Clinical trial NCT04826367: Relaxation Training by Tele-Rehabilitation in Patients With Breast Cancer
Official title: Relaxation Training By Tele-Rehabilitation Program In Patients With Breast Cancer Receiving Chemotherapy During COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Relaxation Therapy
Tele-Rehabilitation
Chemotherapy
Breast Cancer
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists randomly allocated exercise and control groups.
Primary purpose: SUPPORTIVE_CARE

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.

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 November 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 "pain" parameter provided from a reference article\[9\] similar to this study, The target sample size was determined with the aim of recruiting at least 20 participants per group, based on a power of 80% and a confidence interval of 95%, with an effect size of 0,91. With a possible 30% loss of patient to follow-up was added and totally, it was aimed to include 26 patients 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 The pain evaluation was identified as the primary outcome, while the fatigue, emotional state, quality of life, cognitive status, sleep quality and kinesiophobia were evaluated as secondary outcomes. Each patient was evaluated in the initial session prior to chemotherapy administration. A subsequent six-week intervention session was then conducted, with the same assessments repeated immediately following the intervention's completion.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: 24 hours
measure: 'Fatigue Impact Scale (FIS)
timeFrame: 1 week
measure: Hospital Anxiety and Depression (HAD)" scale
timeFrame: 1 week
measure: European Organization for Research and Treatment of Cancer- Quality of life (EORTC QLQ-C30) questionnaire
timeFrame: 1 week
measure: Functional Assessment of Chronic Illness Therapy-Cognitive Function (FACT-Cog)
timeFrame: 1 week
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 1 month
measure: Tampa Kinesophobia Scale (TKS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Florence Nightingale Hospital
Study officials:
affiliation: Demiroğlu Bilim University
name: Esat Namal, Asst. Prof.
role: STUDY_CHAIR
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