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

NCT03351140 | Completed

• 1 other identifier: 207113
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• Number of subject expressions of a given concept

  Approximately 90 minutes

• Number of interviews to reach saturation of concept

  Approximately 90 minutes

Study Arms (5)

Subjects with breast cancer

Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study

Other: Qualitative Interviews; Other: PROMIS Physical Function Items

Subjects with prostate cancer

Approximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study

Other: Qualitative Interviews; Other: PROMIS Physical Function Items

Subjects with NSCLC

Approximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study

Other: Qualitative Interviews; Other: PROMIS Physical Function Items

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; Other: PROMIS Physical Function Items

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; Other: PROMIS Physical Function Items

Interventions

Qualitative Interviews OTHER

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.

Subjects with DLBCL or follicular lymphoma; Subjects with NSCLC; Subjects with breast cancer; Subjects with multiple myeloma; Subjects with prostate cancer

PROMIS Physical Function Items OTHER

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; Subjects with NSCLC; Subjects with breast cancer; Subjects with multiple myeloma; Subjects with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Health Research Associates, Inc.: collaborator

Study Sites (1)

GSK Investigational Site

Mountlake Terrace, Washington, 98034, United States

Location

MeSH Terms

Conditions

Neoplasms; Multiple Myeloma; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Lymphoma, Follicular; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 22, 2017
• Study Start: December 20, 2017
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)