Relaxation Training by Tele-Rehabilitation in Patients With Breast Cancer

NCT04826367 | Completed DMC

• 1 other identifier: Tele-Relax
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

With developing treatment methods, oncological rehabilitation has become an important complementary part of cancer treatment. Due to the COVID-19 pandemic, the use of tele-rehabilitation has gained importance in terms of access to physical therapy in individuals with breast cancer. Considering the home environment and the patient profile, it is thought that relaxation exercises can be used in the most comfortable and safe way for patients to reduce the side effects of chemotherapy and can be used as home exercises whose effectiveness has been reported in the literature. The purpose of our study; to examine the effects of relaxation exercises performed by tele-rehabilitation on functional capacity, fatigue, emotional state, quality of life, cognitive status, sleep quality and kinesiophobia in breast cancer patients receiving chemotherapy. A total of 64 patients, will randomly be allocated to the exercise group (n = 32) and to the control group (n = 32). Participants will be evaluated at first appoinment and after 6 weeks of intervention. 'Brief Pain Questionnaire' for assessment of pain as assessment methods, 'Fatigue Impact Scale' for fatigue assessment, 'Hospital Anxiety-Depression Scale' for emotional state, 'EORTC QLQ-C30 Quality of Life Scale' for quality of life assessment, 'The FACT-Cog questionnaire' for cognitive state assessment, the' Pitsburg Sleep Quality Scale 'for the measurement of sleep quality, and the' Tampa Kinesophobia Scale 'for the assessment of kinesiophobia will be used.

Conditions

Breast Cancer

Keywords

Relaxation Therapy; Tele-Rehabilitation; Chemotherapy; Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• 'Fatigue Impact Scale (FIS)

  This scale, consisting of 40 items, evaluates the effects of fatigue on physical, cognitive, and psychosocial functions.Each item is rated on a five-step Likert scale, where 0 = no problems to 4 = extreme problems during the previous month. Ratings are summed to a total score, ranging from 0 to 160, and domain scores range from 0 to 40 for physical and cognitive functioning and 0-80 for the psychosocial functioning. Higher scores indicate greater limitations in functioning.

  1 week

• Hospital Anxiety and Depression (HAD)" scale

  It is a scale consisting of 14 questions and validity and reliability study has been done.\[15\] 7 of these questions evaluate anxiety, 7 evaluate depression in this Likert type measurement. The cut-off score for the anxiety subscale is 10/11 and for the depression subscale it is 7/8. Accordingly, those above these scores are considered at risk.

  1 week

• European Organization for Research and Treatment of Cancer- Quality of life (EORTC QLQ-C30) questionnaire

  It is used to measure the quality of life of individuals. The questionnaire has 3 subtitles and 30 questions: general health, functional score, and symptom score. The first 28 of the 30 items in the scale are a four-point Likert type scale and are scored as 1 (not at all) and 4 (very much) points. Questions 29 and 30 are the form of the domain of general well-being. Higher scores indicate better symptom severity for overall health and functional score, and worse for symptom score.

  1 week

• Functional Assessment of Chronic Illness Therapy-Cognitive Function (FACT-Cog)

  used to evaluate individuals' cognitive function. The questionnaire, consists of 37 items and 4 different subtitles, evaluates perceived cognitive skills, interpretations of other people, perceived cognitive disorders and quality of life. Individuals determine how valid a certain statement is for them in the last 7 days with a 5-point scale that includes scores between 0 (none) and 4 (very much). Higher scores indicate better cognitive functioning.

  1 week

• Pittsburg Sleep Quality Index (PSQI)

  consists of a total of 24 questions with 7 components.\[18\] These components; subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime dysfunction. If the total score obtained from these components is above 5, it indicates the "poor sleep" quality. For scores of 5 and below, sleep quality is considered 'good'.

  1 month

• Tampa Kinesophobia Scale (TKS)

  There are 17 questions in this scale, which was developed to measure the fear of motion / re-injury. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used in the scale. The total score is between 17-68. The high score the person gets on the scale indicates that his kinesiophobia is also high.

  1 month

Study Arms (2)

Exercise Group (EG)

EXPERIMENTAL

The participants in the EG will perform relaxation exercises in groups of up to 8 people, 3 days a week for 6 weeks via WhatsApp (© 2020 WhatsApp, Inc.) or Zoom (© 2012-2020 Zoom Video Communications, Inc.) applications. Relaxation exercises will be performed with the "Progressive Relaxation Exercises (PRE)" technique defined by Jacobson et al.\[11\] Tele-rehabilitation sessions will last approximately 40 minutes of each, accompanied by a physiotherapist who has 8 years of experience in the field of oncological rehabilitation.

Other: Telerehabilitation-based relaxation exercise group (EG)

Control Group (CG)

NO INTERVENTION

Participants in this group will have a brochure with simple exercises (relaxation exercises involving the upper and lower extremities) in sitting and lying positions. They will be advised to be as active as possible at home and to take mild walks at home. Any supervised exercise program will not apply to participants in the CG. If the participants apply any regular exercise program within 6 weeks, the participants in this group will be excluded from the study.

Interventions

Telerehabilitation-based relaxation exercise group (EG) OTHER

the participants in this group will perform the relaxation exercises thrice a week, for 6 weeks.

Exercise Group (EG)

Eligibility Criteria

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

You may qualify if:

• Karnofsky performance scale ≥90,
• Age between 18-65,
• Taxan class chemotherapy program has been planned,
• Not having regular exercise habits in the last 6 months,
• Patients who gave consent to voluntarily participate in the study.

