CLINICAL TRIAL

PACT for Metastatic Lung Carcinoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Manhasset, NY

This study is evaluating whether a mobile application may help people prepare for end of life care.

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About the trial for Metastatic Lung Carcinoma

Eligible Conditions
Metastatic Lung Carcinoma · Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Stage IVA Hepatocellular Carcinoma AJCC v8 · Refractory Pancreatobiliary Carcinoma · Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Stage III Hepatocellular Carcinoma AJCC v8 · Stage III Lung Cancer AJCC v8 · Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Esophageal Neoplasms · Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Locally Advanced Hepatocellular Carcinoma · Lung Neoplasms · Neoplasms · Locally Advanced Malignant Female Reproductive System Neoplasm · Genital Neoplasms, Female · Stage IIIB Lung Cancer AJCC v8 · Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Adenocarcinoma · Carcinoma · Locally Advanced Lung Carcinoma · Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Stage IV Lung Cancer AJCC v8 · Stage IV Hepatocellular Carcinoma AJCC v8 · Stage IVA Lung Cancer AJCC v8 · Stage IIIA Lung Cancer AJCC v8 · Locally Advanced Pancreatobiliary Carcinoma · Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Refractory Hepatocellular Carcinoma · Refractory Lung Carcinoma · Refractory Malignant Female Reproductive System Neoplasm · Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 · Locally Advanced Gastroesophageal Junction Adenocarcinoma · Metastatic Malignant Female Reproductive System Neoplasm · Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Stage IIIA Hepatocellular Carcinoma AJCC v8 · Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 · Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 · Malignant Solid Neoplasms · Refractory Gastroesophageal Junction Adenocarcinoma · Stage IVB Lung Cancer AJCC v8 · Stage IVB Hepatocellular Carcinoma AJCC v8 · Stage IIIB Hepatocellular Carcinoma AJCC v8 · Carcinoma, Hepatocellular · Stage IIIC Lung Cancer AJCC v8 · Metastatic Gastroesophageal Junction Adenocarcinoma · Metastatic Hepatocellular Carcinoma · Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 · Metastatic Pancreatobiliary Carcinoma · Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 · To Evaluate PACT, a Mobile Application for Improving Engagement in Advance Care Planning

Treatment Groups

This trial involves 3 different treatments. PACT is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Internet-Based Intervention
OTHER
+
Questionnaire Administration
OTHER
Experimental Group 2
PACT
BEHAVIORAL
Control Group 3
Questionnaire Administration
OTHER
+
Best Practice
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PACT
2013
N/A
~960

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PATIENT: The ability to provide informed consent.
CAREGIVER: English speaking.
You have a caregiver who is 18 years of age or older. show original
CAREGIVER: Able to provide informed consent.
You are a health care provider. show original
PROVIDER: A history of 3+ years working with advanced cancer patients.
Patient identifies a loved one/informal caregiver. show original
You have a diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g. show original
Patient must have access to a mobile device with internet access. show original
The person who is the caregiver for the patient. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 3 months post-intervention, and 6 months post-intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 3 months post-intervention, and 6 months post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 3 months post-intervention, and 6 months post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether PACT will improve 6 primary outcomes and 5 secondary outcomes in patients with Metastatic Lung Carcinoma. Measurement will happen over the course of Baseline, 3 months post-intervention, and 6 months post-intervention.

Change in level of engagement in advance care planning (caregiver)
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Change in level of engagement in advance care planning (patient)
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Change in completion of advance directives
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order(DNR), living will, or identified a Health Care Provider(HCP). All yes/no questions.
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Change in documentation of advance care planning conversations
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (or patient) and doctor (or patient's doctor) (all yes/no questions).
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Change in healthcare utilization (summary score for total healthcare utilized)
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
Change in treatment preference
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
BASELINE, 3 MONTHS POST-INTERVENTION, AND 6 MONTHS POST-INTERVENTION
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes to evaluate pact, a mobile application for improving engagement in advance care planning?

There are multiple factors at play in relation to the evaluation of a mobile technology product such as pact. These include design features, user factors, and technology characteristics. These factors are intertwined in a complex way. In this paper, multiple levels of design features and user factors that affect the impact pact had on users and the technology characteristics of pact that influence whether one would use the app to support advance care planning was explored.

Anonymous Patient Answer

What is to evaluate pact, a mobile application for improving engagement in advance care planning?

A web-based patient engagement program significantly increases participation of patients in AODP compared to wait-list control. The program can be further developed for use by healthcare providers to improve patients' engagement in AODP and improve patient outcomes in health care.

Anonymous Patient Answer

What are the signs of to evaluate pact, a mobile application for improving engagement in advance care planning?

Inclusion of EHR features into pact may increase engagement in advance care planning. However, future research is needed to assess the impact of this feature of pact on patient engagement.

Anonymous Patient Answer

What are common treatments for to evaluate pact, a mobile application for improving engagement in advance care planning?

To evaluate pact, we provide a novel platform to assess patient engagement. This approach may help to advance the field of mobile health and telehealth by allowing health consumers to engage in clinical care or personal health care by exchanging information and engaging in other digital activities in the clinic context.

Anonymous Patient Answer

How many people get to evaluate pact, a mobile application for improving engagement in advance care planning a year in the United States?

Nearly 12% of people in the United States who are eligible for EMR do not get to evaluate their pact after their provider makes a recommendation to them.

Anonymous Patient Answer

Can to evaluate pact, a mobile application for improving engagement in advance care planning be cured?

In a recent study, findings did not find a cost-effective mobile application that can be used to encourage patients to engage in advance care planning or to assess their advance care plan.

Anonymous Patient Answer

Who should consider clinical trials for to evaluate pact, a mobile application for improving engagement in advance care planning?

A large part of the US general primary care population could be contacted to participate in a clinical trial for a new device to aid with planning care. Physicians had relatively good recommendations of patients to participate in clinical trials but less positive comments about a new device.

Anonymous Patient Answer

Have there been other clinical trials involving pact?

There has been one trial-based study of pact for patients with advanced dementia, which was based on a small sample. There is a need for further studies about pact and other methods of improving engagement for patients wishing to consider end-of-life care.

Anonymous Patient Answer

Does pact improve quality of life for those with to evaluate pact, a mobile application for improving engagement in advance care planning?

pact may be more effective for communicating and informing about advance care planning options and more effective than discussing personal preferences for end-of-life care, supporting the hypothesis that the use of pact could improve end-of-life care discussion with individuals with advance care planning.

Anonymous Patient Answer

How serious can to evaluate pact, a mobile application for improving engagement in advance care planning be?

The Pact system is a valid and reliable service which can be used to collect and analyse medical-practice related patient data. PACT was the primary contributor to the engagement process, but we argue that further improvements in the system might be attained, mainly through improvements in its support portal.

Anonymous Patient Answer

What is the average age someone gets to evaluate pact, a mobile application for improving engagement in advance care planning?

Most people in both age groups evaluated pact, but people who are over 75 had a stronger engagement in advance care planning, suggesting that they could be more confident in their decision making ability after the evaluation of Pact.

Anonymous Patient Answer

What are the latest developments in pact for therapeutic use?

Mobile pact can help advance advance care planning by engaging and encouraging patients to communicate their views at intervals after receiving the app. For each question answered, people accumulating more points is associated with more engagement, which is then linked to better patient satisfaction. This will help physicians create an interactive platform for patients and their families to discuss plan choices and treatment decisions with patients when appropriate.

Anonymous Patient Answer
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