Foot Bath and Chemotherapy Induced Fatigue

NCT04663178 | Completed

• 1 other identifier: Warm Salt Water Foot Bath
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In a limited number of studies conducted with the participation of cancer patients, it has been reported that warm water bath may be beneficial for management of cancer-related fatigue. Objective: This experimental study was conducted to evaluate the effect of warm salt water foot bath applied to reduce the chemotherapy-induced fatigue. Interventions/Methods: Seventy-nine patients who were experiencing moderate or higher level of fatigue were included in this study conducted between November 2017-February 2018. 42 of the patients were assigned to the experimental group and 37 patients were assigned to the control group. A training booklet about chemotherapy-induced fatigue were given to all patients. In addition, the experimental group was asked to perform 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath. Subsequently, the patients were called by phone every day for one week to record their fatigue levels. Results: The 7-day fatigue course of both groups was similar. However the physical, emotional, affective and cognitive distress related to fatigue decreased in the experimental group but did not decrease in the control group. Conclusion: The warm salt water footbath may be an effective approach in enhancing fatigue related quality of life. However, it is needed to conduct more comprehensive studies to express the effectiveness. Implications to Practice: Nurses can propose the use of the warm salt water footbath in the management of chemotherapy induced fatigue. Keywords: Chemotherapy Induced Fatigue, Warm salt water foot bath

Conditions

Chemotherapeutic Toxicity; Chemotherapy-induced Fatigue

Keywords

Chemotherapy Induced Fatigue; Warm salt water foot bath

Outcome Measures

Primary Outcomes (3)

• Patient Identification Form

  This form, which was prepared by the researcher in accordance with the literature and consisting of seven sections, contains 29 questions evaluating the personal characteristics of the patients, the characteristics of the disease and the treatment process, and the functional adequacy of the patient.

  One week

• Fatigue Severity

  The severity of fatigue was classified depending on NCI-CTCAE v3.0 adverse events classification system for fatigue: "0" for "I am not tired", "1" for "I am slightly tired, relieved by rest"; "2" for "I am moderately tired, not relieved by rest"; "3" for "I am very tired, not relieved by rest and is limited instrumental activities of daily living", "4" for "I am extremely tired", fatigue is not relieved by rest and is limited self-care activities of daily living.

  One week

• Piper Fatigue Scale

  The questions the fatigue-related behavioural, affective, sensory and cognitive distress level of the patients in 22 items and 4 subscales. In each item of the scale, emotions that may be felt due to fatigue are ranged from 1 (weak) to 10 (strong). The person defines his/her fatigue he/she experiences at that moment by marking the best answer (number) reflecting it. Fatigue-related subscale scores (behavioural, affective, sensory and cognitive) are obtained by summing the scores of all items in that subscale and dividing the resulting score to number of items. The overall fatigue score is obtained by summing the score of all items and dividing them by the total number of items. The subscale and general scale score ranges from 0 to 10 and the increased score indicates increased perceived fatigue. There are also 5 open-ended questions in the scale and these questions are not included in the score calculation of fatigue perception.

  One week

Study Arms (2)

Warm Salt Water Foot Bath Group

EXPERIMENTAL

In the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale (PFS) were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to patients. Each patient received iodine salt and a liquid thermometer to measure the temperature of the water. The patients were asked 1 day after the treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes for 7 days. Subsequently, the fatigue level of the patients was evaluated 30 minutes after having a warm saltwater foot bath and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. In the last interview PFS was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed.

Other: Warm Salt Water Foot Bath

Control Group

NO INTERVENTION

A training booklet about chemotherapy-induced fatigue In the first interview Patient Identification Form, Fatigue Severity and Piper Fatigue Scale were applied to the patients. A training booklet about chemotherapy-induced fatigue containing the definition, causes, ad development process of chemotherapy-induced fatigue and effective coping approaches were delivered to experimental group. Subsequently, the fatigue level of the patients was evaluated and recorded by questioning via calling them with phone every day and using the Visual Fatigue Scale for 7 days. The patients were evaluated in the evening. In the last interview conducted with the patient on the 7th day, Piper's Fatigue Scale was used to evaluate the effect level of fatigue on the quality of life and the assessment process was completed.

Interventions

Warm Salt Water Foot Bath OTHER

A training booklet about chemotherapy-induced fatigue + 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath.

Warm Salt Water Foot Bath Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving adjuvant or neoadjuvant chemotherapy with the diagnosis of early stage cancer
• Having fatigue severity of 3 and \>3
• Agreeing to participate in the study.

You may not qualify if:

• Having the complaint of peripheral neuropathy.
• Being diagnosed with diabetes
• Having impaired skin integrity.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Outpatient Chemotherapy Unit of the Institute of Oncology in Istanbul University

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

Study Officials

• Ferda AKYUZ OZDEMIR

  IUC Florence Nıghtingale Nursing Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effect of Warm Salt Water Foot Bath on the Management of Chemotherapy Induced Fatigue

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 10, 2020
• Study Start: November 15, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)