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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427761
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
Hunter College School of Nursing
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Pancreatic Cancer Behavioral: Measurement of Transitions in Cancer Scale (MOT-CA) Survey Behavioral: Distress Thermometer Survey

Study Design
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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-Illness Transition Experiences Among Patients With Pancreatic Cancer
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical oncology clinic
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427761


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Hunter College School of Nursing
Investigators
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Principal Investigator: Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04427761    
Other Study ID Numbers: 20-038
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life
Health-Illness Transition
20-038
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases