- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351140
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function
July 13, 2021 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Mountlake Terrace, Washington, United States, 98034
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with breast cancer
Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study
|
Subjects will participate in a qualitative interview lasting up to 90 minutes.
The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL).
In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
PROMIS Physical Function Items is a set of self-report measurement tools.
The latest version of PROMIS Physical Function Items contains 165 items for self-assessment.
PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects.
Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
|
Subjects with prostate cancer
Approximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study
|
Subjects will participate in a qualitative interview lasting up to 90 minutes.
The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL).
In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
PROMIS Physical Function Items is a set of self-report measurement tools.
The latest version of PROMIS Physical Function Items contains 165 items for self-assessment.
PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects.
Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
|
Subjects with NSCLC
Approximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study
|
Subjects will participate in a qualitative interview lasting up to 90 minutes.
The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL).
In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
PROMIS Physical Function Items is a set of self-report measurement tools.
The latest version of PROMIS Physical Function Items contains 165 items for self-assessment.
PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects.
Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
|
Subjects with multiple myeloma
Approximately 30 subjects who have confirmed diagnosis of multiple myeloma excluding smoldering/asymptomatic multiple myeloma will be included in the study
|
Subjects will participate in a qualitative interview lasting up to 90 minutes.
The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL).
In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
PROMIS Physical Function Items is a set of self-report measurement tools.
The latest version of PROMIS Physical Function Items contains 165 items for self-assessment.
PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects.
Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
|
Subjects with DLBCL or follicular lymphoma
Approximately 30 subjects who have confirmed diagnosis of DLBCL or follicular lymphoma will be included in the study
|
Subjects will participate in a qualitative interview lasting up to 90 minutes.
The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL).
In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
PROMIS Physical Function Items is a set of self-report measurement tools.
The latest version of PROMIS Physical Function Items contains 165 items for self-assessment.
PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects.
Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Approximately 90 minutes
|
Number of interviews conducted.
Demographic and clinical characteristics of subjects will include Eastern Cooperative Oncology Group (EGOC) status, current tumor status and latest line of treatment
|
Approximately 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subject expressions of a given concept
Time Frame: Approximately 90 minutes
|
Evidence to support the content validity for the selected PROMIS Physical functional items will include the number of subject expressions of given concept.
|
Approximately 90 minutes
|
Number of interviews to reach saturation of concept
Time Frame: Approximately 90 minutes
|
Evidence to support content validity includes the number of interviews needed to reach saturation of concept, which is the point, after which no new relevant or important information emerges and collecting additional data will not add to the understanding of how patients perceive the concept of interest and the items in a questionnaire.
|
Approximately 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2017
Primary Completion (Actual)
May 8, 2020
Study Completion (Actual)
May 8, 2020
Study Registration Dates
First Submitted
November 9, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
July 14, 2021
Last Update Submitted That Met QC Criteria
July 13, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 207113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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