Brief Title
Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
Official Title
Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary
The goal of this psychosocial research study is to examine and explain the influence of
spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer.
Detailed Description
Little is known about the role a patient's spirituality plays in their quality of life. This
study consists of a series of questionnaires that ask questions about religion, spirituality,
and decisions about treatment.
All patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer who
come to the Department of Gynecologic Oncology at M. D. Anderson and affiliated clinics for
care will be offered study participation.
Patients will be asked to complete a series of questionnaires at specific times: at the time
of diagnosis (before their second cycle of therapy begins), at the end of primary
chemotherapy, and one year later. The questionnaires should take a total of about 65 minutes
to complete, and patients can choose not to answer any question they do not want to answer.
Patients who agree to participate but do not have time to fill out the questionnaires during
their visits may return the questionnaire by mail in a pre-stamped envelope.
All participants will be asked to provide the following information: their age, religious
preference, race, marital status, date of diagnosis, stage of disease, and their current
treatment. This information will be on a data sheet and should take about 5 minutes to
complete.
Any collected information will be confidential. Each participant will be given a specific
identification number so that confidentiality can be maintained.
This study is partially funded by a research grant from the Blanton Davis Ovarian Cancer
Research Program, in Department of Gynecologic Oncology at M. D. Anderson.
This is an investigational study. About 115 participants will be enrolled in this multicenter
study.
About 60 participants will be enrolled at MD Anderson. Up to 31 will be enrolled at the
Harris Health System.
Study Type
Observational
Primary Outcome
Patient Response to Questionnaire (Spiritual assessments)
Condition
Ovarian Cancer
Intervention
Questionnaire
Study Arms / Comparison Groups
Spirituality Questionnaire
Description: Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
115
Start Date
August 10, 2005
Completion Date
August 31, 2020
Primary Completion Date
August 31, 2020
Eligibility Criteria
Inclusion Criteria:
1. All newly diag Stage II-IV ovarian, primary peritoneal or fallopian tube ca patients
prior to initiating C2 of chemo. (A pt with synchronous primary endometrial ca, or HX
of primary endometrial ca, can participate if these conditions are met: endometrial ca
stage not greater than I-B; no more than superficial myometrial invasion, w/o vascular
or lymphatic invasion; no poorly differentiated subtypes, incl papillary serous, clear
cell or other FIGO G3 lesions; no add'l tx other than req for ovarian, prim.
peritoneal or fallopian tube ca is recommended.)
2. Patients who receive neoadjuvant chemotherapy (prior to a planned interval
cytoreduction for a suspected ovarian, primary peritoneal or fallopian tube cancer)
are also eligible as long as there is pathologic confirmation of cancer prior to study
enrollment.
Exclusion Criteria:
1. Patients who do not speak or read English or Spanish.
2. Patients with Stage I ovarian, primary peritoneal or fallopian tube cancer or patients
with tumors of low malignant potential or borderline tumors.
3. Patients with synchronous primary endometrial cancer, or a past history of primary
endometrial cancer, who do not meet the criteria listed above.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Lois M. Ramondetta, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00499512
Organization ID
2004-0283
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
The Blanton Davis Ovarian Cancer Research Program
Study Sponsor
Lois M. Ramondetta, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
January 2020