NeoplasmsNCT03351140
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function
An observational study of Neoplasms, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Qualitative Interviews and PROMIS Physical Function Items
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Mountlake Terrace, Washington, 98034
About this study
Official title: Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology 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.
- Conditions
- Neoplasms
- Being tested
- Qualitative Interviews, PROMIS Physical Function Items
- 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
- Medical subject headings
- Neoplasms, Multiple Myeloma, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Lymphoma, Follicular, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewsOther
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 ItemsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with breast cancer | Approximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Qualitative Interviews; Other: PROMIS Physical Function Items |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 90 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: Approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start20 Dec 2017
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Research Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351140
- Sponsor's protocol ID
- 207113
- Status last verified
- Jul 2021
- First submitted
- 9 Nov 2017
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Interviews to Evaluate the PROMIS Physical Function Item Bank for Use in Oncology Clinical Trials
- ClinicalTrials.gov ID
- NCT03351140
- Acronym / sponsor ID
- 207113
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Health Research Associates, Inc.
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Subjects with breast cancer | – | Other: Qualitative Interviews, Other: PROMIS Physical Function ItemsApproximately 30 subjects who have confirmed diagnosis of breast cancer will be included in the study |
| Subjects with prostate cancer | – | Other: Qualitative Interviews, Other: PROMIS Physical Function ItemsApproximately 30 subjects who have confirmed diagnosis of prostate cancer will be included in the study |
| Subjects with NSCLC | – | Other: Qualitative Interviews, Other: PROMIS Physical Function ItemsApproximately 30 subjects who have confirmed diagnosis of NSCLC will be included in the study |
| Subjects with multiple myeloma | – | Other: Qualitative Interviews, Other: PROMIS Physical Function ItemsApproximately 30 subjects who have confirmed diagnosis of multiple myeloma excluding smoldering/asymptomatic multiple myeloma will be included in the study |
| Subjects with DLBCL or follicular lymphoma | – | Other: Qualitative Interviews, Other: PROMIS Physical Function ItemsApproximately 30 subjects who have confirmed diagnosis of DLBCL or follicular lymphoma will be included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative InterviewsSubjects 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 | Subjects with DLBCL or follicular lymphoma, Subjects with NSCLC, Subjects with breast cancer, Subjects with multiple myeloma, Subjects with prostate cancer |
| PROMIS Physical Function ItemsPROMIS 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. | Other | Subjects with DLBCL or follicular lymphoma, Subjects with NSCLC, Subjects with breast cancer, Subjects with multiple myeloma, Subjects with prostate cancer |
Primary outcome
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
2 secondary outcomes
Number of subject expressions of a given concept
Time frame: Approximately 90 minutes
Number of interviews to reach saturation of concept
Time frame: Approximately 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.