Back to resultsEffects of Slow-Stroke Back Massage on CRF
Primary Purpose
Chemotherapy-releated Fatigue
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Slow-stroke back massage
Sponsored by
About this trial
This is an interventional supportive care trial for Chemotherapy-releated Fatigue focused on measuring Chemotherapy-releated fatigue, Slow-stroke back massage, Nursing
Eligibility Criteria
Inclusion Criteria:
- 18 years and older women,
- Stages II or III breast cancer patients who had received at least 1 cycle of chemotherapy and were scheduled to receive 3 more cycles,
- Receiving one of the adriamycin-cyclophosphamide/cyclophosphamide-adriamycin-5-fluorouracil (AC/CAF) chemotherapy protocols,
Exclusion Criteria:
- With metastasis
- Having open wounds and edema on the upper limbs and back
- Using any complementary and alternative (CAM) treatment method to prevent fatigue during administration
Sites / Locations
- Izmir Bakircay University Health Sciences Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Slow-Stroke Back Massage Group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Brief Fatigue Inventory
The Brief Fatigue Inventory consisting of 10 items. First item evaluates whether patients with cancer experienced fatigue differently than usual in the previous week. Inventory includes items assessing general fatigue levels of patients (fatigue felt at the time of the interview, fatigue in general and the worst fatigue suffered in the past 24 hours) and the interference of fatigue with daily activities (general activity, mood, walking ability, work life, relationships with other people, the joy of life) in the past 24 hours. Scoring ranges between "0" and "10", "0" indicating no impact at all and "10" indicating the highest level of impact. Global Brief Fatigue Inventory score is calculated by taking the arithmetic mean of other 9 items. The total score to be obtained from the inventory is between 0 and 90. Çınar et al. performed the validity and reliability study of the Turkish version of Brief Fatigue Inventory and the internal consistency of the scale was determined to be 0.98.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04545203
Brief Title
Effects of Slow-Stroke Back Massage on CRF
Official Title
Effects of Slow-Stroke Back Massage on Chemotherapy-releated Fatigue in Breast Cancer Patients: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chemotherapy-related fatigue (CRF) is common in patients with breast cancer and it can be seen between 27% and 96% depending on the stage of cancer and treatment method. At the same time, CRF is reported as the most important symptom that reduces the functional capacity of patients with breast cancer and impairs their quality of life. For this reason, there is a need for an intervention that could decrease or prevent of CRF in breast cancer patients. In the literature, it is stated in the evidence-based guidelines that massage, which is one of the non-pharmacological methods, can be effective in CRF management.
Detailed Description
This an assessor-blinded,parallel group randomized controlled trial aimed that investigating the effect of slow-stroke back massage on CRF in breast cancer patients.This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received Adriamycin-Cyclophosphamide (AC)/ Cyclophosphamide-Adriamycin-5 Fluoro-uracil (CAF) regimens every 21 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-releated Fatigue
Keywords
Chemotherapy-releated fatigue, Slow-stroke back massage, Nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slow-Stroke Back Massage Group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Slow-stroke back massage
Intervention Description
Slow-stroke back massage was performed to the breast cancer patients in intervention group. The SSBM sessions were administered 10 minutes before and after chemotherapy treatment.The SSBM was applied for 20 minutes in total, on each cycle. The intervention group received 20-minute SSBM sessions 3 chemotherapy cycle in addition to the routine care.
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory
Description
The Brief Fatigue Inventory consisting of 10 items. First item evaluates whether patients with cancer experienced fatigue differently than usual in the previous week. Inventory includes items assessing general fatigue levels of patients (fatigue felt at the time of the interview, fatigue in general and the worst fatigue suffered in the past 24 hours) and the interference of fatigue with daily activities (general activity, mood, walking ability, work life, relationships with other people, the joy of life) in the past 24 hours. Scoring ranges between "0" and "10", "0" indicating no impact at all and "10" indicating the highest level of impact. Global Brief Fatigue Inventory score is calculated by taking the arithmetic mean of other 9 items. The total score to be obtained from the inventory is between 0 and 90. Çınar et al. performed the validity and reliability study of the Turkish version of Brief Fatigue Inventory and the internal consistency of the scale was determined to be 0.98.
Time Frame
It was filled before and after the 2nd, 3rd and 4th chemotherapy cycles (each cycle is 21 days). Changes in the Brief Fatigue Inventory scores were recorded before and after each three cycles.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older women,
Stages II or III breast cancer patients who had received at least 1 cycle of chemotherapy and were scheduled to receive 3 more cycles,
Receiving one of the adriamycin-cyclophosphamide/cyclophosphamide-adriamycin-5-fluorouracil (AC/CAF) chemotherapy protocols,
Exclusion Criteria:
With metastasis
Having open wounds and edema on the upper limbs and back
Using any complementary and alternative (CAM) treatment method to prevent fatigue during administration
Facility Information:
Facility Name
Izmir Bakircay University Health Sciences Faculty
City
Izmir
ZIP/Postal Code
35560
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Slow-Stroke Back Massage on CRF
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