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 clinical trial tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.

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.

How does the PACT treatment differ from other treatments for cancer advance care planning?

The PACT treatment is unique because it uses a mobile health app to facilitate advance care planning, helping patients express their care preferences and communicate them effectively. Unlike traditional methods, this app-based approach emphasizes patient autonomy and ease of use, making it more accessible and engaging for patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PACT in the Mobile Health App for Cancer Advance Care Planning trial?

Research suggests that mobile apps can help with advance care planning by allowing patients to document their care preferences and share them with others, which may support patient-centered care and autonomy. However, existing apps often have limitations in features and design quality, indicating room for improvement in their effectiveness. ^{5 6 7 8 9}

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

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]

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]

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]

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]

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]

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]

Citations

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

Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Toward improved goals-of-care documentation in advanced cancer: report on the development of a quality improvement initiative. [2022]

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

Mobile Applications for Advance Care Planning: A Comprehensive Review of Features, Quality, Content, and Readability. [2022]

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

Forms or Free-Text? Measuring Advance Care Planning Activity Using Electronic Health Records. [2023]

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

A Yet Unrealized Promise: Structured Advance Care Planning Elements in the Electronic Health Record. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effect of an app for promoting advance care planning and motivating patients to write their advance directives. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an advance care planning web-based resource: applicability for cancer treatment patients. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Usability Aspects of Continuous Remote Monitoring of Health Status in Palliative Cancer Patients Using Wearables. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App for Advance Care Planning and Advance Directives (Accordons-nous): Development and Usability Study. [2022]