Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy
NCT ID: NCT04163692
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2019-10-25
2020-09-24
Brief Summary
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Hypothesis: Progressive relaxation exercises improve the pain, quality of life and emotional status in breast cancer patients receiving aromatase inhibitor therapy.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Exercise Group
Progressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks
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.
Control Group
Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Communication problems
* Neurological or ortopedical problems
* Presence of lyphedema diagnosis
30 Years
70 Years
FEMALE
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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Umut Bahçacı
Principal investigator
Principal Investigators
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Umut Bahcacı, MSc
Role: PRINCIPAL_INVESTIGATOR
Florence Nightingale Hospital, Istanbul
Zeynep Erdoğan İyigün, Asst. Prof.
Role: PRINCIPAL_INVESTIGATOR
Florence Nightingale Hospital, Istanbul
Songul Atasavun Uysal, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Çetin Ordu, Asst. Prof.
Role: PRINCIPAL_INVESTIGATOR
Florence Nightingale Hospital, Istanbul
Vahit Özmen, Prof.
Role: STUDY_CHAIR
Florence Nightingale Hospital, Istanbul
Gürsel Remzi Soybir, Prof.
Role: STUDY_CHAIR
Memorial Etiler Health Center
Locations
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Florence Nightingale Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Cuzick J, Sestak I, Forbes JF, Dowsett M, Knox J, Cawthorn S, Saunders C, Roche N, Mansel RE, von Minckwitz G, Bonanni B, Palva T, Howell A; IBIS-II investigators. Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Lancet. 2014 Mar 22;383(9922):1041-8. doi: 10.1016/S0140-6736(13)62292-8. Epub 2013 Dec 12.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.
Mincey BA, Duh MS, Thomas SK, Moyneur E, Marynchencko M, Boyce SP, Mallett D, Perez EA. Risk of cancer treatment-associated bone loss and fractures among women with breast cancer receiving aromatase inhibitors. Clin Breast Cancer. 2006 Jun;7(2):127-32. doi: 10.3816/CBC.2006.n.021.
Bender CM, Sereika SM, Brufsky AM, Ryan CM, Vogel VG, Rastogi P, Cohen SM, Casillo FE, Berga SL. Memory impairments with adjuvant anastrozole versus tamoxifen in women with early-stage breast cancer. Menopause. 2007 Nov-Dec;14(6):995-8. doi: 10.1097/gme.0b013e318148b28b.
Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A; ATAC Trialistsa9 Group. Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat. 2006 Dec;100(3):273-84. doi: 10.1007/s10549-006-9260-6. Epub 2006 Jun 21.
Breckenridge LM, Bruns GL, Todd BL, Feuerstein M. Cognitive limitations associated with tamoxifen and aromatase inhibitors in employed breast cancer survivors. Psychooncology. 2012 Jan;21(1):43-53. doi: 10.1002/pon.1860. Epub 2010 Oct 21.
So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009 Jul;36(4):E205-14. doi: 10.1188/09.ONF.E205-E214.
Related Links
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incidence of breast cancer
Other Identifiers
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PREBCA
Identifier Type: -
Identifier Source: org_study_id
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