Clinical trial NCT03351140: Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function
Official title: Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Multiple Myeloma
Patient-Reported Outcome Measurement Information System (PROMIS)
Non-Small Cell Lung Cancer (NSCLC)
Breast cancer
Diffuse Large B-Cell (DLBCL)
Follicular Lymphoma
Prostate Cancer
Qualitative interview
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Health Research Associates, Inc.
First posted: 2017-11-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with confirmed diagnosis of breast cancer or prostate cancer or NSCLC or multiple myeloma, DLBCL or Follicular Lymphoma will be included in this study.

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 utilized in future studies. Health Research Associates (HRA) will conduct qualitative interviews in subjects with a variety of cancer types. PROMIS is a set of self-report measurement tools, developed by the United States (US) National Institutes for Health (NIH). The most recent version of PROMIS Physical Function Item Bank contains 165 items assessing a range of abilities and its subset, a 45-item PROMIS Function Cancer Item Bank which contains questions relevant to subjects with cancer. Approximately 150 subjects with five tumor types will be recruited. HRA will conduct the interviews that will be audio-recorded for transcription and analysis. Five tumor types that will be focused on are Breast, Prostate, Non-Small-Cell Lung Cancer (NSCLC), Multiple Myeloma, and Diffuse Large B-Cell (DLBCL) or Follicular Lymphoma. Interviews will be conducted in English language in private areas within clinic site or rented meeting facilities and will last approximately for 60-90 minutes.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Conduct qualitative patient interviews with a range of cancer patients across multiple tumor types to identify a subset of relevant PROMIS Physical Function items that can be utilized in future clinical trials
timeFrame: Approximately 90 minutes
Secondary outcomes:
measure: Number of subject expressions of a given concept
timeFrame: Approximately 90 minutes
measure: Number of interviews to reach saturation of concept
timeFrame: Approximately 90 minutes
Other outcomes:
Locations:
city: Mountlake Terrace
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: