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 2019-02-05.
Sponsored by GlaxoSmithKline · Observational
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.
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.
For cancer subjects:
For Oncologists:
Exclusion Criteria:
For cancer subjects:
For Oncologists:
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.
Other: Telephonic interview
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.
Other: Telephonic interview
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.
Other: Telephonic interview
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.
Other: Telephonic interview
Subjects with cancer and Oncologists will undergo a semi-structured one-to-one telephonic interview for up to 90 and 60 minutes respectively.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 60 minutes
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline