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Effects of Progressive Relaxation Training in Breast Cancer Survivors Receiving Aromatatase Inhibitor Therapy

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Hacettepe University

Keywords

Abstract

This study evaluates the effects of progressive relaxation exercises on artralgia, quality of life and anxiety in breast cancer survivors receiving aromatase inhibitors. Half of the participants will receive supervised progressive relaxing exercises, while other half will not receive any exercise but only advice about relaxing.

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.(15) PRE was thought to be effective on artralgia, quality of life and anxiety in BC survivors receiving AI.

The patients have been founded from the medical records of oncology department of Florence Nightingale Hospital. Necessary permissions to use this data was provided from medical coordinator of the hospital and from the coordinator of Breast Cancer department.

Dates

Last Verified: 04/30/2020
First Submitted: 11/11/2019
Estimated Enrollment Submitted: 11/11/2019
First Posted: 11/14/2019
Last Update Submitted: 05/03/2020
Last Update Posted: 05/05/2020
Actual Study Start Date: 10/24/2019
Estimated Primary Completion Date: 07/31/2020
Estimated Study Completion Date: 08/31/2020

Condition or disease

Breast Cancer

Intervention/treatment

Other: Exercise Group

Phase

-

Arm Groups

ArmIntervention/treatment
Experimental: Exercise Group
Progressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks
Other: Exercise Group
Following intructions have been given to 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.
No Intervention: Control Group
Information about pain and its treatment and the importance of relaxing exercises without any intervention..

Eligibility Criteria

Ages Eligible for Study 30 Years To 30 Years
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- Using Aromatase Inhibitors for more than 6 months

- Diagnosis of breast cancer stage 1-3

- Pain score ≥3 according to the Brief Pain Inventory

Exclusion Criteria:

- Participation on physical training in the previous 6 months period

- Communication problems

- Neurological or ortopedical problems

- Presence of advanced lyphedema

Outcome

Primary Outcome Measures

1. Brief pain inventory (BPI) [24 hours]

Assesses the severity of pain and its impact on functioning. Consisting of 17 questions, evaluating pain location, severity, and pain status, especially in the last 24 hours. Scores of 3-4 are defined as mild, 5-7 as moderate, 8-10 as severe pain in this scale.

Secondary Outcome Measures

1. Functional Assessment of Chronic Illness Therapy - Breast (FACT-B) [7 days]

Evaluates the multidimensionel quality of life in patients with breast cancer and is available in many languages . The questionnaire includes 5 sub-scales that assess physical, social, emotional, functional and other anxiety status. It has 27-item general and 10-item breast cancer specific scale in which patients evaluate their status. Patients determine an appropriate expression for themselves in the last 7 days, with a 5 point scale as 0: none, 1: very little, 2: slightly, 3: quite, 4: too much. Higher scores indicate higher quality of life

2. Hospital Anxiety and Depression scale (HAD) [7 days]

Consists of 14 questions which 7 of them evaluate depression and 7 of them evaluate anxiety. The cut-off score is 10/11 for the anxiety subscale and 7/8 for the depression subscale

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