NCT00819182

Brief Summary

Background: Paced respiration has been internationally recommended for vasomotor symptom management despite limited empirical evidence. Objective: To evaluate efficacy of a paced respiration intervention against a sham comparator breathing control and usual care control for vasomotor and other menopausal symptoms. Design: A 16-week, 3-group, partially blinded, controlled trial with 2:2:1 randomization and stratification by group (breast cancer, no cancer), Midwestern city and surrounding area. Participants: 218 randomized women (96 breast cancer survivors, 122 menopausal women without cancer) recruited through community mailings and registries. Interventions: Training, home practice support, and instructions to use the breathing at the time of each hot flash were delivered via compact disc with printed booklet (paced respiration intervention) or digital videodisc with printed booklet (fast shallow breathing control). Usual care control received a letter regarding group assignment. Main Measures: Hot flash frequency, severity, and bother (primary), hot flash interference in daily life, perceived control over hot flashes, and mood and sleep disturbances (secondary). Intervention performance, adherence, and adverse events were assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

March 24, 2016

Status Verified

February 1, 2016

Enrollment Period

3.2 years

First QC Date

January 7, 2009

Results QC Date

May 1, 2013

Last Update Submit

February 24, 2016

Conditions

Hot Flashes

Keywords

MenopauseBreast CancerHot FlashNight Sweats

Outcome Measures

Primary Outcomes (3)

  • Hot Flash Frequency

    Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.

    16 weeks

  • Hot Flash Severity

    Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.

    16 weeks

  • Hot Flash Bother

    Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.

    16 weeks

Secondary Outcomes (4)

  • Hot Flash Related Daily Interference

    16 weeks

  • Perceived Control Over Hot Flashes

    16 weeks

  • Mood Disturbance

    16 weeks

  • Sleep Disturbance

    16 weeks

Other Outcomes (3)

  • Intervention Performance

    2 weeks

  • Intervention Performance

    16 weeks

  • Intervention Adherence

    16 weeks

Study Arms (3)

Paced respiration

EXPERIMENTAL

The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations (4). They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies (5, 6). The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.

Behavioral: Paced respiration

Sham comparator: Fast, shallow breathing

SHAM COMPARATOR

The sham comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash. A previously published report provides additional details and data indicating this program was a suitable attention control.

Behavioral: Sham comparator: fast shallow breathing

Control: Usual Care

NO INTERVENTION

The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.

Interventions

Paced respirationBEHAVIORAL

Breathing exercise

Paced respiration
Sham comparator: fast shallow breathingBEHAVIORAL

sham breathing exercise

Sham comparator: Fast, shallow breathing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Reporting daily hot flashes and desirous of hot flash treatment
  • Peri- or post menopausal
  • Living within a 60-mile radius of Indianapolis or willing to drive to the center for all study visits
  • Able to read, write, and speak English
  • in good general health
  • In addition:
  • Breast Cancer survivors will have a known diagnosis of non-metastatic disease
  • No history of other cancers
  • Be at least four weeks post-completion of surgery, radiation and chemotherapy

You may not qualify if:

  • Known psychiatric disorders or cognitive impairments
  • Participation in our previous pilot study evaluating our control condition
  • Self-reported difficulties with normal everyday breathing
  • Meet criteria at baseline for number of subjective and/or objective hot flashes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Carpenter JS, Burns DS, Wu J, Otte JL, Schneider B, Ryker K, Tallman E, Yu M. Paced respiration for vasomotor and other menopausal symptoms: a randomized, controlled trial. J Gen Intern Med. 2013 Feb;28(2):193-200. doi: 10.1007/s11606-012-2202-6.

    PMID: 22936289RESULT

MeSH Terms

Conditions

Hot FlashesBreast Neoplasms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Janet S Carpenter, PhD, RN, FAAN
Organization
Indiana University
carpentj@iupui.edu
317-278-6093

Study Officials

  • Janet S Carpenter, PhD, RN

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2011

Study Completion

February 1, 2013

Last Updated

March 24, 2016

Results First Posted

February 28, 2014

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

De-identified data available upon request.

Locations

US(1)