NeoplasmsNCT03336567
Perceptions of Cell and Gene Therapies (CGT) for the Treatment of Cancer
An observational study of Neoplasms, run by GlaxoSmithKline at 1 site in United States.
Trial summary
Gene and cell therapies have a real value potential (example: potential long-term effect, curative potential, and single administration) but also drawbacks (example: treatment perceived as complex and risky generating fear and anxiety in subjects and their family; high cost) that require significant educational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Telephonic interview
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 12 Jun 2018
- 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: A small but diverse convenience sample of up to 20 adult cancer subjects and 20 oncologists/hematologist-oncologists in the United States will be included in the study.
Who may be able to join
- For cancer subjects:
- Adults 18 years of age and older of any, sex, racial/ethnic group, or economic status
- With a self-reported diagnosis of non-small-cell lung carcinoma (NSCLC), soft tissue sarcomas, or hematological malignancies
- Willing and able to participate in a telephone interview
- Willing to be audio-recorded during the interview session
- For Oncologists:
Show all 11Show fewer
- Education credentials equivalent to Doctor of Medicine (MD)
- Oncologist/hematologist-oncologist with at least five years of experience in oncology
- Able to fluently read, speak, and understand English to participate in an interview and/or complete all assessments
- Willing and able to participate in a telephone interview
- Willing to be audio-recorded during the interview session
Who cannot join
- For cancer subjects:
- Diagnosed with cancer less than a year ago or those on first line of treatment at the time of the interview
- Unable to provide information on their line of treatment
- Significant speech impairment, cognitive impairment, hearing difficulty, visual impairment, or severe psychopathology (according to the opinion of the screener)
- Any clinically-relevant medical condition including, but not limited to, severe co-morbid condition, severe mental illness, substance abuse, cognitive, or other impairment (e.g., visual) which, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures.
- For Oncologists:
- Currently unable to practice medicine and/or treat subjects, for reasons including (but not limited to): expired medical license, revoked medical license, or part of the Food and Drug Administration (FDA) debarment list.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Collegeville, Pennsylvania, 19426
About this study
Official title: Understanding Patients and Prescriber Perceptions of Cell and Gene Therapy (CGT) in Oncology
Gene and cell therapies have a real value potential (example: potential long-term effect, curative potential, and single administration) but also drawbacks (example: treatment perceived as complex and risky generating fear and anxiety in subjects and their family; high cost) that require significant educational efforts and planning for optimal market access. It is therefore important to understand subject and physician perceptions of T-Cell Receptor (TCR) therapies. The aim of this study is to collect qualitative data from a small but diverse sample of oncologists and subjects in the United States to gather qualitative evidence for a preliminary understanding about their perceptions of T-cell therapies in the treatment of cancer. This cross-sectional study will involve up to 20 adult subjects with cancer and up to 20 oncologists/hematologist-oncologists in the United States. Eligible subjects will be scheduled for a telephone interview lasting approximately 60-90 minutes. Eligible oncologists will be scheduled for a telephone interview lasting approximately 60 minutes.
Searching social media is another way of understanding the perceptions of prescribers and consumers of CGT, in addition to interviews being conducted under the original protocol. The results of a feasibility assessment suggested that it would be helpful to explore social media to add to the findings from the interviews. This social media study(SMS) is being conducted as a pilot study to hone methods for future explorations of social media. The pilot study will investigate and describe initial themes emerging from existing discussions related to CGT. Findings from this work will help GlaxoSmithKline to plan future work in the social media landscape.
- Conditions
- Neoplasms
- Being tested
- Telephonic interview
- Keywords
- telephonic interview, TCR Therapy, cross-sectional, CGT, qualitative
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic interviewOther
Subjects with cancer and Oncologists will undergo a semi-structured one-to-one telephonic interview for up to 90 and 60 minutes respectively.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hematological malignancies | It will include subjects with Refractory Diffuse Large B-cell Lymphoma and Multiple Myeloma, Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) and/or who participated in a CAR-T clinical trial or autologous treatment. Subjects will undergo a telephonic interview for up to 90 minutes. Receives: Other: Telephonic interview | |
| Subjects with NSCLC or soft-tissue sarcoma | It will Include subjects with NSCLC on second or later-line therapy or soft-tissue sarcoma on second or later line therapy. Subjects will undergo a telephonic interview for up to 90 minutes. Receives: Other: Telephonic interview | |
| Oncologists from academic centers with CGT experience | It will include oncologists using TCR therapies, CAR-T or participating in CAR-T or TCR therapy clinical trials. Oncologists will undergo a telephonic interview for up to 60 minutes. Receives: Other: Telephonic interview | |
| Oncologists from community clinics | It will include oncologists from community clinics who evaluate, prescribe, treat, and actively interact with subjects with NSCLC or soft tissue sarcoma, who have used immuno-oncology (IO) therapies. Oncologists will undergo a telephonic interview for up to 60 minutes. Receives: Other: Telephonic interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with feedback as having benefit of CGT during interview
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 90 minutes
Number of subjects with feedback as having concerns of CGT during interview
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 90 minutes
Number of subjects with feedback as having fear of CGT during interview
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 90 minutes
Number of subjects with willingness to be treated with CGTs
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 90 minutes
Number of physicians who would initiate potential referrals to utilize CGT therapies
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Number of physicians with decisions to use CGT in subjects with cancer
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Number of physicians with concerns to use CGT in subjects with cancer
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Number of physicians with feedback as CGT sound better than other types of cancer treatments
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Number of physicians with feedback as CGT sound more concerning than other types of cancer treatments
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Number of physicians with feedback of recommending CGT in the future
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start4 Dec 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336567
- Sponsor's protocol ID
- 207202
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patients and Prescriber Perceptions of Cell and Gene Therapy (CGT) in Oncology
- ClinicalTrials.gov ID
- NCT03336567
- Acronym / sponsor ID
- 207202
- Conditions
- Neoplasms
- Keywords
- telephonic interview, TCR Therapy, cross-sectional, CGT, qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 8 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.
