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Trial record 1 of 1 for:    15778569 [PUBMED-IDS]
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The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00825682
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dorit Gamus, Sheba Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fatigue
Intervention: Other: Reflexology treatment.

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study included 72 breast cancer patients, scheduled for complementary radiation therapy at the Cancer Center at Tel Hashomer Hospital during the years 2008-2011. Participants were recruited to the experimental and control groups, on a voluntary basis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.

Reporting Groups
  Description
Reflexology Group The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
Control Group The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.

Participant Flow:   Overall Study
    Reflexology Group   Control Group
STARTED   47   25 
COMPLETED   34   20 
NOT COMPLETED   13   5 
personal reasons/ inconvenience                13                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Reflexology Group The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
Control Group The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
Total Total of all reporting groups

Baseline Measures
   Reflexology Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   25   72 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   39   22   61 
>=65 years   8   3   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (9.47)   52.3  (11.78)   54.6  (10.4) 
Gender 
[Units: Participants]
     
Female   47   25   72 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Israel   47   25   72 


  Outcome Measures

1.  Primary:   The Lee Fatigue Scale   [ Time Frame: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start ]

2.  Secondary:   The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).   [ Time Frame: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start ]

3.  Secondary:   The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)   [ Time Frame: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a pilot non-randomized controlled study, with a relatively small sample and a single therapist.The control group received no additional intervention.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Dorit Gamus
Organization: Sheba Medical Center
phone: +972-3-5303956
e-mail: dorit.gamus@sheba.health.gov.il


Publications:

Responsible Party: Dorit Gamus, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00825682     History of Changes
Other Study ID Numbers: SHEBA-07-4923-DG-CTIL
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: July 3, 2012
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016