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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Reflexology treatment.

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Breast cancer, Radiation therapy, Reflexology, Fatigue, Quality of life, Sleep disturbance

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Sheba Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

NCT ID

NCT00825682

First Posted

January 19, 2009

Last Updated

October 16, 2016

Sponsor

Sheba Medical Center

Collaborators

Tel Aviv University

1. Study Identification

Unique Protocol Identification Number

NCT00825682

Brief Title

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

Official Title

The Effect of Reflexology on Radiation-related Fatigue and QOL in Breast Cancer Patients: a Pilot Study.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

Collaborators

Tel Aviv University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

Breast cancer, Radiation therapy, Reflexology, Fatigue, Quality of life, Sleep disturbance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

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.

Arm Title

2

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Reflexology treatment.

Other Intervention Name(s)

Foot massage

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Lee Fatigue Scale

Description

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

Secondary Outcome Measure Information:

Title

The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).

Description

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

Title

The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorit D Gamus, MD, PhD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Hospital,

City

Ramat Gan

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

15524070

Citation

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.

Results Reference

background

PubMed Identifier

15684846

Citation

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.

Results Reference

background

PubMed Identifier

15778569

Citation

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.

Results Reference

background

PubMed Identifier

15336336

Citation

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.

Results Reference

background

PubMed Identifier

16487421

Citation

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.

Results Reference

background

Fatigue

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial