Ovarian CancerNCT00499512
Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
An observational study of Ovarian Cancer and Peritoneal Cancer, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2005to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77054
About this study
Official title: 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.
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.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Questionnaire
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Spirituality, Religion, Quality of Life, Questionnaire, Survey
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
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).
| Study group | Role | What they receive |
|---|---|---|
| Spirituality Questionnaire | Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response to Questionnaire (Spiritual assessments)
Measured: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study start10 Aug 2005
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Blanton Davis Ovarian Cancer Research Program
- Responsible party
- Sponsor
- Investigators
- Lois M. Ramondetta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499512
- Sponsor's protocol ID
- 2004-0283
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2007
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00499512
- Acronym / sponsor ID
- 2004-0283
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Spirituality, Religion, Quality of Life, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- The Blanton Davis Ovarian Cancer Research Program
- Study start
- 10 Aug 2005 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirituality Questionnaire | – | Behavioral: QuestionnairePatients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires 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). | Behavioural | Spirituality Questionnaire |
Primary outcome
Patient Response to Questionnaire (Spiritual assessments)
Time frame: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois M. Ramondetta, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Peritoneal Cancer, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.