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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.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: July 10, 2007   Last Updated: September 9, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499512
  Purpose

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.

Condition Intervention
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 115
Study Start Date: August 2005
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Spirtuality 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).

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 M. D. Anderson.

  Eligibility

Genders 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499512

Contacts
Contact: Lois M. Ramondetta, MD 713-745-5238

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Lois M. Ramondetta, MD            
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
The Woman's Hospital of Texas Recruiting
Houston, Texas, United States, 77054
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Lois M. Ramondetta, MD/Associate Professor )
Study ID Numbers: 2004-0283
Study First Received: July 10, 2007
Last Updated: September 9, 2009
ClinicalTrials.gov Identifier: NCT00499512     History of Changes
Health Authority: United States: Institutional Review Board

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:
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009