You may not qualify if:

• Having a communication problem
• Standardized mini mental test score ≤23
• Previous chemotherapy treatments
• Having a neurological, rheumatological or orthopedic problem that prevents working,
• Presence of advanced lymphedema (Stage 3-4),
• Recurrence during treatment,
• Failing to use technology for tele-rehabilitation.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Florence Nightingale Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Related Publications (18)

• Brennan D, Tindall L, Theodoros D, Brown J, Campbell M, Christiana D, Smith D, Cason J, Lee A. A blueprint for telerehabilitation guidelines. Int J Telerehabil. 2010 Oct 27;2(2):31-4. doi: 10.5195/ijt.2010.6063. eCollection 2010 Fall.

  PMID: 25945175 BACKGROUND

• Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.

  PMID: 30946436 BACKGROUND

• Mata MD, Marzo MM, Teixidor P, Caceres C, Enseñat A, Boldó M, et al. Randomized controlled trial on the impact of cognitive telerehabilitation on cognition and quality of life in glioma patients. Annals of Physical and Rehabilitation Medicine. 2018;61:e271.

  BACKGROUND

• Piraux E, Caty G, Reychler G, Forget P, Deswysen Y. Feasibility and Preliminary Effectiveness of a Tele-Prehabilitation Program in Esophagogastric Cancer Patients. J Clin Med. 2020 Jul 9;9(7):2176. doi: 10.3390/jcm9072176.

  PMID: 32660126 BACKGROUND

• van der Kolk NM, de Vries NM, Kessels RPC, Joosten H, Zwinderman AH, Post B, Bloem BR. Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson's disease: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Nov;18(11):998-1008. doi: 10.1016/S1474-4422(19)30285-6. Epub 2019 Sep 11.

  PMID: 31521532 BACKGROUND

• Mella-Abarca W, Barraza-Sanchez V, Ramirez-Parada K. Telerehabilitation for people with breast cancer through the COVID-19 pandemic in Chile. Ecancermedicalscience. 2020 Aug 5;14:1085. doi: 10.3332/ecancer.2020.1085. eCollection 2020.

  PMID: 32863879 BACKGROUND

• Ariza-Garcia A, Lozano-Lozano M, Galiano-Castillo N, Postigo-Martin P, Arroyo-Morales M, Cantarero-Villanueva I. A Web-Based Exercise System (e-CuidateChemo) to Counter the Side Effects of Chemotherapy in Patients With Breast Cancer: Randomized Controlled Trial. J Med Internet Res. 2019 Jul 24;21(7):e14418. doi: 10.2196/14418.

  PMID: 31342907 BACKGROUND

• Galiano-Castillo N, Cantarero-Villanueva I, Fernandez-Lao C, Ariza-Garcia A, Diaz-Rodriguez L, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors. Cancer. 2016 Oct 15;122(20):3166-3174. doi: 10.1002/cncr.30172. Epub 2016 Jun 22.

  PMID: 27332968 BACKGROUND

• Jacobson, E. (1938). Progressive muscle relaxation. J Abnorm Psychol, 75(1), 18.

  BACKGROUND

• Dicle A, Karayurt O, Dirimese E. Validation of the Turkish version of the Brief Pain Inventory in surgery patients. Pain Manag Nurs. 2009 Jun;10(2):107-113.e2. doi: 10.1016/j.pmn.2008.08.002.

  PMID: 19481050 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Armutlu K, Keser I, Korkmaz N, Akbiyik DI, Sumbuloglu V, Guney Z, Karabudak R. Psychometric study of Turkish version of Fatigue Impact Scale in multiple sclerosis patients. J Neurol Sci. 2007 Apr 15;255(1-2):64-8. doi: 10.1016/j.jns.2007.01.073. Epub 2007 Mar 6.

  PMID: 17337007 BACKGROUND

• Aydemir O. Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg. 1997;8:187-280.

  BACKGROUND

• Guzelant A, Goksel T, Ozkok S, Tasbakan S, Aysan T, Bottomley A. The European Organization for Research and Treatment of Cancer QLQ-C30: an examination into the cultural validity and reliability of the Turkish version of the EORTC QLQ-C30. Eur J Cancer Care (Engl). 2004 May;13(2):135-44. doi: 10.1111/j.1365-2354.2003.00435.x.

  PMID: 15115469 BACKGROUND

• Atasavun Uysal S, Yildiz Kabak V, Karakas Y, Karabulut E, Erdan Kocamaz D, Keser I, Ozdemir K, Duger T. Investigation of the validity and reliability of the Turkish version of the Functional Assessment of Cancer Therapy-Cognitive Function in cancer patients. Palliat Support Care. 2022 Oct;20(5):694-700. doi: 10.1017/S147895152100136X.

  PMID: 34470680 BACKGROUND

• Agargun M. Pittsburgh uyku kalitesi indeksinin gecerligi ve guvenirligi. Turk Psikiyatri Dergisi. 1996;7:107-15.

  BACKGROUND

• Yilmaz ÖT, Yakut Y, Uygur F, ULUĞ N. Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon. 2011;22:44-9.

  BACKGROUND

• Scaturro D, Vitagliani F, Mangano MS, Tomasello S, Sconza C, Respizzi S, Vecchio M, Letizia Mauro G. Effect of Telerehabilitation and Outpatient Rehabilitation in Women with Breast Cancer. J Funct Morphol Kinesiol. 2023 Jul 27;8(3):105. doi: 10.3390/jfmk8030105.

  PMID: 37606400 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Esat Namal, Asst. Prof.

  Demiroğlu Bilim University

  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: The study consists randomly allocated exercise and control groups.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: January 20, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)