CClinicalTrials.gg
Status unknownNCT00499512Updated Jan 10, 2020

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

An observational study in Ovarian Cancer, Peritoneal Cancer and Fallopian Tube Cancer, sponsored by M.D. Anderson Cancer Center. Status unknown at 4 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
115
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer

Keywords

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

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 115 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
115 participants (actual)

Groups and cohorts

  • Spirituality Questionnaire

    Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    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).

    Also known as: Survey

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What researchers measure

Primary outcomes

  1. Patient Response to Questionnaire (Spiritual assessments)

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

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Study locations

4 sites
  • Lyndon B. Johnson General Hospital
    Houston, Texas 77030, United States
  • St. Luke's Episcopal Hospital
    Houston, Texas 77030, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • The Woman's Hospital of Texas
    Houston, Texas 77054, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00499512
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
The Blanton Davis Ovarian Cancer Research Program
Responsible party
Sponsor
First posted
Jul 11, 2007
Start date
Aug 10, 2005
Primary completion
Aug 31, 2020 (estimated)
Completion
Aug 31, 2020 (estimated)
Last update
Jan 10, 2020

Study contacts

Lois M. Ramondetta, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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