Three Different Programs of Paced Breathing in Treating Hot Flashes in Women
Condition: Breast Cancer; Fatigue; Hot Flashes; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Fatigue; Hot Flashes
Study type: Interventional

Summary: 
      RATIONALE: Paced breathing may be an effective way to reduce the number and severity of hot
      flashes in women who have survived breast cancer.

      PURPOSE: This randomized phase II trial is comparing three different programs of paced
      breathing to see how well they work in treating hot flashes in women.
    

Detailed description: 
      OBJECTIVES:

        -  To assess feasibility and obtain initial estimates of efficacy of three different
           programs of paced breathing (15 minutes once a day at 6 breaths/minute vs 15 minutes
           twice a day at 6 breaths/minute vs 10 minutes once a day at 14 breaths/minute) on the
           frequency and severity of hot flashes in breast cancer survivors or patients not
           preferring to take hormones because of concern for breast cancer.

        -  To assess feasibility and obtain initial estimates of efficacy of three different
           programs of paced breathing on mood states, fatigue, sleep quality, and blood pressure
           measurement in breast cancer survivors or patients not preferring to take hormones
           because of concern for breast cancer.

      OUTLINE: Patients are stratified by age (18-49 vs ≥ 50), frequency of hot flashes per day (<
      4 vs 4-9 vs ≥ 10), and current tamoxifen, raloxifene, or aromatase inhibitor treatment (yes
      vs no). Patients are randomized to 1 of 3 treatment arms.

        -  Arm I: Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7
           days weekly, following an instructional compact disc (CD), for 8 weeks.

        -  Arm II: Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7
           days weekly, following an instructional CD, for 8 weeks.

        -  Arm III: Patients practice paced breathing for 10 minutes once daily, 14 breaths /min,
           5-7 days weekly, following an instructional CD, for 8 weeks.

      All patients complete daily hot flash diaries, keep a blood pressure log, and complete the
      following questionnaires: Symptom Experience Diary, Profile of Mood States, Brief Fatigue
      Inventory, and Pittsburgh Sleep Quality Index.
    

Intervention name(s): Paced breathing (15 min once daily, 6 breaths/min); Paced breathing (15 min twice daily, 6 breaths/min); Paced breathing (10 min once daily, 14 breaths/min)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.; Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional CD, for 8 weeks.; Patients practice paced breathing for 10 minutes once daily, 14 breaths /min, 5-7 days weekly, following an instructional CD, for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: fatigue; sleep disorders; ductal breast carcinoma in situ; lobular breast carcinoma in situ; breast cancer; hot flashes