Ovarian CancerNCT00813254
Cost Utility Analysis in Recurrent Ovarian Cancer
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2011
- 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: Female study participants that were diagnosed with Ovarian Cancer that are now "Platinum-Resistant."
Who may be able to join
- Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment
- Patients must be English-speaking
- Patients must be able to read and write English
- Patients receiving all chemotherapy at MD Anderson Cancer Center
Who cannot join
- Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary
- Patients who are receiving protocol therapy
- Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)
- Patients who are receiving radiation therapy as a treatment modality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer
The goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease.
Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment.
In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.
Read the detailed description
Study Participation:
If you agree to take part in this study, medical and demographic information will be collected from your medical record and/or by asking you in person when you come to the clinic for your routine visits. This information includes your date of birth, medical history, occupation, marital status, race, household income, and number of children and/or other dependents (if any).
On Day 1 of your study participation, you will be interviewed by a research staff member. In this interview, you will be asked about your health and any symptoms related to the cancer and/or cancer treatment. You will also be asked for the best way of contacting you. This interview should take about 30 minutes to complete. After the interview, you will complete a set of 5 questionnaires. In total, the questionnaires should take about 15 minutes to complete. You will repeat these same 5 questionnaires on Day 1 of each of your chemotherapy cycles. The questionnaires include the following:
- Questionnaire 1 (The Short Form 12) asks about your physical and emotional health, any pain, social functioning, and general health. This information will help researchers keep track of how you feel and how well you are able to do your usual activities.
- Questionnaire 2 (The Functional Assessment of Cancer Therapy) asks about the symptoms of cancer and how these symptoms may affect your physical, social, and emotional well-being.
- Questionnaire 3 (Medical Outcomes Study) asks about your sexual functioning. Researchers believe this information is important in understanding how health problems affect people's lives.
- Questionnaire 4 (The Functional Assessment of Cancer Therapy/Neurotoxicity questionnaire) asks whether or not you have had any numbness and/or tingling in your hands and/or feet. This numbness/tingling can occur as a side effect of some chemotherapy drugs that are commonly given to patients with ovarian cancer.
- Questionnaire 5 (The Memorial Symptom Assessment Scale) asks about the symptoms of ovarian cancer and the side effects of ovarian cancer treatment.
In addition, you will also be asked to complete the following questionnaires for each cycle of chemotherapy:
- Questionnaire 6 (The Productivity and Activity Impairment General Health questionnaire) asks about how you feel your health status may have affected your and/or your primary caregiver's "productivity" (your ability to perform normal activities) at work and at home.
- Questionnaire 7 (The European Quality of Life instrument) asks a few questions about your health status on that particular day. It also asks you to rate your health status by marking on a scale how good or bad your health is on that day.
- Questionnaire 8 is a diary in which you will record all medical costs (such as any emergency room visits, hospitalizations, doctor's visits, and medications) that you have had to pay for in the last week.
- Questionnaire 9 is a diary in which you will record your treatment-related costs that are not medical (such as travel, child care costs, parking fees, and gasoline).
You can bring the completed Questionnaires 6-9 with you when you return for your next follow-up visit, email, fax or mail them back to the clinic before your next visit. If necessary, you may complete them over the phone instead. In total, Questionnaires 6-9 should take about 7 minutes to complete each time.
Questionnaire Content:
Your responses on these questionnaires will not be shared with the doctor who is treating you for cancer. If you feel you need a doctor's opinion about anything that is asked about in these questionnaires (such as cancer symptoms or mental or emotional difficulties), please contact your doctor.
If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive a mental health screening.
Caregivers' Participation:
Your caregiver will also be asked to complete Questionnaire 6 for each cycle of chemotherapy you receive. Specifically, the caregiver will answer questions about how he or she feels your health status may have affected his or her productivity at work and at home.
Your questionnaires will be used for research purposes only, and your responses will not be shared with the caregiver. Likewise, the caregiver's responses will not be shared with you. You will receive separate return envelopes for mailing back your questionnaires separately from the caregiver's.
Length of Study Participation:
This is a long-term study, and you will remain "on study" for as long as you and the caregiver agree to keep filling out the questionnaires. If you stop receiving treatment for the cancer, your and the caregiver's participation in this study will be over.
This is an investigational study. You will receive stamped, self-addressed envelopes for mailing the questionnaires back to the clinic.
Up to 43 patients and 43 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Ovarian Cancer
- Being tested
- Questionnaire
- Keywords
- Platinum-Resistant Ovarian Cancer, Platinum-based chemotherapy, Ovarian Cancer, Ovary, Epithelial ovarian cancer, Quality of Life, Cost Utility Analysis, Sexual functioning, Questionnaire, Caregiver
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Longitudinal measure of QOL, sexual functioning and symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score for the FACT-O instrument
Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles.
Measured: First 2 days of chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionJan 2011
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M Frumovitz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813254
- Sponsor's protocol ID
- 2007-0611
- Status last verified
- Apr 2012
- First submitted
- 22 Dec 2008
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00813254
- Acronym / sponsor ID
- 2007-0611
- Conditions
- Ovarian Cancer
- Keywords
- Platinum-Resistant Ovarian Cancer, Platinum-based chemotherapy, Ovarian Cancer, Ovary, Epithelial ovarian cancer, Quality of Life, Cost Utility Analysis, Sexual functioning
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Dec 2008 (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 research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease.
Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment.
In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.
Detailed description
Study Participation:
If you agree to take part in this study, medical and demographic information will be collected from your medical record and/or by asking you in person when you come to the clinic for your routine visits. This information includes your date of birth, medical history, occupation, marital status, race, household income, and number of children and/or other dependents (if any).
On Day 1 of your study participation, you will be interviewed by a research staff member. In this interview, you will be asked about your health and any symptoms related to the cancer and/or cancer treatment. You will also be asked for the best way of contacting you. This interview should take about 30 minutes to complete. After the interview, you will complete a set of 5 questionnaires. In total, the questionnaires should take about 15 minutes to complete. You will repeat these same 5 questionnaires on Day 1 of each of your chemotherapy cycles. The questionnaires include the following:
- Questionnaire 1 (The Short Form 12) asks about your physical and emotional health, any pain, social functioning, and general health. This information will help researchers keep track of how you feel and how well you are able to do your usual activities.
- Questionnaire 2 (The Functional Assessment of Cancer Therapy) asks about the symptoms of cancer and how these symptoms may affect your physical, social, and emotional well-being.
- Questionnaire 3 (Medical Outcomes Study) asks about your sexual functioning. Researchers believe this information is important in understanding how health problems affect people's lives.
- Questionnaire 4 (The Functional Assessment of Cancer Therapy/Neurotoxicity questionnaire) asks whether or not you have had any numbness and/or tingling in your hands and/or feet. This numbness/tingling can occur as a side effect of some chemotherapy drugs that are commonly given to patients with ovarian cancer.
- Questionnaire 5 (The Memorial Symptom Assessment Scale) asks about the symptoms of ovarian cancer and the side effects of ovarian cancer treatment.
In addition, you will also be asked to complete the following questionnaires for each cycle of chemotherapy:
- Questionnaire 6 (The Productivity and Activity Impairment General Health questionnaire) asks about how you feel your health status may have affected your and/or your primary caregiver's "productivity" (your ability to perform normal activities) at work and at home.
- Questionnaire 7 (The European Quality of Life instrument) asks a few questions about your health status on that particular day. It also asks you to rate your health status by marking on a scale how good or bad your health is on that day.
- Questionnaire 8 is a diary in which you will record all medical costs (such as any emergency room visits, hospitalizations, doctor's visits, and medications) that you have had to pay for in the last week.
- Questionnaire 9 is a diary in which you will record your treatment-related costs that are not medical (such as travel, child care costs, parking fees, and gasoline).
You can bring the completed Questionnaires 6-9 with you when you return for your next follow-up visit, email, fax or mail them back to the clinic before your next visit. If necessary, you may complete them over the phone instead. In total, Questionnaires 6-9 should take about 7 minutes to complete each time.
Questionnaire Content:
Your responses on these questionnaires will not be shared with the doctor who is treating you for cancer. If you feel you need a doctor's opinion about anything that is asked about in these questionnaires (such as cancer symptoms or mental or emotional difficulties), please contact your doctor.
If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive a mental health screening.
Caregivers' Participation:
Your caregiver will also be asked to complete Questionnaire 6 for each cycle of chemotherapy you receive. Specifically, the caregiver will answer questions about how he or she feels your health status may have affected his or her productivity at work and at home.
Your questionnaires will be used for research purposes only, and your responses will not be shared with the caregiver. Likewise, the caregiver's responses will not be shared with you. You will receive separate return envelopes for mailing back your questionnaires separately from the caregiver's.
Length of Study Participation:
This is a long-term study, and you will remain "on study" for as long as you and the caregiver agree to keep filling out the questionnaires. If you stop receiving treatment for the cancer, your and the caregiver's participation in this study will be over.
This is an investigational study. You will receive stamped, self-addressed envelopes for mailing the questionnaires back to the clinic.
Up to 43 patients and 43 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: QuestionnaireLongitudinal measure of QOL, sexual functioning and symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female study participants that were diagnosed with Ovarian Cancer that are now "Platinum-Resistant."
Key inclusion criteria (4 listed)
- Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment
- Patients must be English-speaking
- Patients must be able to read and write English
- Patients receiving all chemotherapy at MD Anderson Cancer Center
Key exclusion criteria (4 listed)
- Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary
- Patients who are receiving protocol therapy
- Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)
- Patients who are receiving radiation therapy as a treatment modality
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 1 - 5 will be completed on Day 1 of study as a Baseline. | Behavioural | Questionnaire |
Primary outcome
Mean Score for the FACT-O instrument
Time frame: First 2 days of chemotherapy cycles
Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Michael M Frumovitz, MD principal investigator
M.D. Anderson Cancer Center
1 site 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, run by M.D. Anderson Cancer Center at 1 site 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean Score for the FACT-O instrument (time frame: First 2 days of chemotherapy cycles). 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 19 Apr 2012; AzTrials last refreshed its copy on 6 Nov 2026.