Mobile Health App for Cancer Advance Care Planning

Recruiting at 6 trial locations

Overseen By Megan J Shen, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-English, Cognitive impairment, Hospice, others

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

Compensation: Varies

Number of Visits: 3

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app called PACT, designed to help people with advanced cancer plan and communicate their care preferences if they become unable to speak for themselves. The app facilitates involving family and friends in these crucial conversations. Participants will either use the PACT app or receive standard care without it. This trial suits those with advanced cancer who have access to a smartphone and wish to involve a loved one in their care planning. As an unphased trial, it offers a unique opportunity to contribute to innovative solutions for patient care communication.

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 a mobile app for planning care, so it's unlikely to require changes to your medication.

What prior data suggests that this mobile health app is safe for advance care planning?

Research has shown that the Planning Advance Care Together (PACT) app aids people with cancer and their loved ones in discussing future care plans. The app is currently being tested for effectiveness, and it poses no safety concerns since it is a mobile app, not a drug or medical procedure.

The trial is labeled as "Not Applicable" in terms of phase, indicating that the app is in the early stages of testing with real users. As a mobile app, it lacks the safety risks associated with new medications or treatments. No reports of issues from using mobile health apps like PACT have been provided, suggesting that the app is likely safe for planning future care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health (mHealth) App for Cancer Advance Care Planning because it offers a novel way to support patients in their care journey. Unlike traditional cancer care, which often relies on in-person consultations and paper-based advance directives, the PACT mHealth app allows patients to engage in advance care planning through their smartphones. This digital approach provides the convenience of accessing information and making care decisions anytime and anywhere. Additionally, the app can facilitate more personalized and continuous communication between patients and healthcare providers, potentially leading to more aligned and timely care decisions.

What evidence suggests that the PACT app is effective for advance care planning in cancer patients?

Research has shown that mobile health apps like PACT, which participants in this trial may use, can help cancer patients and their families communicate and plan more effectively. These apps generally excel at facilitating discussions about care. Studies indicate that apps can assist patients in making important plans by involving their friends and family. This suggests that the PACT app could make planning for future care easier and more accessible. Although specific data on PACT's effectiveness is limited, the success of similar apps is encouraging. ^{1 2 3 6 7}

Who Is on the Research Team?

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced cancers like pancreatic, liver, lung, or gynecological cancer who've had at least one round of chemotherapy. Participants need internet access on a mobile device and an English-speaking loved one to join the study. It's not for those under 18, in hospice care, severely cognitively impaired, non-English speakers, or too ill to do interviews.

Inclusion Criteria

I have a smartphone or tablet with internet for the study.

My caregiver speaks English, is over 18, and can legally agree to help.

My advanced cancer has worsened after the first treatment.

Exclusion Criteria

I am not in hospice care.

I am too sick or weak to complete interviews.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to use the PACT mHealth app or engage in standard care

3 months

Ongoing app usage and standard care visits

Follow-up

Participants are monitored for usability, engagement, and changes in advance care planning

3 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• PACT

Trial Overview The trial is testing the PACT mobile app designed to facilitate advance care planning discussions among cancer patients with their families and doctors. The aim is to integrate social support into making future healthcare decisions if they can't communicate themselves.

How Is the Trial Designed?

Group I: Arm I (PACT) Experimental Treatment 2 Interventions

Participants use PACT mHealth app.

Group II: Arm II (standard care) Active Control 2 Interventions

Participants engage in standard care with no modifications.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The PREPARE web-based resource for advance care planning was found to be acceptable, applicable, and understandable for oncology patients, based on feedback from 21 participants receiving cancer treatment.

Some participants expressed difficulty with the language related to life-limiting conditions, suggesting a need for revisions to ensure it does not cause distress or disengagement from advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an advance care planning web-based resource: applicability for cancer treatment patients. Cresswell, MA., Robinson, CA., Fyles, G., et al.[2022]

In a study of nine adolescent and young adult cancer patients who died after participating in an advance care planning trial, all had a surrogate decision maker and care limitations documented in their electronic health records, highlighting the importance of advance care planning in end-of-life care.

However, the lack of standardized documentation in electronic health records complicated the assessment of treatment preferences and their alignment with end-of-life care, revealing issues like family conflict that advance care planning aims to prevent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. Watson, A., Weaver, M., Jacobs, S., et al.[2020]

In a study of 456 patients with terminal cancer, only 6% had documented care goals in case of acute deterioration, highlighting a significant gap in advance care planning.

