Relaxation Training by Tele-Rehabilitation in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      The study is planned as a single center, single-blind (assessment), randomized and home-based
      tele-rehabilitation intervention. The study will be conducted at Gayrettepe Florence
      Nightingale Hospital between January 2021 and March 2022. Participants will consist of
      individuals with breast cancer undergoing a routine taxane chemotherapy program. The
      participants will randomly be assigned to study (telerehabilitation-based relaxation
      exercises) and control groups.

      Participants who will meet criteria's will be informed by the medical oncologist involved in
      the study in the medical oncology clinic in hospital and an informed consent form will be
      provided to the volunteers who want to participate in the study. After approval of the
      consent form, participants will be randomly divided into two groups. To provide randomization
      at a 1:1 sharing ratio, 2 blocks will be created with the "block randomization" method,
      computer-generated numbers will be put in sealed envelopes. The number from the envelope
      selected by the patients will indicate which block will be. Randomizations will be made by a
      non-study researcher. The assessor will also be blind to allocations of the groups.
      Demographic information of the participants will be recorded and pain, fatigue, emotional
      state, quality of life, cognitive status, sleep quality and kinesiophobia will be evaluated.

      In order to calculate the sample size, power analysis (80% power and 5% type 1 error) was
      performed with the standard deviation and confidence interval data of the "6 minutes walking
      test" parameter provided from a reference article [9] similar to our study, and a possible
      30% loss of patient follow-up was added. It was aimed to include a total of 64 patients,
      including 32 individuals in each group.

      Assessments will be made at baseline and after 6 weeks of intervention. In case of
      significant results, exercise programs will be provided to the participants who cannot take
      the relevant exercises in the control group.

      Interventions Telerehabilitation-based relaxation exercise group (EG)

      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. The
      expected relaxations of the hand, elbow, shoulder, hip, knee, ankle, and facial muscles will
      be executed by PRE performed throughout the course of the session. Each exercise will be
      conducted as 5 seconds of contraction and 10 seconds of relaxation. Breathing techniques will
      occasionally be performed between exercises, so that the effectiveness of relaxation will be
      increased. The work area will be desired to be well ventilated and an environment where
      individuals are comfortable. Individuals will be asked to take a long sitting position in
      comfortable seats. Then, the following instructions will be given to the patients in order:

        -  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. Necessary recommendations for the absence of
           any factors that create stress during exercise will be given. Patients who miss 10% of
           the therapy sessions will be excluded from the study.

      Control Group (CG) 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.

      Outcomes Pain assessment: "Brief Pain Inventory (BPİ)" will be used for pain assessment. It
      is a 9-question scale that evaluates the location and severity of pain, especially with the
      last 24-hour activities. A validity and reliability study has been performed for the short
      pain inventory, which is commonly used in cancer patients.[12, 13] Scores between 3-4 are
      defined as mild pain, between 5-7 as moderate, and between 8-10 as severe pain.

      Fatigue assessment: It will be measured with the 'Fatigue Impact Scale (FIS)'. This scale,
      consisting of 40 items, evaluates the effects of fatigue on physical, cognitive, and
      psychosocial functions. Higher scores indicate greater exposure to fatigue. Validity and
      reliability study has been conducted.[14] Emotional state assessment: It will be measured by
      the "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.

      Quality of life assessment: European Organization for Research and Treatment of Cancer-
      Quality of life (EORTC QLQ-C30) questionnaire will be 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. The validation and
      reliability of the questionnaire was conducted.[16] Cognitive state assessment: Functional
      Assessment of Chronic Illness Therapy-Cognitive Function (FACT-Cog) will be 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. Validity and reliability
      study of the questionnaire has been done.[17] Sleep quality: will be measured with the
      Pittsburg Sleep Quality Index (PSQI). This scale, validity and reliability have been studied,
      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'.

      Kinesiophobia evaluation: It will be evaluated with the "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. The validity and reliability study has been
      done.[19]

      Statistical Analysis SPSS version 26.0 (Copyright © IBM Corporation and its licencors 1989,
      2019) program will be used for statistical evaluation. A descriptive analysis will be
      performed and the mean, 95% confidence interval and standard deviations (SDs) will be
      calculated for each group. Initially, Student's t test and Chi-square test will be used to
      check for differences between groups. Normal distribution of variables will be analyzed by
      Shapiro-Wilk test. Intervention effects on study variables will be tested using the repeated
      measure ANCOVA. If a significant interaction occurs in the analysis, paired comparisons will
      be made with the Bonferroni test to determine whether there is a difference in scores between
      groups. Also, the effect size will be calculated using Cohen's d values. P<0.05 will be
      considered significant.

      Anticipated Results:

        1. Observing positive effects of relaxation exercises with tele-rehabilitation on pain,
           fatigue, emotional state, quality of life, cognitive status, sleep quality and
           kinesophobia in individuals with breast cancer who received chemotherapy during Covid-19
           period.

        2. To increase the applicability of tele-rehabilitation,

        3. Continuation patients' access to physical therapy during the Covid-19 period.
    

Intervention name(s): Telerehabilitation-based relaxation exercise group (EG)
Intervention type(s): Other
Intervention description(s): the participants in this group will perform the relaxation exercises thrice a week, for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists randomly allocated exercise and control groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Relaxation Therapy; Tele-Rehabilitation; Chemotherapy; Breast Cancer