Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function

Completed

• Conditions: Neoplasms
• Interventions: Other: Qualitative Interviews; Other: PROMIS Physical Function Items

• Registration Number: NCT03351140
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-22
• Study Start: 2017-12-20
• Primary Completion: 2020-05-08
• Study Completion: 2020-05-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with DLBCL or follicular lymphoma	Qualitative Interviews	Approximately 30 subjects who have confirmed diagnosis of DLBCL or follicular lymphoma will be included in the study
Subjects with multiple myeloma	Qualitative Interviews	Approximately 30 subjects who have confirmed diagnosis of multiple myeloma excluding smoldering/asymptomatic multiple myeloma will be included in the study
Subjects with breast cancer	Qualitative Interviews	Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study
Subjects with prostate cancer	PROMIS Physical Function Items	Approximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study
Subjects with breast cancer	PROMIS Physical Function Items	Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study
Subjects with NSCLC	Qualitative Interviews	Approximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study
Subjects with NSCLC	PROMIS Physical Function Items	Approximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study
Subjects with multiple myeloma	PROMIS Physical Function Items	Approximately 30 subjects who have confirmed diagnosis of multiple myeloma excluding smoldering/asymptomatic multiple myeloma will be included in the study
Subjects with prostate cancer	Qualitative Interviews	Approximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study
Subjects with DLBCL or follicular lymphoma	PROMIS Physical Function Items	Approximately 30 subjects who have confirmed diagnosis of DLBCL or follicular lymphoma will be included in the study

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
Number of subject expressions of a given concept	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.
Number of interviews to reach saturation of concept	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Mountlake Terrace, Washington, United States