Perceptions of Cell and Gene Therapies (CGT) for the Treatment of Cancer

February 2, 2019 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Collegeville, Pennsylvania, United States, 19426
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 90 minutes
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.
Up to 90 minutes
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.
Up to 90 minutes
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.
Up to 90 minutes
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.
Up to 60 minutes
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.
Up to 60 minutes
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.
Up to 60 minutes
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.
Up to 60 minutes
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.
Up to 60 minutes
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.
Up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 207202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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