Small Cell Cervix Survey

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01606293
First received: May 23, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Objectives:

Primary: 1. To assess the feasibility of using social networking groups to survey patients with rare cancers.

Secondary:1. To elucidate the current means for diagnosis and treatment of women with small and large cell carcinomas of the cervix. 2. To evaluate anxiety regarding diagnosis, treatment, and recurrence among women with small and large cell carcinomas of the cervix.


Condition Intervention
Cervical Cancer
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Using Social Networking Groups to Survey Patients with Rare Cancers. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The entire study will be conducted electronically. A survey assessing presentation of disease, treatment history and follow-up will be hosted on a secured online server. In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments.


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carcinomas of the Cervix Survey
Women with small and large cell carcinomas of the cervix, who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link.
Behavioral: Questionnaires
Completion of online surveys taking approximately 15 - 20 minutes.
Other Name: Electronic surveys

Detailed Description:

The entire study will be conducted electronically. A survey assessing presentation of disease, treatment history and follow-up (appendix A) will be hosted on a secured online server. In addition respondents will be asked to complete a battery of 40 questions assessing anxiety regarding their diagnosis and fear of recurrence based on previously published instruments (appendix B).

Patients will be asked to provide data on the presenting symptoms at the time of the diagnosis, method of diagnosis, HPV detection, modalities used as initial treatment, specialty of the physician administering the treatment, stage, follow up interval and diagnostic studies, recurrence free interval and treatments offered/received at the time of recurrence.

To assess anxiety and fear of recurrence we will be using questions from instruments initially used in a breast cancer population:

The Concerns About Recurrence Scale (CARS): The CARS has two main parts. In the first part, overall fear of recurrence is assessed with four questions addressing frequency, potential for upset, consistency, and intensity of fears. Participants rate each of these items on a 1-to-6 scale. In the second part, the nature of women's fears about recurrence is assessed with 26 items that follow the stem phrase: "I worry that a recurrence of cancer would" Participants use a 5-pointscale, ranging from 0 (not at all), to 1 (a little), to 2 (moderately), to 3 (a lot), and to 4 (extremely), to indicate the extent to which they worry about each item.

Lerman Cancer Worry Scale: This includes three items, one measuring the frequency of worrying about "getting recurrence cancer someday," and two items measuring the impact of worry on mood and performing daily activities. For cancer worry, subjects will rate their current levels of worry about getting cancer recurrence someday on a 5-point scale with points labeled not at all (1), rarely (2), sometimes (3), often (4), and almost all the time (5). For impact of worry on mood and on functioning, respondents experiencing cancer worries will rate the current impact of such worries on their moods and on their ability to perform their daily activities using a 4-point scale with points labeled not at all (I),a little (2), somewhat (3), and a lot (4).

The Survey will be offered to all patients who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link. We expect the survey to take participants 15-20 minutes to complete. Surveys with similar anxiety measuring elements conducted by phone and on the internet have been reported with success.

Patients will be presented with an online informed consent prior to taking the survey. In addition patients will be provided with an email address and a phone number to use if they have any questions or wish to withdraw from the study. Upon reading the informed consent patients will be able to proceed to the questionnaire hence signifying their informed consent or back to Facebook indicating their refusal. No personal identifying data will be collected. Prior to taking the survey they will be given a serial number to associate with their answers in case they wish to withdraw in the future.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who are members of the Facebook group found at the uniform resource locator https://www.facebook.com/SmallCellCC through an online link.

Criteria

Inclusion Criteria:

  • Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who give informed consent and are able to complete a 15 min online survey.

Exclusion Criteria:

  • Women with small cell carcinoma of the cervix who are members of a social networking support group on Facebook who cannot respond to an English online survey.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606293

Contacts
Contact: Michael M. Frumovitz, MD, MPH 713-792-9599

Locations
United States, Texas
UT MD Andreson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael M. Frumovitz, MD,MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01606293     History of Changes
Other Study ID Numbers: 2012-0464
Study First Received: May 23, 2012
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Small cell carcinomas of the cervix
Large cell carcinomas of the cervix
Online surveys
Electronic surveys
Questionnaires
Facebook
Social networking support groups

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma, Large Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014