Progressive Relaxation Training in Breast Cancer Patients Receiving Aromatatase Inhibitor Therapy

NCT04163692 | Completed DMC

• 1 other identifier: PREBCA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Relaxation therapy; Pain; Aromatase Inhibitors

Outcome Measures

Primary Outcomes (1)

• Brief pain inventory (BPI)

  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 Outcomes (2)

• Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)

  7 days

• Hospital Anxiety and Depression scale (HAD)

  7 days

Study Arms (2)

Exercise Group

EXPERIMENTAL

Progressive relaxation exercises (PRE) as 1 day supervised and 3 days home based program in a week, for 6 weeks

Other: Progressive relaxation exercises

Control Group

NO INTERVENTION

Information was provided about pain and its treatment and the importance of relaxing exercises without any intervention, up to 6 weeks.

Interventions

Progressive relaxation exercises OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Florence Nightingale Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 24333009 BACKGROUND

• 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.

  PMID: 26211827 BACKGROUND

• 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.

  PMID: 16800971 BACKGROUND

• 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.

  PMID: 17898668 BACKGROUND

• 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.

  PMID: 16944295 BACKGROUND

• 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.

  PMID: 20967847 BACKGROUND

• 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.

  PMID: 19581224 BACKGROUND

Related Links

• incidence of breast cancer

MeSH Terms

Conditions

Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Vahit Özmen, Prof.

  Florence Nightingale Hospital, Istanbul

  STUDY CHAIR

• Gürsel Remzi Soybir, Prof.

  Memorial Etiler Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: October 25, 2019
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)