Last updated: 06/12/2019 08:30:22

Perceptions of cell and gene therapies (CGT) for the treatment of cancer

GSK study ID
207202
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Other: Telephonic interview
  • Enrollment:
    Not applicable
    Primary completion date:
    2018-12-06
    Observational study model:
    Cohort
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms
    Product
    GSK3377794
    Collaborators
    Not applicable
    Study date(s)
    December 2017 to June 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    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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