An observational study in Neoplasms, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by GlaxoSmithKline · Observational
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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.
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's enrollment of 1 is below the median of 200 across 2,641 observational studies indexed under Neoplasms.
Browse Neoplasms studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study
Other: Qualitative Interviews · Other: PROMIS Physical Function Items
Approximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study
Other: Qualitative Interviews · Other: PROMIS Physical Function Items
Approximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study
Other: Qualitative Interviews · Other: 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
Other: Qualitative Interviews · Other: PROMIS Physical Function Items
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
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.
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
Time frame: Approximately 90 minutes
Number of subject expressions of a given concept
Evidence to support the content validity for the selected PROMIS Physical functional items will include the number of subject expressions of given concept.
Time frame: Approximately 90 minutes
Number of interviews to reach saturation of 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.
Time frame: Approximately 90 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in May 2020, 28 months.
Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's 28 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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