NCT04483349

Brief Summary

To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life \[QOL\], cost, experience), and how these patients’ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

July 14, 2020

Last Update Submit

August 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)

    We will calculate the mean rank of patients yielding usable data and its corresponding 95% confidence interval. Patient characteristics and survey items will be summarized using descriptive statistics, including means, standard deviations (SDs), proportions, range, and 95% confidence intervals (CIs), etc.

    Survey completion up to 1 year

Secondary Outcomes (2)

  • Most important attributes of value to healthcare providers

    Survey completion up to 1 year

  • Importance care providers (i.e., physicians, nurses, administrators) place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)

    Survey completion up to 1 year

Study Arms (1)

Observational (survey administration)

Patients and healthcare providers complete a survey over 10-15 minutes.

Other: Survey Administration

Interventions

Complete survey

Observational (survey administration)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma, and healthcare providers involved in the care of gastric and pancreatic cancer patients at the MD Anderson Cancer Center

You may qualify if:

  • Any patient who has been treated, or is anticipated to be treated, for potentially resectable, biopsy-proven pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma
  • Providers involved in the care of gastric and pancreatic cancer patients. Providers will include non-collaborative surgical oncologists, medical oncologists, radiation oncologists, administrators, nurses, mid-level providers
  • Able to understand the description of the study and willing to participate

You may not qualify if:

  • Inability to read and answer questions in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Somatostatinoma

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, Islet CellPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Matthew H Katz

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 23, 2020

Study Start

June 11, 2020

Primary Completion

August 11, 2022

Study Completion

August 11, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations