Stress Reduction in Ovarian Cancer | NCT01790789

Studies
Stress Reduction in Ovarian Cancer

NCT01790789

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Ovarian, Fallopian, and Primary Peritoneal Cancer

Interventions

Daily stress reduction program
Attention control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
OS12706	Other Identifier	University of Wisconsin Carbone Cancer Center
2013-0027	Other Identifier	Institutional Review Board
A532800	Other Identifier	UW Madison
SMPH\OBSTET & GYNECOL\OB-GYN	Other Identifier	UW Madison
NCI-2013-01401	Registry Identifier	NCI Trial ID

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013Actual

Primary Completion Date

Aug 9, 2016Actual

Completion Date

Dec 6, 2016Actual

First Submitted Date

Feb 8, 2013

First Submission Date that Met QC Criteria

Feb 11, 2013

First Posted Date

Feb 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2019

Last Update Posted Date

Nov 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress reduction program	Experimental		Behavioral: Daily stress reduction program
Attention control	Other		Other: Attention control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily stress reduction program	Behavioral	Subjects will participate in activities of a daily stress reduction program.	Stress reduction program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue	Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument	18 weeks (completion of chemotherapy)

Secondary Outcomes

Measure	Description	Time Frame
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.	18 weeks (completion of chemotherapy)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Rose, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin School of Medicine and Public Health		Madison	Wisconsin	53792	United States