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


N/A
18 Years
N/A
Open (Enrolling)
Female
Hot Flashes

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hot Flash Frequency

Outcome Time Frame:

Baseline, 8 weeks, and 16 weeks

Safety Issue:

No

Principal Investigator

Janet S Carpenter, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0803-13

NCT ID:

NCT00819182

Start Date:

May 2008

Completion Date:

March 2013

Related Keywords:

  • Hot Flashes
  • Menopause
  • Breast Cancer
  • Hot Flash
  • Night Sweats
  • Hot Flashes

Name

Location

Indiana University School of NursingIndianapolis, Indiana  46202