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| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 20 breast cancer patients scheduled for adjunctive radiation treatment will be recruited for this study to receive reflexology treatment initiated at the beginning of radiation therapy, once a week, for 10 weeks. |
|
| 2 | No Intervention | 20 breast cancer patients, scheduled for adjunctive radiation treatment, matched by age to the intervention group will receive treatment as usual, and will be evaluated by the same measures as the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology treatment. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorit D Gamus, MD, PhD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Hospital, | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15524070 | Background | Deng G, Cassileth BR, Yeung KS. Complementary therapies for cancer-related symptoms. J Support Oncol. 2004 Sep-Oct;2(5):419-26; discussion 427-9. | |
| 15684846 | Background | Kohara H, Miyauchi T, Suehiro Y, Ueoka H, Takeyama H, Morita T. Combined modality treatment of aromatherapy, footsoak, and reflexology relieves fatigue in patients with cancer. J Palliat Med. 2004 Dec;7(6):791-6. doi: 10.1089/jpm.2004.7.791. |
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Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The final analysis included 33 women in the experimental group and 20 in the control group. | Posted | Mean | Standard Deviation | units on a scale | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
|
10 weeks
no adverse effects were reported during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a pilot non-randomized controlled study, with a relatively small sample and a single therapist.The control group received no additional intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dorit Gamus | Sheba Medical Center | +972-3-5303956 | dorit.gamus@sheba.health.gov.il |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D001943 | Breast Neoplasms |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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| Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
| 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. | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
| 15778569 | Background | Yang JH. [The effects of foot reflexology on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy]. Taehan Kanho Hakhoe Chi. 2005 Feb;35(1):177-85. doi: 10.4040/jkan.2005.35.1.177. Korean. |
| 15336336 | Background | Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016. |
| 16487421 | Background | Quattrin R, Zanini A, Buchini S, Turello D, Annunziata MA, Vidotti C, Colombatti A, Brusaferro S. Use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment: methodology and outcomes. J Nurs Manag. 2006 Mar;14(2):96-105. doi: 10.1111/j.1365-2934.2006.00557.x. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| 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. |
| OG001 | 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. |
|
|
| 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. | The final ananlysis included 34 women in the experimental group, and 20 women in the control group. | Posted | Mean | Standard Deviation | Scores on a scale | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
|
|
|
| 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. | The final analysis included 34 women in the experimental group and 20 in the control group. | Posted | Mean | Standard Deviation | Scores on a scale | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | 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. | 0 | 25 | 0 | 25 |
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| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| 10 weeks |
|
| 10 weeks |
|