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


N/A
N/A
N/A
Open (Enrolling)
Female
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

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


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 M. D. Anderson.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Patient Response to Questionnaire (Spiritual assessments)

Outcome Time Frame:

From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy.

Safety Issue:

No

Principal Investigator

Lois M. Ramondetta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0283

NCT ID:

NCT00499512

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Spirituality
  • Religion
  • Quality of Life
  • Questionnaire
  • Survey
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030
St. Luke's Episcopal HospitalHouston, Texas  77030
Lyndon B. Johnson General HospitalHouston, Texas  77026-1967
The Woman's Hospital of TexasHouston, Texas  77054