help cancer survivors who haven't had follow-up care in a long time. 'Penny' sends text reminders to schedule and attend medical appointments, aiming to reengage these patients with the healthcare system.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Penny, Penny Chatbot, Mobile Chatbot Support for cancer survivor care?

Research on similar eHealth interventions, like the My Guide app for Hispanic breast cancer survivors, suggests that smartphone applications can improve quality of life and reduce cancer-specific distress by providing psychoeducation and self-management support. ^{1 2 3 4 5}

Is the Mobile Chatbot Support for Cancer Survivor Care safe for humans?

The research articles do not provide specific safety data for the Mobile Chatbot Support for Cancer Survivor Care, but they do mention the use of mobile apps and chatbots for managing symptoms and supporting cancer patients, which suggests these technologies are generally considered safe for use in humans. ^{1 6 7 8 9}

How is the Mobile Chatbot Support for Cancer Survivor Care treatment different from other treatments for cancer survivors?

The Mobile Chatbot Support for Cancer Survivor Care is unique because it provides personalized support and information through a mobile app, which is more accessible and tailored compared to traditional in-person care. This approach aims to enhance self-efficacy, social support, and symptom management, improving the quality of life and psychological well-being of cancer survivors. ^{10 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for adult survivors of childhood and young adult cancers (diagnosed from birth to age 39) who haven't had follow-up care in over 3 years. Participants must own a mobile device capable of SMS texts, speak English, consent to the study, and have their oncology team's approval.

Inclusion Criteria

Approval of the patient's oncology care team for the patient to be involved in the study

Patient possession of a mobile device that can receive SMS texts

Ability to respond to questions and engage with 'Penny' in English

Exclusion Criteria

Patients who do not meet the inclusion criteria

I have a history of thyroid cancer.

I have had skin cancer in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the Penny chatbot to schedule follow-up appointments, labs, scans, and specialty appointments

16 weeks

Follow-up

Participants are monitored for engagement and compliance with scheduled follow-up care appointments

1 year

Treatment Details

Interventions

• Penny (Behavioral Intervention)

Trial Overview The study tests 'Penny,' a chatbot designed to help cancer survivors reengage with healthcare by aiding in scheduling appointments and necessary medical procedures. It will be compared against the standard follow-up care practices.

Participant Groups

Group I: Penny text-messaging program Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

Findings from Research

A multi-site, randomized controlled trial is investigating the effectiveness of a Smartphone application called My Guide, designed to improve health-related quality of life (HRQoL) and reduce cancer-specific distress among Hispanic breast cancer survivors over a six-week period.

The study will assess the impact of the intervention compared to a health education control app, with outcomes measured at three different time points, highlighting the potential of eHealth solutions to enhance supportive care accessibility for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors. Yanez, BR., Buitrago, D., Buscemi, J., et al.[2021]

The interactive electronic Cancer Survivorship Patient Engagement Toolkit (CaS-PET) significantly improved health-related quality of life and reduced symptom burden among 30 cancer survivors over a three-month period.

The toolkit effectively supports cancer survivors transitioning from treatment to survivorship by providing personalized care plans and ongoing communication, highlighting its potential as a valuable resource in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Impact of a Cancer Survivorship Patient Engagement Toolkit on Selected Health Outcomes. Nahm, ES., Miller, K., McQuaige, M., et al.[2020]

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 randomized controlled trial involving 300 women with early-stage, hormone receptor-positive breast cancer is testing a web-enabled app designed to improve adherence to adjuvant endocrine therapy (AET) by managing symptoms and providing feedback.

The study aims to assess the app's impact on medication adherence, symptom burden, and quality of life over six months, with a focus on addressing racial disparities in breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. Paladino, AJ., Anderson, JN., Krukowski, RA., et al.[2022]

Thirty cancer survivors, primarily female and averaging 60 years old, expressed feeling unprepared for post-treatment care and highlighted unmet needs in follow-up support, indicating a gap in communication with care providers.

Participants were generally positive about an eHealth application that could monitor symptoms, provide information between appointments, and offer personalized advice, suggesting it could enhance access to supportive care for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving access to supportive cancer care through an eHealth application: a qualitative needs assessment among cancer survivors. Lubberding, S., van Uden-Kraan, CF., Te Velde, EA., et al.[2022]

A study involving 14 clinicians revealed that motivations for reporting serious oncology-associated adverse drug reactions included scientific curiosity and public health concerns, but feedback from pharmaceutical manufacturers was predominantly negative.

