Status:
COMPLETED
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Health Research Associates, Inc.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to conduct in-person qualitative interviews of subjects who have different tumor types to identify and assess relevant PROMIS physical function items that can be utilize...
Eligibility Criteria
Inclusion
- Subject has a confirmed diagnosis of a primary tumor of one of the following: Breast Cancer, Prostate Cancer, NSCLC, Multiple Myeloma (excluding smoldering/asymptomatic multiple myeloma) and DLBCL or Follicular Lymphoma
- Subject is able to read, write, and speak English well enough to understand and complete Informed Consent Form (ICF) and take part in the interview process
- Subject has received treatment for their qualifying tumor within the prior 6 months, with the exception of treatment-naïve subjects who have been diagnosed within the past 6 months
- Subject is at least 18 years of age
- Subject has an estimated life expectancy of 3 months or greater
Exclusion
- Subject has more than one current primary tumor
- Subject has a Stage 0 or in situ neoplasm
- Subject has known unstable and/or untreated brain metastasis
- Subject had major surgery within the last 30 days prior to enrolment that may be associated with changes in physical function. Open biopsy is considered a major surgery
- Subject has a current or past history of a personality disorder, bipolar disorder, schizophrenia or other psychotic disorder, obsessive compulsive disorder, cognitive disorder, post-traumatic stress disorder, or other mental deficit
- In the opinion of the site investigator or study director, subject has any medical condition or disorder that could compromise his/her ability to give written informed consent and/or prevent or interfere with the Subject's ability to successfully participate in a face-to-face interview and provide meaningful and non-confounded information about their experience with their qualifying tumor
Key Trial Info
Start Date :
December 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03351140
Start Date
December 20 2017
End Date
May 8 2020
Last Update
July 14 2021
Active Locations (1)
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1
GSK Investigational Site
Mountlake Terrace, Washington, United States, 98034