Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the effects of progressive relaxation exercises on artralgia, quality of
      life and anxiety-deppression in breast cancer patients receiving aromatase inhibitor. Half of
      the participants will receive supervised progressive relaxing exercises, while other half
      will not receive any exercise but only advice about relaxing.

      Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional
      status in breast cancer patients receiving aromatase inhibitor therapy.
    

Detailed description: 
      Aromatase inhibitors (AI) can cause musculoskeletal problems and increased risk of fracture
      as side effects in breast cancer (BC) survivors. In particular, arthralgia can be observed in
      almost 50% of patients receiving AI. Moreover; cognitive dysfunctions , decreases in quality
      of life , anxiety and depression , sleep problems and fatigue can be seen in some of patients
      receiving AI. According to these possible side effects, evaluation and treatment of such
      health profiles, pain and symptoms is important in terms of improving the quality of life of
      the patients.

      Progressive muscle relaxation exercises (PRE) were first described by Jacobson in 1938. PRE
      are in use today with different arrangements and updates. It was well defined physiological,
      perceptual and behavioral positive findings of muscle relaxation.

      PRE was thought to be effective on artralgia, quality of life and anxiety-depression in BC
      survivors receiving AI.

      The patients have been searched from the medical records of brest health center in a local
      hospital. Necessary permissions to use this data was provided from medical coordinator of the
      hospital and from the coordinator of Breast Health Center.

      The study was conducted as two armed, assessor blinded and randomised controlled trial. BC
      survivors who are receiving AI were randomised to study (performed PRE) or control (no
      intervention) group. Eligible patients were provided information about the the study and
      invited to participate in study via phone call. All assessments and exercise training was
      carried out in Physiotherapy Department of the same hospital. Outcomes were assessed baseline
      and at 6th-week intervention Primary endpoint was pain assessment assessed by Brief Pain
      inventory. Secondary endpoints were quality of life assessed by Functional Assessment of
      Chronic Illness Therapy and emotional status by Hospital Anxiety and Depression scales.

      Statistical analysis Sample size was calculated by using a previous study mentioned the
      impact of yoga on functional outcomes in breast cancer survivors with aromatase
      inhibitor-associated arthralgias. The mean and standart deviation data of the FACT-B
      parameter was used with the power (1-type II error) of 0.80 and a type I error of 0.05.
      Therefore, it was aimed to recruit at least 20 participants per group. In total, with dropout
      rate of 30%, it was estimated to recruit 26 patients in each group.

      Mean [95% confidence intervals (CI)], standard deviations and frequency rates was analyzed
      for baseline charecteristics. Group distributions were examined with the Kolmogorov Simirnov
      test. Groups analysis were performed using the non parametric test methods due to the low
      number of participants. Mann-Whitney U test for the analysis of quantitative independent
      data, and Wilcoxon test was used for the analysis of dependent data. Mc-Nemar Test was used
      for dependent variables and Chi-Square test was used for independent variables in the
      analysis of qualitative data. Cohen's Formula used for calculating efect size of differences
      between and within the groups. Figures are performed by the SPSS graphics. P value <0.05 was
      considered as significant.
    

Intervention name(s): Progressive relaxation exercises
Intervention type(s): Other
Intervention description(s): Following intructions have been performed by patients:
Punch your hands and contract your forearm
Punch your hands, push your elbow towards the seat
Bend your elbows
Push your shoulders back
Press your knee down and pull your toes towards you
Pull your knees towards you and push your feet down
Tighten your hips
Push your head back
Lift your eyebrows
Make wrinkles on your nose
Tighten your teeth
Push your chin down
Close your eyes and think of good things.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A computer generated list of random sequence numbers was created with 1:1 allocation ratio to randomise participants into study or control groups. Randomisation sequence was concealed until assignment of interventions. The group allocation was made by study researcher who implemented the PRE.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Relaxation therapy; Pain; Aromatase Inhibitors