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Hand Massage on Fatigue With Cancer Receiving Brachytherapy

Primary Purpose

Hand Massage

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand Massage
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hand Massage focused on measuring Hand Massage, Fatigue, Brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18 years and over, underwent BT regularly Patients who volunteered to participate in the study Exclusion Criteria: Having skin problems with metastases, have bleeding or coagulation disorders, using complementary integrated therapy during the study, Having edema or wound in the hand area, not wanting to get a massage Patients receiving general anesthesia during the procedure

Sites / Locations

  • Dilek Efe Arslan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Interventions

Control Group

Arm Description

Hand massage should be done for 10 minutes, 5 minutes for each hand, before each brachytherapy (3 times in total in the 1st, 2nd and 3rd sessions).

The control group did not receive any intervention during the study period.

Outcomes

Primary Outcome Measures

Brief Fatigue Inventory (BFI)
The BFI, developed by Mendoza et al. (1999), was used to rapidly assess the severity and impact of cancer-related fatigue on daily living activities [33]. This inventory has nine items and measures fatigue severity (questions 1, 2, and 3) and fatigue interference in daily life activities (questions 4a, 4b, 4c, 4d, 4e, and 4f). Its reliability and validity, in the Turkish context, were determined by Usta Yeşilbalkan and Karadakovan (2005) and had a Cronbach's alpha value of Turkish version of 0.97 [34]. Each item of the BFI that consists of 9 items takes a value between 0-10 points.; higher scores indicate greater fatigue scores. Fatigue severity score is calculated by nine items and whereas fatigue interference score is calculated by summation of questions 4a, 4b, 4c, 4d, 4e, and 4f.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT06056713
Brief Title
Hand Massage on Fatigue With Cancer Receiving Brachytherapy
Official Title
The Effect of Hand Massage on Fatigue in Women With Cancer Receiving Brachytherapy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving BT therapy. Randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in Turkey. When 12 patients were included in each group, it was determined that the power was 90% at the 5% Type I error level, and a total of 24 women with gynecological cancer were included in the study. The primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. Patient Information Form and Brief Fatigue Inventory (BFI) used. This study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.
Detailed Description
Therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving BT therapy. . This randomized clinical trial was conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Massage
Keywords
Hand Massage, Fatigue, Brachytherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Interventions
Arm Type
Experimental
Arm Description
Hand massage should be done for 10 minutes, 5 minutes for each hand, before each brachytherapy (3 times in total in the 1st, 2nd and 3rd sessions).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group did not receive any intervention during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Hand Massage
Intervention Description
The hand massage application lasted 10 minutes, 5 minutes on each hand, before each brachytherapy (3 times in total in the 1st, 2nd and 3rd sessions).
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory (BFI)
Description
The BFI, developed by Mendoza et al. (1999), was used to rapidly assess the severity and impact of cancer-related fatigue on daily living activities [33]. This inventory has nine items and measures fatigue severity (questions 1, 2, and 3) and fatigue interference in daily life activities (questions 4a, 4b, 4c, 4d, 4e, and 4f). Its reliability and validity, in the Turkish context, were determined by Usta Yeşilbalkan and Karadakovan (2005) and had a Cronbach's alpha value of Turkish version of 0.97 [34]. Each item of the BFI that consists of 9 items takes a value between 0-10 points.; higher scores indicate greater fatigue scores. Fatigue severity score is calculated by nine items and whereas fatigue interference score is calculated by summation of questions 4a, 4b, 4c, 4d, 4e, and 4f.
Time Frame
The scale was filled in the baseline (after of the Hand massage).]

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study was conducted in women with gynecological cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and over, underwent BT regularly Patients who volunteered to participate in the study Exclusion Criteria: Having skin problems with metastases, have bleeding or coagulation disorders, using complementary integrated therapy during the study, Having edema or wound in the hand area, not wanting to get a massage Patients receiving general anesthesia during the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DİLEK EFE ARSLAN, PhD
Organizational Affiliation
ERCİYES UNİVERSİTY
Official's Role
Study Director
Facility Information:
Facility Name
Dilek Efe Arslan
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38280
Country
Turkey

12. IPD Sharing Statement

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Hand Massage on Fatigue With Cancer Receiving Brachytherapy

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