The research highlights the need for improved pharmacovigilance mechanisms, such as big data and registries, to enhance the reporting and documentation of adverse drug events, addressing barriers like complacency and indifference among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. Bennett, CL., Schooley, B., Taylor, MA., et al.[2020]

In a study of 139 breast cancer patients undergoing chemotherapy, using a mobile app for symptom tracking improved the stabilization of daily functional activity when patients reviewed their data with a physician, compared to those who used the app unsupervised.

Patients using the app reported more adverse events than those using traditional questionnaires, indicating that the app enhances awareness and reporting of chemotherapy side effects, particularly when used in a supervised setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. Egbring, M., Far, E., Roos, M., et al.[2022]

An automated chatbot (Chats) was found to be a feasible tool for supporting head and neck cancer patients during radiation treatment, with 89% of users finding it easy to use and 61% reporting it helped with symptom self-management.

The study revealed a fair concordance between patient-reported outcomes and clinician-reported outcomes, highlighting that patients often under-reported symptoms like salivary duct inflammation and xerostomia, indicating the chatbot could help bridge this gap in communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated health chats for symptom management of head and neck cancer patients undergoing radiation therapy. Ma, D., Orner, D., Ghaly, MM., et al.[2022]

The BPSS app, designed to support breast cancer patients during chemotherapy, did not show significant improvements in anxiety, depression, or health literacy compared to patients who did not use the app, based on a study of 102 patients.

Despite the lack of improvement in psychological outcomes, the app effectively recorded a high number of side effects, revealing that medical staff often underestimated the severity of patients' symptoms, suggesting the app could enhance communication and care between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. Handa, S., Okuyama, H., Yamamoto, H., et al.[2021]

The Breast Cancer e-Support mobile app is designed to improve self-efficacy, social support, and symptom management for women undergoing chemotherapy, with a study involving 108 participants to assess its effectiveness over 6 months.

This study is the first in China to rigorously evaluate a mobile app intervention for breast cancer patients, aiming to enhance their quality of life and psychological well-being through tailored support and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. Zhu, J., Ebert, L., Liu, X., et al.[2022]

The BREATH trial, involving 150 early breast cancer survivors, demonstrated that a web-based self-management intervention significantly reduced distress levels compared to standard care alone, with a small-to-medium effect size.

While the intervention improved distress, it did not have a lasting impact on empowerment, indicating that while immediate psychological support is beneficial, further strategies may be needed for sustained empowerment in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial. van den Berg, SW., Gielissen, MF., Custers, JA., et al.[2022]

64% of cancer survivors reported using electronic communication with their clinicians, with a slight increase during the COVID-19 pandemic, indicating a growing trend in digital health communication.

Factors influencing e-communication use included being younger, white, living in urban areas, having a breast cancer diagnosis, previously seeking cancer information, and having a regular healthcare provider, highlighting disparities that need to be addressed for equitable cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Electronic Communication with Clinicians Among Cancer Survivors: Health Information National Trend Survey in 2019 and 2020. Cho, Y., Yang, R., Gong, Y., et al.[2023]

The app developed by Breast Cancer Care is designed to support individuals with breast cancer in adjusting to life after their hospital treatment has concluded.

This initiative highlights the importance of ongoing support and resources for breast cancer survivors to help them navigate their recovery and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BECCA. [2019]

Out of 776 health apps identified for supporting breast cancer treatment and aftercare, only 12 were classified as partially recommended and just 3 as recommended, indicating that most apps do not meet quality standards for patient support.

The evaluation criteria included user assessments and scientific benefits, highlighting that while some apps may offer potential benefits for breast cancer patients, the majority lack sufficient quality and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. Gomm, SIM., Ebner, FK., Lukac, S., et al.[2023]

References

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

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors. [2021]

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

Testing the Impact of a Cancer Survivorship Patient Engagement Toolkit on Selected Health Outcomes. [2020]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improving access to supportive cancer care through an eHealth application: a qualitative needs assessment among cancer survivors. [2022]

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

Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Automated health chats for symptom management of head and neck cancer patients undergoing radiation therapy. [2022]

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

Effectiveness of a Smartphone Application as a Support Tool for Patients Undergoing Breast Cancer Chemotherapy: A Randomized Controlled Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A mobile application of breast cancer e-support program versus routine Care in the treatment of Chinese women with breast cancer undergoing chemotherapy: study protocol for a randomized controlled trial. [2022]

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

BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer--Results of a Multicenter Randomized Controlled Trial. [2022]

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

Use of Electronic Communication with Clinicians Among Cancer Survivors: Health Information National Trend Survey in 2019 and 2020. [2023]

13. England pubmed.ncbi.nlm.nih.gov

BECCA. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Mobile Applications Available in Germany Supporting Breast Cancer Patients During Treatment and Aftercare: a Systematic Review. [2023]