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Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00499512
Recruitment Status : Active, not recruiting
First Posted : July 11, 2007
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Behavioral: Questionnaire

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 Design

Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Actual Study Start Date : August 2005
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Spirituality Questionnaire
Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.
Behavioral: Questionnaire
Questionnaires that ask questions about religion, spirituality, and decisions about treatment at three points (at time of diagnosis, end of primary chemotherapy, and one year later).
Other Name: Survey


Outcome Measures

Primary Outcome Measures :
  1. Patient Response to Questionnaire (Spiritual assessments) [ Time Frame: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499512


Locations
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
The Woman's Hospital of Texas
Houston, Texas, United States, 77054
Sponsors and Collaborators
M.D. Anderson Cancer Center
The Blanton Davis Ovarian Cancer Research Program
Investigators
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499512     History of Changes
Other Study ID Numbers: 2004-0283
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Spirituality
Religion
Quality of Life
Questionnaire
Survey

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases