Factors Affecting Functionality in Breast Cancer Survivors

NCT04245657 | Completed DMC

• 1 other identifier: BakircayU
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.

Conditions

Breast Cancer; Breast Cancer Female; Breast Cancer Lymphedema; Breast Carcinoma in Situ; Hand Grasp; Pain, Shoulder

Keywords

Breast Cancer; Lymphedema; Upper Extremity Function; Hand Grip Strength

Outcome Measures

Primary Outcomes (1)

• Hand-Grip Strength

  Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.

  15 minutes

Secondary Outcomes (7)

• Tissue Dielectric Constant Measurement:

  30 minutes

• Muscle strength

  10 minutes

• Pain Threshold Measurement

  8 minutes

• International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  3 minutes

• Fatigue Impact Scale

  3 minutes

Study Arms (1)

Breast Cancer Survivors

Female breast cancer survivors who underwent unilateral breast cancer surgery ( total or conservative) and completed their adjuvant therapies such as chemotherapy and radiotherapy prior to participation in this study.

Other: Tissue Dielectric Constant Measurement; Other: Muscle strength measurement; Other: Hand-Grip Strength Measurement; Other: Pain Threshold Measurement; Other: International Physical Activity Questionnaire-Short Form (IPAQ-SF); Other: Fatigue Impact Scale; Other: Disabilities of Arm, Shoulder and Hand Scale (DASH); Other: Exercise Benefits/ Barriers Scale; Other: Beck Depression Scale

Interventions

Tissue Dielectric Constant Measurement OTHER

Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system. This device mainly aims to assess the dielectric constant of tissues which is related to the amount of tissue water. In the case of pre-lymphedema or lymphedema, one can assess objectively regarding sub-tissue fluid changes via this device. Triplicate measurements will be taken for each reference point.

Breast Cancer Survivors

Muscle strength measurement OTHER

Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded.

Breast Cancer Survivors

Hand-Grip Strength Measurement OTHER

Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.

Breast Cancer Survivors

Pain Threshold Measurement OTHER

The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace.

Breast Cancer Survivors

International Physical Activity Questionnaire-Short Form (IPAQ-SF) OTHER

This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.

Breast Cancer Survivors

Fatigue Impact Scale OTHER

This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less.

Breast Cancer Survivors

Disabilities of Arm, Shoulder and Hand Scale (DASH) OTHER

DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function.

Breast Cancer Survivors

Exercise Benefits/ Barriers Scale OTHER

Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.

Breast Cancer Survivors

Beck Depression Scale OTHER

Beck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level.

Breast Cancer Survivors

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Being a woman and having the right or left unilateral breast cancer surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female Breast cancer survivors aged 25-65 years old who had unilateral breast cancer surgery will be enrolled to this study.

You may qualify if:

• Being aged between 25 and 65 years old
• Having the ability to read and write in the Turkish language
• Having unilateral (right or left) breast cancer surgery history
• Being a woman
• Finished adjuvant therapies such as chemotherapy and radiotherapy prior to participation

You may not qualify if:

• Active infection
• Active/recurrent malignity
• Having orthopedic and/or neurological defect
• Having an advanced postural deficiency
• Having nerve injury (Ulnar, median, radial nerve)
• Having a loss of sensory
• Bilateral (both side) breast cancer surgery
• Having mental and cognitive problems which can interfere to participate
• Serious range of movement restriction in shoulder, elbow and/or wrist joints
• Having Carpal Tunnel Syndrome
• Having reflex denervation and abnormal neural findings

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

İzmir Çiğli State Training Hospital

Izmir, Çiğli, 35620, Turkey (Türkiye)

Location

Related Publications (19)

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• Galiano-Castillo N, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, Menjon-Beltran S, Arroyo-Morales M. Altered pattern of cervical muscle activation during performance of a functional upper limb task in breast cancer survivors. Am J Phys Med Rehabil. 2011 May;90(5):349-55. doi: 10.1097/PHM.0b013e318214e406.

  PMID: 21765253 BACKGROUND

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  PMID: 25684491 BACKGROUND

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  PMID: 25099463 BACKGROUND

• Tugral A, Bakar Y, Akyol M. Predictors of Upper Extremity Function in Breast Cancer Survivors. Physiother Res Int. 2025 Jul;30(3):e70082. doi: 10.1002/pri.70082.

  PMID: 40543072 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema; Breast Carcinoma In Situ; Shoulder Pain; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yeşim Bakar, Professor

  Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehab

  STUDY DIRECTOR

• İlker Kızıloğlu, MD

  İzmir Çiğli State Training Hospital, Department of General Surgery

  PRINCIPAL INVESTIGATOR

• Alper Tuğral, PT

  Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alper Tuğral, PT, MSc, Lecturer. Izmir Bakircay University Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: December 17, 2019
• Primary Completion: September 26, 2021
• Study Completion: September 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)