Breathe for Hot Flashes Randomized Controlled Trial

Hot Flashes Clinical Trial

Official title:

Breathe-intervention for Hot Flashes, Associated Outcomes, and Interference

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819182
• Other study ID #: 0803-13
• Secondary ID: R01CA132927
• Status: Completed
• Phase: N/A
• First received: January 7, 2009
• Last updated: January 14, 2014
• Start date: April 2008
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: February 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Behavioral:
• Paced respiration
Breathing exercise

Locations

Country	Name	City	State
United States	Indiana University School of Nursing	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Performance	Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.	2 weeks	No
Other	Intervention Performance	Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.	16 weeks	No
Other	Intervention Adherence	Number of breathing practice sessions per participant over the 16 week study period.	16 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Hot Flash Related Daily Interference	Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.	16 weeks	No
Secondary	Perceived Control Over Hot Flashes	Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.	16 weeks	No
Secondary	Mood Disturbance	Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.	16 weeks	No
Secondary	Sleep Disturbance	Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.	16 weeks	No