A quality improvement initiative was launched to enhance documentation and referral rates to palliative care, aiming to ensure better patient support and care planning in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. Harle, I., Karim, S., Raskin, W., et al.[2022]

In a study of 435 cancer patients across three healthcare systems, unstructured electronic health record data revealed a higher prevalence of advance care planning (ACP) documentation (54.7%) compared to structured data (42.9%).

The study found that a significant portion (16.6%) of patients with structured ACP documentation had records that were misclassified or incomplete, highlighting the need for incorporating unstructured data to get a more accurate picture of ACP activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forms or Free-Text? Measuring Advance Care Planning Activity Using Electronic Health Records. Zupanc, SN., Lakin, JR., Volandes, AE., et al.[2023]

In a study of 433 older adults with cancer, only 43.2% had structured advance care planning (ACP) data recorded in electronic health records (EHRs), highlighting a significant gap in data availability.

Among the structured ACP data, only 59.2% were accurate, with a notable presence of incorrect (23.7%) and duplicate (17.1%) entries, indicating reliability issues that could impact patient care and research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. Lakin, JR., Gundersen, DA., Lindvall, C., et al.[2022]

A study involving 30 palliative cancer patients showed that remote monitoring using wearables is feasible, with 83% of participants completing the 12-week study and positive feedback on usability.

Patients used the smartphone app on 85% of study days and managed the wearable devices well, indicating a good level of acceptance, although the bracelet was worn less frequently at night.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Usability Aspects of Continuous Remote Monitoring of Health Status in Palliative Cancer Patients Using Wearables. Pavic, M., Klaas, V., Theile, G., et al.[2020]

The Accordons-nous app, designed to assist patients with advance care planning, demonstrated high usability, with 80% of tasks completed independently by users during testing, indicating it is user-friendly.

Participants rated the app highly for readability and relevance, scoring 87.4 on the readability test and 4.3 out of 5 on the relevance scale, suggesting it effectively communicates important information about advance directives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Advance Care Planning and Advance Directives (Accordons-nous): Development and Usability Study. Schöpfer, C., Ehrler, F., Berger, A., et al.[2022]

A review of nine advance care planning mobile applications revealed that they generally have limited features and poor design quality, which may hinder their effectiveness in supporting patient-centered care.

Most apps focus on decision-making and sharing advance care planning documents, but only a few provide adequate support for understanding or contemplating advance care planning, indicating a need for improvement in app content and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications for Advance Care Planning: A Comprehensive Review of Features, Quality, Content, and Readability. McDarby, M., Llaneza, D., George, L., et al.[2022]

The Accordons-nous app significantly increased patients' engagement in advance care planning (ACP) compared to a traditional leaflet, with notable improvements in contemplation (+11%) and discussions about ACP (+5%).

Older participants were more likely to write advance directives, indicating that age positively influences ACP engagement, while other socio-demographic factors like gender and education did not show significant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an app for promoting advance care planning and motivating patients to write their advance directives. Schöpfer, C., Bollondi, C., Moussa, MA., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04515810

Mobile Health Application (PACT) to Improve Engagement ... This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2022-00398

Mobile Health Application (PACT) to Improve Engagement ... This clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan ...

3. reporter.nih.gov reporter.nih.gov/search/5WUFLzZ6J0SLMZCryYhsfw/project-details/10914153

Project Details - NIH RePORTER The proposed study will address this public health issue by developing and pilot testing a mobile application (Planning Advance Care Together, PACT) designed to ...

4. withpower.com withpower.com/trial/phase-11-2021-c7c9e

Mobile Health App for Cancer Advance Care Planning What data supports the effectiveness of the treatment PACT in the Mobile Health App for Cancer Advance Care Planning trial? Research suggests that mobile ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11294773/

Acceptability, Effectiveness, and Roles of mHealth ... mHealth apps are effective and acceptable in supporting pain self-management. They offer a promising multi-model approach for patients to monitor, track, and ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04515810?keyword=%22End-of-Life%22

San Mateo Clinical Trial Mobile Health Application (PACT) ... Advance care planning for cancer patients: a systematic review of perceptions and experiences of patients, families, and healthcare providers ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38145252/

Acceptability and usability of the Planning Advance Care ... The current study developed the Planning Advance Care Together (PACT) website to foster inclusion of loved ones in the ACP process. Methods: To ...