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

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: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Other: Telephonic interview

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 60 minutes

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): June 12, 2018

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 5, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cross-sectional; qualitative; CGT; telephonic interview; TCR Therapy
• Other Study ID 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