Breathe for Hot Flashes Randomized Controlled Trial

NCT ID: NCT00819182

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-02-28

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.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Paced respiration

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.

Group Type: EXPERIMENTAL

Paced respiration

Intervention Type: BEHAVIORAL

Breathing exercise

Sham comparator: Fast, shallow breathing

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.

Group Type: SHAM_COMPARATOR

Sham comparator: fast shallow breathing

Intervention Type: BEHAVIORAL

sham breathing exercise

Control: Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paced respiration

Breathing exercise

Intervention Type: BEHAVIORAL

Sham comparator: fast shallow breathing

sham breathing exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet S Carpenter, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Nursing

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22936289 (View on PubMed)

Other Identifiers

R01CA132927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0803-13

Identifier Type: -

Identifier Source: org_study_id