NCT03415230

Brief Summary

This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

January 9, 2018

Last Update Submit

January 30, 2019

Conditions

Sleep DisturbanceAnxiety

Outcome Measures

Primary Outcomes (1)

  • Sleep Disturbances (insomnia)

    Athens insomnia scale (The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. It consists of eight items: the first five pertain to sleep induction, awakenings during the night, final awakening, total sleep duration, and sleep quality; while the last three refer to well-being, functioning capacity, and sleepiness during the day). Each item of the AIS can be rated 0-3, (with 0 corresponding to no problem at all and 3 to very serious problem); thus, the total score ranges from 0 (absence of any sleep-related problem) to 24 (the most severe degree of insomnia).

    Change from baseline total score at 4 weeks

Secondary Outcomes (1)

  • Anxiety

    Change from baseline total score at 4 weeks

Study Arms (2)

Therapeutic massage

EXPERIMENTAL

Women will undertake sessions of therapeutic massage

Other: Therapeutic massage

Sham massage

SHAM COMPARATOR

Women will undertake sessions of sham massage

Other: Sham massage

Interventions

Therapeutic massageOTHER

Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.

Therapeutic massage
Sham massageOTHER

Sham massage involves only light touch massage in a non systematic way

Sham massage

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with Breast Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women that completed their treatment
  • women experiencing insomnia
  • women experiencing anxiety
  • women that speak and understand Greek

You may not qualify if:

  • allergy to essential oils
  • use of anticoagulants
  • presence of edema
  • presence of Varicose veins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Centre

Nicosia, 2006, Cyprus

Location

MeSH Terms

Conditions

ParasomniasAnxiety Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Andreas Charalambous, PhD

    Cyprus University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
therapeutic massage vs sham massage
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 30, 2018

Study Start

April 1, 2018

Primary Completion

December 20, 2018

Study Completion

January 9, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

CY(1)