Gene and cell therapies have a real value potential (example: potential long-term effect, curative potential, and single administration) but also drawbacks (example: treatment perceived as complex and risky generating fear and anxiety in subjects and their family; high cost) that require significant educational efforts and planning for optimal market access. It is therefore important to understand subject and physician perceptions of T-Cell Receptor (TCR) therapies. The aim of this study is to collect qualitative data from a small but diverse sample of oncologists and subjects in the United States to gather qualitative evidence for a preliminary understanding about their perceptions of T-cell therapies in the treatment of cancer. This cross-sectional study will involve up to 20 adult subjects with cancer and up to 20 oncologists/hematologist-oncologists in the United States. Eligible subjects will be scheduled for a telephone interview lasting approximately 60-90 minutes. Eligible oncologists will be scheduled for a telephone interview lasting approximately 60 minutes.
Searching social media is another way of understanding the perceptions of prescribers and consumers of CGT, in addition to interviews being conducted under the original protocol. The results of a feasibility assessment suggested that it would be helpful to explore social media to add to the findings from the interviews. This social media study(SMS) is being conducted as a pilot study to hone methods for future explorations of social media. The pilot study will investigate and describe initial themes emerging from existing discussions related to CGT. Findings from this work will help GlaxoSmithKline to plan future work in the social media landscape.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with hematological malignancies | – | Other: Telephonic interviewIt will include subjects with Refractory Diffuse Large B-cell Lymphoma and Multiple Myeloma, Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) and/or who participated in a CAR-T clinical trial or autologous treatment. Subjects will undergo a telephonic interview for up to 90 minutes. |
| Subjects with NSCLC or soft-tissue sarcoma | – | Other: Telephonic interviewIt will Include subjects with NSCLC on second or later-line therapy or soft-tissue sarcoma on second or later line therapy. Subjects will undergo a telephonic interview for up to 90 minutes. |
| Oncologists from academic centers with CGT experience | – | Other: Telephonic interviewIt will include oncologists using TCR therapies, CAR-T or participating in CAR-T or TCR therapy clinical trials. Oncologists will undergo a telephonic interview for up to 60 minutes. |
| Oncologists from community clinics | – | Other: Telephonic interviewIt will include oncologists from community clinics who evaluate, prescribe, treat, and actively interact with subjects with NSCLC or soft tissue sarcoma, who have used immuno-oncology (IO) therapies. Oncologists will undergo a telephonic interview for up to 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A small but diverse convenience sample of up to 20 adult cancer subjects and 20 oncologists/hematologist-oncologists in the United States will be included in the study.
Key inclusion criteria (11 listed)
- Adults 18 years of age and older of any, sex, racial/ethnic group, or economic status
- With a self-reported diagnosis of non-small-cell lung carcinoma (NSCLC), soft tissue sarcomas, or hematological malignancies
- Willing and able to participate in a telephone interview
- Willing to be audio-recorded during the interview session
- Education credentials equivalent to Doctor of Medicine (MD)
Key exclusion criteria (7 listed)
- Diagnosed with cancer less than a year ago or those on first line of treatment at the time of the interview
- Unable to provide information on their line of treatment
- Significant speech impairment, cognitive impairment, hearing difficulty, visual impairment, or severe psychopathology (according to the opinion of the screener)
- Any clinically-relevant medical condition including, but not limited to, severe co-morbid condition, severe mental illness, substance abuse, cognitive, or other impairment (e.g., visual) which, in the opinion of the investigator, would interfere with participating in an interview and/or completing the study procedures.
- Currently unable to practice medicine and/or treat subjects, for reasons including (but not limited to): expired medical license, revoked medical license, or part of the Food and Drug Administration (FDA) debarment list.
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 |
|---|---|---|
| Telephonic interviewSubjects with cancer and Oncologists will undergo a semi-structured one-to-one telephonic interview for up to 90 and 60 minutes respectively. | Other | Oncologists from academic centers with CGT experience, Oncologists from community clinics, Subjects with NSCLC or soft-tissue sarcoma, Subjects with hematological malignancies |
Primary outcome
Number of subjects with feedback as having benefit of CGT during interview
Time frame: Up to 90 minutes
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of subjects with feedback as having concerns of CGT during interview
Time frame: Up to 90 minutes
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of subjects with feedback as having fear of CGT during interview
Time frame: Up to 90 minutes
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of subjects with willingness to be treated with CGTs
Time frame: Up to 90 minutes
Telephonic interview will be conducted to assess preliminary understanding about subjects perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians who would initiate potential referrals to utilize CGT therapies
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians with decisions to use CGT in subjects with cancer
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians with concerns to use CGT in subjects with cancer
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians with feedback as CGT sound better than other types of cancer treatments
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians with feedback as CGT sound more concerning than other types of cancer treatments
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
Number of physicians with feedback of recommending CGT in the future
Time frame: Up to 60 minutes
Telephonic interview will be conducted to assess preliminary understanding about physicians perceptions of CGT, especially TCR and CAR T-Cell therapies in the treatment of cancer.
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 5 Feb 2019.
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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
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
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 11 inclusion and 7 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 5 Feb 2019. 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?
Number of subjects with feedback as having benefit of CGT during interview (time frame: Up to 90 minutes). The study lists 10 primary outcomes in all. 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 5 Feb 2019.