PsychosocialNCT00473798
Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer
An observational study of Psychosocial and Cervical Cancer, run by M.D. Anderson Cancer Center at 5 sites in 2 countries.
Trial summary
Primary Objectives: 1. To compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the screening setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychosocial, Cervical Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,938 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 1999to 5 Jun 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy. Total Accrual for Study A: 3510; Study A': 350; pilot tests for Study A': 120; Study B: 360; and Study C: 645. Health care providers will participate in Study D with a total accrual of 900.
Who may be able to join
- Studies A, A', and pilot tests
- Eligible to participate in Project 2
- Over 18
- Referred for an abnormal pap or has no history of abnormal pap
- Consented to participate in the patient outcomes project.
- Study B
Show all 14Show fewer
- Consented to participate in Project 3
- Over 18
- Referred for an abnormal pap
- Consented to participate in the patient outcome project.
- Study C
- Same as Study B.
- Study D
- Members of the American Society for Colposcopy and Cervical Pathology (ASCCP).
Who cannot join
- Studies A, A', and pilot tests through C:
- Pregnancy
- Unable to communicate in English, Spanish, or Chinese
- Study D
- None
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Hermann Professional Building Clinic
Houston, Texas, 77030
LBJ Hospital
Houston, Texas, 77030
Texas Medical Center Clinic
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Canada1 site
Vancouver General Hospital/British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
Primary Objectives:
- To compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the screening setting. This aim will be addressed in Studies A and A' -- Procedure-Related Distress and Patient Satisfaction.
- To evaluate differences in psychological distress, satisfaction, and adherence to treatment in the two arms of a randomized trial; one group will be diagnosed with usual care procedures (Papanicolaou smear and colposcopically-directed biopsy) plus optical spectroscopy and the second will receive usual care. Aim 2 will be accomplished in Study B -- Psychological Distress, Satisfaction, and Adherence Outcomes in a Randomized Trial of Optical Spectroscopy.
- To assess the psychosocial and behavioral impact of a false positive screening result. This will be done in Study C -- Impact of False Positive Screening Test on Psychological Distress and Future Screening Intentions.
- To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in Study D -- Survey of Health Care Providers.
Read the detailed description
Randomized Clinical Trial:
Participants in this study will be interviewed before and after they see the doctor for their first visit. They will be asked about their moods and the tests used to detect cervical cancer. They will also be asked about their symptom, how it is affecting their lives, and their satisfaction with their visit.
Participants will be called approximately 2 weeks, 6 weeks, and 3 months after their appointments to answer questions about their health and quality of life, and the test and treatment they received. In addition, the participants will complete assessments at the 6, 12, 18, and 24 month clinic visits. If participants do not return for these follow-up appointments, the research staff will attempt to contact the participants to do brief interview by phone.
Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence.
This is an investigational study. A total of 360 patients will take part in this multicenter study. About 180 participants at M. D. Anderson will take part in this study.
Studies A and A Prime:
Participants in this study will be interviewed before they see the doctor. They will be asked about their moods and the tests used to detect cervical cancer.
During the medical tests, participants will rate their pain and how tense they are. Someone will watch them to see whether they are upset or in pain. After they see the doctor, participants will be interviewed again about their mood and how much they liked or did not like the test.
Some participants will be interviewed about their opinion of the test at the appointment when they receive their test results. Some participants will complete the Sequelae of LEEP/biopsy and medication use questionnaire. Some participants will be called 7 to 14 days and/or three months after their appointments. Some participants may answer some of the questions on a computer as well as in an interview. They will be asked to answer questions about their moods and about getting tests to detect cervical cancer. A sample of the participants will be selected to have their results visit tape recorded and to answer a few questions about what the doctor told them.
Participants may be contacted to participate in discussion groups about tests for cervical dysplasia. Participation in the discussion groups is voluntary. Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence.
This is an investigational study. A total of 3980 patients will take part in this multicenter study. About 2400 participants at M. D. Anderson will take part in this study.
- Conditions
- Psychosocial, Cervical Cancer
- Being tested
- Questionnaire
- Keywords
- Patient Satisfaction, Quality of Life, Psychological Distress, Cervical Cancer, Cervical Cancer Screening, Questionnaire
- Medical subject headings
- Uterine Cervical Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| A | Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. Receives: Behavioral: Questionnaire | |
| A' | Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. Receives: Behavioral: Questionnaire | |
| B | Patients who have consented to participate in a randomized trial of optical spectroscopy. Receives: Behavioral: Questionnaire | |
| C | Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. Receives: Behavioral: Questionnaire | |
| D | Health care providers. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy
Measured: 9 Years
Evaluate differences in psychological distress, satisfaction, and adherence to treatment.
Measured: 9 Years
Secondary outcomes (2)
Assess the psychosocial and behavioral impact of a false positive screening result.
