Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy (PREBCA)

March 31, 2021 updated by: Umut Bahçacı, Hacettepe University

Effects of Progressive Relaxation Training on Artralgia, Quality of Life and Emotional Status in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34349
        • Florence Nightingale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Using Aromatase Inhibitors for more than 6 months
  • Diagnosis of breast cancer stage 1-3
  • Postmenopausal woman aged under 70 years and with hormone-receptor positive
  • Approval of physician for participating in PRE program

Exclusion Criteria:

  • Participation on a regular physical training in the previous 6 months period
  • Communication problems
  • Neurological or ortopedical problems
  • Presence of lyphedema diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / 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: Progressive relaxation exercises

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.
No Intervention: Control Group
Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief pain inventory (BPI)
Time Frame: 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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Time Frame: 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
7 days
Hospital Anxiety and Depression scale (HAD)
Time Frame: 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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Umut Bahcacı, MSc, Florence Nightingale Hospital, Istanbul
  • Principal Investigator: Zeynep Erdoğan İyigün, Asst. Prof., Florence Nightingale Hospital, Istanbul
  • Principal Investigator: Songul Atasavun Uysal, Prof., Hacettepe University
  • Principal Investigator: Çetin Ordu, Asst. Prof., Florence Nightingale Hospital, Istanbul
  • Study Chair: Vahit Özmen, Prof., Florence Nightingale Hospital, Istanbul
  • Study Chair: Gürsel Remzi Soybir, Prof., Memorial Etiler Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

September 24, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREBCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a recent plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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