Fatigue
Conditions
Keywords
Breast cancer, Radiation therapy, Reflexology, Fatigue, Quality of life, Sleep disturbance
Brief summary
Oncologic patients often report increased fatigue during and after radiation therapy. Reflexology treatment has been demonstrated to alleviate symptoms of fatigue, nausea, and anxiety in oncologic patients treated with chemotherapy. The aim of the study is to evaluate the effect of reflexology on fatigue, quality of life, and quality of sleep of breast cancer patients during and after radiation therapy.
Detailed description
Reflexology (foot massage) is a complementary medicine technique which is performed by manual pressure on specific areas of the feet. Reflexology is based on a system of zones and reflex areas that are believed to reflect an image of the body on the feet with a premise that such work effects a physical change to the body. The effect of reflexology on fatigue, quality of life, and quality of sleep of 20 breast cancer patients during and after radiation therapy will be compared to age-matched control group of 20 breast cancer patients treated by radiation therapy.
Interventions
OTHERReflexology treatment.
Reflexology treatments (45 min. each) will be initiated at the beginning of radiation therapy, once a week, for 10 weeks.The treatment includes manual pressure on specific points of foot soles and massage of the calf area, adapted individually to each patient.
Sponsors
Tel Aviv University
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast cancer adult patients scheduled to receive adjuvant radiation therapy
Exclusion criteria
* Open wounds or evidence of metastases on the lower limbs * Touch therapy or other complementary therapy other than intervention procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Lee Fatigue Scale | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start | 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. |
| The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start | 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. |
Countries
Israel
Participant flow
Recruitment details
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
Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 25 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | personal reasons/ inconvenience | 13 | 5 |
Baseline characteristics
| Characteristic | Control Group | Reflexology Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 39 Participants | 61 Participants |
| Age, Continuous | 52.3 years STANDARD_DEVIATION 11.78 | 56 years STANDARD_DEVIATION 9.47 | 54.6 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Israel | 25 participants | 47 participants | 72 participants |
| Sex: Female, Male Female | 25 Participants | 47 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 25 |
| serious Total, serious adverse events | 0 / 47 | 0 / 25 |
Outcome results
Primary
The Lee Fatigue Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reflexology Group | The Lee Fatigue Scale | begining of the study | 3.71 units on a scale | Standard Deviation 1.76 |
| Reflexology Group | The Lee Fatigue Scale | 5 weeks | 3.9 units on a scale | Standard Deviation 1.57 |
| Reflexology Group | The Lee Fatigue Scale | 10 weeks | 3.6 units on a scale | Standard Deviation 1.45 |
| Control Group | The Lee Fatigue Scale | begining of the study | 3.68 units on a scale | Standard Deviation 1.56 |
| Control Group | The Lee Fatigue Scale | 5 weeks | 5.32 units on a scale | Standard Deviation 1.61 |
| Control Group | The Lee Fatigue Scale | 10 weeks | 4.52 units on a scale | Standard Deviation 2.05 |
Secondary
The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reflexology 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 |
| Reflexology Group | 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 |
| Reflexology Group | 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 |
| Control Group | The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) | beginning of study | 2.35 Scores on a scale | Standard Deviation 0.84 |
| Control Group | The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) | 5 weeks | 2.67 Scores on a scale | Standard Deviation 0.86 |
| Control Group | The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007) | 10 weeks | 2.49 Scores on a scale | Standard Deviation 0.87 |
Secondary
The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reflexology 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 |
| Reflexology Group | 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 |
| Reflexology Group | 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 |
| Control 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 | 4.09 Scores on a scale | Standard Deviation 1.13 |
| Control Group | The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007). | 5 weeks | 4.58 Scores on a scale | Standard Deviation 1.09 |
| Control Group | The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007). | 10 weeks | 4.49 Scores on a scale | Standard Deviation 1.02 |