Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Lymphoma

Lymphoma, Follicular

Lymphosarcoma

Follicular Lymphoma

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

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

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

Approximately 30 subjects who have confirmed diagnosis of multiple myeloma excluding smoldering/asymptomatic multiple myeloma will be included in the study

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.

Qualitative Interviews

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.

PROMIS Physical Function Items

GSK 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.

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

Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology 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

Evidence to support the content validity for the selected PROMIS Physical functional items will include the number of subject expressions of given concept.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function	NCT03351140	Neoplasms	Qualitative Int... PROMIS Physical...	18 Years -	GlaxoSmithKline
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function	NCT03351140	Neoplasms	Qualitative Int... PROMIS Physical...	18 Years -	GlaxoSmithKline
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function	NCT03351140	Neoplasms	Qualitative Int... PROMIS Physical...	18 Years -	GlaxoSmithKline

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