MDACC Study Summary 2004-0283

Study Summary
No. 2004-0283:.......Ovary......Lois M. Ramondetta......Gynecologic Oncology

Study Summary Title



Study Summary Number:	2004-0283

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

Physician

New Patient Referral



Name:	Lois M. Ramondetta	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-5238 Contact us about clinical trials

General Information



Disease Group:	Ovary	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	No return visits required, patients may complete surveys by mail.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	MDACC + Community Programs (CCOP/Network)

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary objectives of this exploratory study are:

To describe changes over time in spiritual assessments in women with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer from diagnosis, completion of primary chemotherapy (approx 5-6 months after diagnosis) and one year after completion of primary chemotherapy.

To compare spiritual assessments of women with ovarian, primary peritoneal or fallopian tube cancer who have recurred to women who have not recurred.

Secondary objectives include:
a) Evaluate changes in assessments of hope, predetermination, locus of control, and survivorship
b) Assess relationships between spirituality and religiosity, religion, race, age, and marital status in women with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.
c) Assess changing relationships between spirituality and quality of life, anxiety, and depression in women with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.

Study Status Information



Study Activation / Registration Date:	08/10/2005

IRB Review and Approval Date:	06/21/2005

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	115

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00499512
Study Information on Clinical Trials Registry (clinicaltrials.gov)