A Study of the Life Changes Experienced by Patients With Pancreatic Cancer

February 2, 2024 updated by: Memorial Sloan Kettering Cancer Center

Health-Illness Transition Experiences Among Patients With Pancreatic Cancer

The purpose of this study is to better understand what types of transitions people with pancreatic cancer face when they receive chemotherapy. Again, this study defines transition as a change in a life situation or a status that causes a change in a person's identity, role, behavior, or personal relationships. Examples of transitions include changes in sleeping habits, anxiety, employment, relationship with a higher power, and treatment goals.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Medical oncology clinic

Description

Inclusion Criteria:

  • adult patients 18 years of age and older
  • primary language listed as English in electronic medical record
  • biopsy proven diagnosis of pancreatic cancer
  • within three months after initiating a chemotherapy regimen at the Rockefeller Outpatient Pavilion at MSKCC (patient may have previously received chemotherapy at an outside institution or may have received previous chemotherapy regimens at MSKCC).

Exclusion Criteria:

  • previous history of cancer within the past five years, except for non-melanoma skin cancer, ductal carcinoma in situ breast cancer, and thyroid cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pancreatic cancer health-illness transition
In this prospective longitudinal correlational study, a convenience sample of patients with pancreatic cancer receiving chemotherapy will be asked to report on their health-illness transition experiences and their level of distress.
Behavioral: Measurement of Transitions in Cancer Scale (MOT-CA) Survey
These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit) The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).
Behavioral: Distress Thermometer Survey
These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit).The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of the change experienced by patients with pancreatic cancer
Time Frame: 4 to 6 weeks after baseline
Descriptive statistics will be calculated at both time points using (part A on the MOT-CA) for each of the seven transition domains (physical, emotional, social, spiritual, cancer status, treatment, and approach) at both time points (Time 0 and Time 1).
4 to 6 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Hunter College School of Nursing

Investigators

  • Principal Investigator: Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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