Clinical trial NCT00499512: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Spirituality
Religion
Quality of Life
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: The Blanton Davis Ovarian Cancer Research Program
First posted: 2007-07-11
Enrollment: 115
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed 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.

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.

Primary outcomes:
measure: Patient Response to Questionnaire (Spiritual assessments)
timeFrame: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lois M. Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References: