Ovarian, Fallopian, and Primary Peritoneal CancerNCT01790789
Stress Reduction in Ovarian Cancer
A study testing Daily stress reduction program in people with Ovarian, Fallopian, and Primary Peritoneal Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian, Fallopian, and Primary Peritoneal Cancer
- What is being tested?
- Daily stress reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 6 Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS).
- Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS.
- Receive chemotherapy at the University of Wisconsin-Madison.
- Subjects must be at least 18 years of age.
- English-speaking
- Subjects must be able to use audio media, and read and understand the study manual.
- ECOG performance status 0-2.
- Subjects must have a phone.
Who cannot join
- Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration.
- Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer.
- Subjects with diagnosis of Chronic Fatigue Syndrome (CFS).
- Subjects unable to use audio media due to auditory dysfunction.
- Subjects unable to read written English.
- Subjects who are prisoners or incarcerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer
The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.
- Being tested
- Daily stress reduction program, Attention control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily stress reduction programBehavioural
Subjects will participate in activities of a daily stress reduction program.
Attention controlOther
Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Stress reduction program | Experimental | Not described Receives: Behavioral: Daily stress reduction program |
| Attention control | Other | Not described Receives: Other: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument
Measured: 18 weeks (completion of chemotherapy)
Secondary outcomes (1)
Natural Killer Cell Activity
Cytotoxicity assays will be conducted to determine if the meditation-based intervention results in an increase in the ability of the NK cells to recognize and lyse cancer targets.
Measured: 18 weeks (completion of chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion9 Aug 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian, Fallopian, and Primary Peritoneal CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Rose, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790789
- Sponsor's protocol ID
- 2013-0027
- Other IDs
- OS12706, 2013-0027, A532800, SMPH\OBSTET & GYNECOL\OB-GYN, NCI-2013-01401
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2013
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01790789
- Acronym / sponsor ID
- 2013-0027
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 13 Feb 2013 (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 purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress reduction program | Experimental | Behavioral: Daily stress reduction program |
| Attention control | Other | Other: Attention control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS).
- Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS.
- Receive chemotherapy at the University of Wisconsin-Madison.
- Subjects must be at least 18 years of age.
- English-speaking
Key exclusion criteria (6 listed)
- Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration.
- Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer.
- Subjects with diagnosis of Chronic Fatigue Syndrome (CFS).
- Subjects unable to use audio media due to auditory dysfunction.
- Subjects unable to read written English.
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 |
|---|---|---|
| Daily stress reduction programSubjects will participate in activities of a daily stress reduction program. | Behavioural | Stress reduction program |
| Attention controlSubjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study. | Other | Attention control |
Primary outcome
Fatigue
Time frame: 18 weeks (completion of chemotherapy)
Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument
1 secondary outcome
Natural Killer Cell Activity
Time frame: 18 weeks (completion of chemotherapy)
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 19 Nov 2019.
- University of Wisconsin Carbone 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.
Stephen Rose, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily stress reduction program in people with Ovarian, Fallopian, and Primary Peritoneal Cancer, run by University of Wisconsin, Madison 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 8 inclusion and 6 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 19 Nov 2019. 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 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?
Fatigue (time frame: 18 weeks (completion of chemotherapy)). 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 Nov 2019.