Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer

NCT04400903 | Terminated

• 3 other identifiers: STUDY00021185NCI-2020-03178R01CA264133
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

This study examines heart rate monitoring variability for the early detection of pancreatic cancer. Pancreatic cancer is a very difficult disease to detect early. This study is being done to observe the heart rate variability in patients with pancreatic cancer compared to undiagnosed individuals with increased risk of developing pancreatic cancer. This may help researchers determine if pancreatic occurrences/recurrences (chance of coming back) can be detected sooner through monitoring heart rate and activity.

Conditions

Pancreatic Ductal Adenocarcinoma; Stage I Pancreatic Cancer AJCC v8; Stage IA Pancreatic Cancer AJCC v8; Stage IB Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Magnitude of heart rate variability (HRV) decline (Stage I)

  As measured by root mean square of the successive differences (RMSSD) in pancreatic ductal adenocarcinoma (PDAC) patients and in high-risk participants.

  Up to 1 year after enrollment

• Compliance statistics for wristband use (Stage II)

  Defined as the percentage of days during which data were collected during at least 70% of the hours.

  Until onset of PDAC, study withdrawal, or death, whichever occurs first, assessed up to 5 years after enrollment

Secondary Outcomes (5)

• Compliance statistics for wristband use for all participants (Stage I, II)

  Up to 6 weeks and 6 months after enrollment and device activation

• Effectiveness of virtual training (Stage I, II)

  Up to 1 week after enrollment and device activation

• Magnitude of HRV change (Stage II)

  Up to 5 years post enrollment

• Incidence of PDAC among high-risk participants (Stage II)

  Up to 5 years post enrollment

• Time of PDAC diagnosis among high-risk participants who developed PDAC (Stage II)

  Up to 5 years post enrollment

Study Arms (1)

Observational (HRV monitoring, questionnaire)

Participants undergo HRV monitoring using an activity monitor (WHOOP) for a minimum of 5 days weekly for up to 1 year in patients with newly-diagnosed PDAC and up to 5 years for patients in high risk group.

Device: Activity Monitor; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Activity Monitor DEVICE

Undergo HRV monitoring via WHOOP device

Also known as: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device

Observational (HRV monitoring, questionnaire)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (HRV monitoring, questionnaire)

Questionnaire Administration OTHER

Complete questionnaires

Observational (HRV monitoring, questionnaire)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PDAC and participants at high risk for PDAC at Oregon Health and Science University, New York University and University of Nebraska Medical Center

You may qualify if:

• Ability to understand and the willingness to sign an informed consent document
• Own a smartphone that uses Android or Apple iOS operating systems
• Participant must have one of the following:
• Individuals with newly-diagnosed, treatment naive PDAC - all stages (applicable to Stage 1 only), or
• Individuals with at least one of the following family phenotype and age will be included:
• Two or more relatives with PDAC on the same side of the family, where 2 PDAC affected individuals are first-degree related (FDR) AND at least one PDAC-affected individual is an FDR of the subject; Age \>= 50 years OR 10 years before onset in family
• Two affected FDR with PDAC; Age \>= 50 years OR 10 years before onset of an FDR
• Any of BRCA1, BRCA2, PALB2, ATM mutations confirmed pathogenic or likely pathogenic; Age \>= 50 years OR 10 years before onset of an FDR or second-degree relative (SDR)
• Familial atypical multiple mole-melanoma (FAMMM) with confirmed pathogenic or likely pathogenic mutation variants in: p16, CDKN2A; Age \>= 50 years
• Known mutation carrier for STK11 (Peutz-Jeghers syndrome); Age \>= 50 years
• Lynch syndrome (hereditary nonpolyposis colorectal cancer \[HNPCC\]) with confirmed pathogenic or likely pathogenic variants in: MLH1, MSH2, MSH6, PMS2, or EPCAM; Age \>= 50 years OR 10 years before onset of an FDR or SDR
• Hereditary pancreatitis with confirmed PRSS1 pathogenic or likely pathogenic history of pancreatitis; Age \>= 50 years

You may not qualify if:

• Any medical conditions that in the opinion of the investigators would compromise participant safety and/or the integrity of the data

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• American Association for Cancer Research: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Aaron Grossberg

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: September 21, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (3)