Last updated: 06/12/2019 08:30:22
Perceptions of cell and gene therapies (CGT) for the treatment of cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Understanding Patients and Prescriber Perceptions of Cell and Gene Therapy (CGT) in Oncology
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with feedback as having benefit of CGT during interview
Timeframe: Up to 90 minutes
Number of subjects with feedback as having concerns of CGT during interview
Timeframe: Up to 90 minutes
Number of subjects with feedback as having fear of CGT during interview
Timeframe: Up to 90 minutes
Number of subjects with willingness to be treated with CGTs
Timeframe: Up to 90 minutes
Number of physicians who would initiate potential referrals to utilize CGT therapies
Timeframe: Up to 60 minutes
Number of physicians with decisions to use CGT in subjects with cancer
Timeframe: Up to 60 minutes
Number of physicians with concerns to use CGT in subjects with cancer
Timeframe: Up to 60 minutes
Number of physicians with feedback as CGT sound better than other types of cancer treatments
Timeframe: Up to 60 minutes
Number of physicians with feedback as CGT sound more concerning than other types of cancer treatments
Timeframe: Up to 60 minutes
Number of physicians with feedback of recommending CGT in the future
Timeframe: Up to 60 minutes
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
Not applicable
Primary completion date:
2018-12-06
Observational study model:
Cohort
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
- For cancer subjects:
- Adults 18 years of age and older of any, sex, racial/ethnic group, or economic status
- For cancer subjects:
- Diagnosed with cancer less than a year ago or those on first line of treatment at the time of the interview
Inclusion and exclusion criteria
Inclusion criteria:
- 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:
- 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
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Collegeville, Pennsylvania, United States, 19426
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-12-06
Actual study completion date
2018-12-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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