Effects of Slow-Stroke Back Massage on CRF

NCT ID: NCT04545203

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2019-04-15

Brief Summary

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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

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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.

Conditions

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Chemotherapy-releated Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Slow-Stroke Back Massage Group

Group Type EXPERIMENTAL

Slow-stroke back massage

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Slow-stroke back massage

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Pinar Zorba Bahceli, PhD RN

Asistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Izmir Bakircay University Health Sciences Faculty

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017/62

Identifier Type: -

Identifier Source: org_study_id

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