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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04427761
Other study ID # 20-038
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 5, 2020
Est. completion date June 2024

Study information

Verified date February 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 55
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Hunter College School of Nursing

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Extent of the change experienced by patients with pancreatic cancer 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
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