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
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|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||Behavioral: Measurement of Transitions in Cancer Scale (MOT-CA) Survey Behavioral: Distress Thermometer Survey|
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|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|
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).
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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).
- previous history of cancer within the past five years, except for non-melanoma skin cancer, ductal carcinoma in situ breast cancer, and thyroid cancer.
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
|United States, New York|
|Memorial Sloan Kettering Cancer Center (All Protocol Activities)|
|New York, New York, United States, 10065|
|Principal Investigator:||Jessica Goldberg, RN, MSN, AGPCNP-BC, ACHPN||Memorial Sloan Kettering Cancer Center|
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|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: email@example.com.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Quality of Life
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases