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Trial Title:
Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix
NCT ID:
NCT01606293
Condition:
Cervical Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Large Cell
Conditions: Keywords:
Small cell carcinomas of the cervix
Large cell carcinomas of the cervix
Online surveys
Electronic surveys
Questionnaires
Facebook
Social networking support groups
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Questionnaires
Description:
Completion of online surveys taking approximately 15 - 20 minutes.
Arm group label:
Carcinomas of the Cervix Survey
Other name:
Electronic surveys
Summary:
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.
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.
Criteria for eligibility:
Study pop:
All patients who are members of the Facebook group found at the uniform resource locator
https://www.facebook.com/SmallCellCC through an online link.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
May 24, 2012
Completion date:
May 2021
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01606293
http://www.mdanderson.org