NCT06056713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 21, 2023

Last Update Submit

September 21, 2023

Conditions

Hand Massage

Keywords

Hand MassageFatigueBrachytherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    The scale was filled in the baseline (after of the Hand massage).]

Study Arms (2)

Experimental Interventions

EXPERIMENTAL

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).

Behavioral: Hand Massage

Control Group

NO INTERVENTION

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

Interventions

Hand MassageBEHAVIORAL

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).

Experimental Interventions

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was conducted in women with gynecological cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and over,
  • underwent BT regularly
  • Patients who volunteered to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Efe Arslan

Kayseri, Melikgazi, 38280, Turkey (Türkiye)

Location

Related Publications (1)

  • Efe Arslan D, Kilic Akca N, Aslan D. The effect of hand massage on fatigue in women with cancer receiving brachytherapy: randomized clinical trial. Support Care Cancer. 2024 Dec 3;33(1):2. doi: 10.1007/s00520-024-09059-0.

    PMID: 39625640DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • DİLEK EFE ARSLAN, PhD

    ERCİYES UNİVERSİTY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ErciyesU

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

September 30, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

TU(1)