Measured: 9 Years
Assess provider receptivity to optical spectroscopy
Measured: 9 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study start1 Jul 1999
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosocialStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473798
- Sponsor's protocol ID
- BS98-269
- Status last verified
- Jun 2020
- First submitted
- 14 May 2007
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Psychological Distress Related to Emerging Technologies for Cervical Cancer Screening and Diagnosis
- ClinicalTrials.gov ID
- NCT00473798
- Acronym / sponsor ID
- BS98-269
- Conditions
- Psychosocial, Cervical Cancer
- Keywords
- Patient Satisfaction, Quality of Life, Psychological Distress, Cervical Cancer, Cervical Cancer Screening, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,938 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 1999 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 16 May 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.
Primary Objectives:
- To compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy in the cervical cancer diagnostic setting and with Papanicolaou smear in the screening setting. This aim will be addressed in Studies A and A' -- Procedure-Related Distress and Patient Satisfaction.
- To evaluate differences in psychological distress, satisfaction, and adherence to treatment in the two arms of a randomized trial; one group will be diagnosed with usual care procedures (Papanicolaou smear and colposcopically-directed biopsy) plus optical spectroscopy and the second will receive usual care. Aim 2 will be accomplished in Study B -- Psychological Distress, Satisfaction, and Adherence Outcomes in a Randomized Trial of Optical Spectroscopy.
- To assess the psychosocial and behavioral impact of a false positive screening result. This will be done in Study C -- Impact of False Positive Screening Test on Psychological Distress and Future Screening Intentions.
- To assess provider receptivity to optical spectroscopy. Aim 4 will be accomplished in Study D -- Survey of Health Care Providers.
Detailed description
Randomized Clinical Trial:
Participants in this study will be interviewed before and after they see the doctor for their first visit. They will be asked about their moods and the tests used to detect cervical cancer. They will also be asked about their symptom, how it is affecting their lives, and their satisfaction with their visit.
Participants will be called approximately 2 weeks, 6 weeks, and 3 months after their appointments to answer questions about their health and quality of life, and the test and treatment they received. In addition, the participants will complete assessments at the 6, 12, 18, and 24 month clinic visits. If participants do not return for these follow-up appointments, the research staff will attempt to contact the participants to do brief interview by phone.
Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence.
This is an investigational study. A total of 360 patients will take part in this multicenter study. About 180 participants at M. D. Anderson will take part in this study.
Studies A and A Prime:
Participants in this study will be interviewed before they see the doctor. They will be asked about their moods and the tests used to detect cervical cancer.
During the medical tests, participants will rate their pain and how tense they are. Someone will watch them to see whether they are upset or in pain. After they see the doctor, participants will be interviewed again about their mood and how much they liked or did not like the test.
Some participants will be interviewed about their opinion of the test at the appointment when they receive their test results. Some participants will complete the Sequelae of LEEP/biopsy and medication use questionnaire. Some participants will be called 7 to 14 days and/or three months after their appointments. Some participants may answer some of the questions on a computer as well as in an interview. They will be asked to answer questions about their moods and about getting tests to detect cervical cancer. A sample of the participants will be selected to have their results visit tape recorded and to answer a few questions about what the doctor told them.
Participants may be contacted to participate in discussion groups about tests for cervical dysplasia. Participation in the discussion groups is voluntary. Research staff will also review participant's medical records and gather information on diagnosis, treatment plans and adherence.
This is an investigational study. A total of 3980 patients will take part in this multicenter study. About 2400 participants at M. D. Anderson will take part in this study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: QuestionnaireWomen who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. |
| A' | – | Behavioral: QuestionnaireWomen who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. |
| B | – | Behavioral: QuestionnairePatients who have consented to participate in a randomized trial of optical spectroscopy. |
| C | – | Behavioral: QuestionnaireWomen who are eligible to participate in a study of the technical feasibility of optical spectroscopy will be invited to participate in this study. |
| D | – | Behavioral: QuestionnaireHealth care providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are eligible to participate in a study of the technical feasibility of optical spectroscopy. Total Accrual for Study A: 3510; Study A': 350; pilot tests for Study A': 120; Study B: 360; and Study C: 645. Health care providers will participate in Study D with a total accrual of 900.
Key inclusion criteria (14 listed)
- Studies A, A', and pilot tests
- Study B
- Study C
- Study D
Key exclusion criteria (5 listed)
- Studies A, A', and pilot tests through C:
- Study D
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 |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | A, A', B, C, D |
Primary outcome
Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy
Time frame: 9 Years
Evaluate differences in psychological distress, satisfaction, and adherence to treatment.
Time frame: 9 Years
2 secondary outcomes
Assess the psychosocial and behavioral impact of a false positive screening result.
Time frame: 9 Years
Assess provider receptivity to optical spectroscopy
Time frame: 9 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- 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.
Karen Basen-Engquist, PhD principal investigator
M.D. Anderson Cancer Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial and Cervical Cancer, run by M.D. Anderson Cancer Center at 5 sites in 2 countries.
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 14 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare levels of patient anxiety, pain, and satisfaction associated with optical spectroscopy procedures and MDC with the levels associated with colposcopically-directed biopsy (time frame: 9 Years). The study lists 2 primary outcomes in all. 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 12 Jun 2020.