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Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
This study is currently recruiting participants.
Study NCT00499512   Information provided by M.D. Anderson Cancer Center
First Received: July 10, 2007   Last Updated: September 9, 2009   History of Changes

July 10, 2007
September 9, 2009
August 2005
August 2010   (final data collection date for primary outcome measure)
Patient Response to Questionnaire (Spiritual assessments) [ Time Frame: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy. ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00499512 on ClinicalTrials.gov Archive Site
 
 
 
Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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.

Primary Objectives:

  1. 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 (approximately 5-6 months after diagnosis), and one year after completion of primary chemotherapy.
  2. 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:

  1. Evaluate changes in assessments of hope, predetermination, locus of control, and survivorship.
  2. Assess relationships between spirituality and religiosity, religion, race, age, and marital status in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.
  3. Assess changing relationships between spirituality and quality of life, anxiety, and depression in women with newly diagnosed 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.

 
Observational
Case-Only, Prospective
  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
Behavioral: Questionnaire
Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
115
 
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All newly diagnosed Stage II-IV ovarian, primary peritoneal, or fallopian tube cancer patients prior to initiating C2 of chemo. A patient with synchronous primary endometrial cancer, or HX of primary endometrial cancer, can participate if these conditions are met:

    • Endometrial cancer stage not greater than I-B
    • No more than superficial myometrial invasion, without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO G3 lesions
    • No additional tx other than required for ovarian, primary peritoneal, or fallopian tube cancer 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.
Female
 
No
Contact: Lois M. Ramondetta, MD 713-745-5238
United States
 
NCT00499512
Lois M. Ramondetta, MD/Associate Professor, U.T.M.D. Anderson Cancer Center
2004-0283
M.D. Anderson Cancer Center
 
Principal Investigator: Lois M. Ramondetta, MD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP