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

• ClinicalTrials.gov Identifier: NCT03351140
• Recruitment Status: Completed
• First Posted: November 22, 2017
• Last Update Posted: July 14, 2021
• Sponsor: GlaxoSmithKline
• Collaborator: Health Research Associates, Inc.
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment
Neoplasms	Other: Qualitative Interviews; Other: PROMIS Physical Function Items

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology Clinical Trials
• Actual Study Start Date: December 20, 2017
• Actual Primary Completion Date: May 8, 2020
• Actual Study Completion Date: May 8, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Subjects with breast cancer; Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study	Other: Qualitative Interviews; 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.; Other: 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	Other: Qualitative Interviews; 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.; Other: 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	Other: Qualitative Interviews; 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.; Other: 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	Other: Qualitative Interviews; 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.; Other: 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	Other: Qualitative Interviews; 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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Washington

GSK Investigational Site

Mountlake Terrace, Washington, United States, 98034

Sponsors and Collaborators

GlaxoSmithKline

Health Research Associates, Inc.

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03351140
• Other Study ID Numbers: 207113
• First Posted: November 22, 2017
• Last Update Posted: July 14, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:

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