Trial Outcomes & Findings for The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients (NCT NCT00825682)

Results Overview

The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue. The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Results posted on

2016-12-08

Participant Flow

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.

Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	47	25
Overall Study COMPLETED	34	20
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study personal reasons/ inconvenience	13	5

Baseline Characteristics

The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reflexology Group n=47 Participants 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 n=25 Participants 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 n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	22 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 9.47 • n=5 Participants	52.3 years STANDARD_DEVIATION 11.78 • n=7 Participants	54.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	25 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Israel	47 participants n=5 Participants	25 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Population: The final analysis included 33 women in the experimental group and 20 in the control group.

The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue. The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients.

Outcome measures

Outcome measures
Measure	Reflexology Group n=33 Participants 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 n=20 Participants 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.
The Lee Fatigue Scale begining of the study	3.71 units on a scale Standard Deviation 1.76	3.68 units on a scale Standard Deviation 1.56
The Lee Fatigue Scale 5 weeks	3.9 units on a scale Standard Deviation 1.57	5.32 units on a scale Standard Deviation 1.61
The Lee Fatigue Scale 10 weeks	3.6 units on a scale Standard Deviation 1.45	4.52 units on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Population: The final ananlysis included 34 women in the experimental group, and 20 women in the control group.

The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc. A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Reflexology Group n=34 Participants 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 n=20 Participants 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.
The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007). beginning of study	4.23 Scores on a scale Standard Deviation 1.36	4.09 Scores on a scale Standard Deviation 1.13
The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007). 5 weeks	4.17 Scores on a scale Standard Deviation 1.25	4.58 Scores on a scale Standard Deviation 1.09
The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007). 10 weeks	4.04 Scores on a scale Standard Deviation 1.25	4.49 Scores on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Population: The final analysis included 34 women in the experimental group and 20 in the control group.

examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills. A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Reflexology Group n=34 Participants 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 n=20 Participants 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.
The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) beginning of study	2.51 Scores on a scale Standard Deviation 1.02	2.35 Scores on a scale Standard Deviation 0.84
The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) 5 weeks	2.27 Scores on a scale Standard Deviation 0.67	2.67 Scores on a scale Standard Deviation 0.86
The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) 10 weeks	2.19 Scores on a scale Standard Deviation 0.73	2.49 Scores on a scale Standard Deviation 0.87

Adverse Events

Reflexology Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Dorit Gamus

Sheba Medical Center

Phone: +972-3-5303956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place