Patient‐Reported Outcome Measurement Information System (PROMIS) Physical Function
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | December 20, 2017 |
| End Date: | June 28, 2019 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology Clinical Trials
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.
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.
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
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