NCT00499512

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

15.1 years

First QC Date

July 10, 2007

Last Update Submit

January 8, 2020

Conditions

Keywords

Ovarian CancerPeritoneal CancerFallopian Tube CancerSpiritualityReligionQuality of LifeQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Patient Response to Questionnaire (Spiritual assessments)

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

Study Arms (1)

Spirituality Questionnaire

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

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

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
Spirituality Questionnaire

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.)
  • 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.

You may not qualify if:

  • Patients who do not speak or read English or Spanish.
  • Patients with Stage I ovarian, primary peritoneal or fallopian tube cancer or patients with tumors of low malignant potential or borderline tumors.
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, who do not meet the criteria listed above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lyndon B. Johnson General Hospital

Houston, Texas, 77030, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lois M. Ramondetta, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

August 10, 2005

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations