Breast CancerNCT01577420
Reflexology: An Intervention for Advanced Breast Cancer
A study testing Reflexology Sessions in people with Breast Cancer, run by Michigan State University at 12 sites in United States.
Trial summary
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer within the context of conventional medical care. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reflexology Sessions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Stage III or IV breast cancer, or Stage I or II with Metastasis or Recurrence
- Able to perform basic ADLs
- Free of diagnosis of mental illness on chart
- Able to speak and understand English
- Access to a telephone
- Receiving chemotherapy at intake into the study
- Palliative Prognostic Score of 11 or lower
- Oriented to time, place, and person as determined by nurse recruiter
Who cannot join
- Receiving investigational new drug chemotherapy
- Receiving hospice care at intake
- Living in nursing home or similar facility
- Bedridden
- Undergoing bone marrow transplant
- Regularly using foot massage
- Regularly using reflexology
- Regularly using pedicure with foot massage
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Evanston Northwestern
Evanston, Illinois, 60201
Mt. Clemens
Evanston, Illinois, 60201
Hurley Medical Center
Flint, Michigan, 48503
GLCI/McLaren
Flint, Michigan, 48532
St. Joseph Mercy Oakland Hospital
Grand Rapids, Michigan, 44405
St. Mary's Health Care Center
Grand Rapids, Michigan, 49503
Great Lakes Cancer Institute (GLCI) MSU
Lansing, Michigan, 48910
Sparrow Hospital
Lansing, Michigan, 48912
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital-Troy Campus
Troy, Michigan, 48085
St. John Macomb
Warren, Michigan, 48093
Josephine Ford Cancer Care, Henry Ford Hospital
West Bloomfield, Michigan, 48323
About this study
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.
Read the detailed description
The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.
- Conditions
- Breast Cancer
- Being tested
- Reflexology Sessions, Placebo Sessions
- Keywords
- Reflexology, Breast Cancer, Complementary
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology SessionsOther
One session per week performed by certified reflexologist for four consecutive weeks.
Placebo SessionsOther
One session per week performed by research aide for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks. Receives: Other: Reflexology Sessions |
| Group B | Placebo comparator | Placebo Sessions: One session per week performed by research aide for four consecutive weeks. Receives: Other: Placebo Sessions |
| Group C | No intervention | Control; no foot sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
Measured: Baseline to week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startAug 2005
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Gwen Wyatt, Michigan State University
- Investigators
- Gwen Wyatt, PhD, RN, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577420
- Sponsor's protocol ID
- 5R01CA104883-05
- Other IDs
- 5R01CA104883-05
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
PubMed 19918155Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.
PubMed 21664296Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7.
PubMed 20467309Sikorskii A, Wyatt GK, Siddiqi AE, Tamkus D. Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial. Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 Feb 14.
PubMed 19620179
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflexology: An Intervention for Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01577420
- Acronym / sponsor ID
- 5R01CA104883-05
- Conditions
- Breast Cancer
- Keywords
- Reflexology, Breast Cancer, Complementary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.
Detailed description
The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Reflexology SessionsReflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks. |
| Group B | Placebo comparator | Other: Placebo SessionsPlacebo Sessions: One session per week performed by research aide for four consecutive weeks. |
| Group C | No intervention | –Control; no foot sessions |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Stage III or IV breast cancer, or Stage I or II with Metastasis or Recurrence
- Able to perform basic ADLs
- Free of diagnosis of mental illness on chart
- Able to speak and understand English
- Access to a telephone
Key exclusion criteria (8 listed)
- Receiving investigational new drug chemotherapy
- Receiving hospice care at intake
- Living in nursing home or similar facility
- Bedridden
- Undergoing bone marrow transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflexology SessionsOne session per week performed by certified reflexologist for four consecutive weeks. | Other | Group A |
| Placebo SessionsOne session per week performed by research aide for four consecutive weeks. | Other | Group B |
Primary outcome
Health Related Quality of Life
Time frame: Baseline to week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Background: PubMed 19918155Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009 Nov-Dec;58(6):444-51. doi: 10.1097/NNR.0b013e3181bf15fe.
- Background: PubMed 21664296Rahbar MH, Wyatt G, Sikorskii A, Victorson D, Ardjomand-Hessabi M. Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial. Contemp Clin Trials. 2011 Sep;32(5):620-9. doi: 10.1016/j.cct.2011.05.015. Epub 2011 Jun 2.
- Background: PubMed 20467309Wyatt G, Sikorskii A, Rahbar MH, Victorson D, Adams L. Intervention fidelity: aspects of complementary and alternative medicine research. Cancer Nurs. 2010 Sep-Oct;33(5):331-42. doi: 10.1097/NCC.0b013e3181d0b4b7.
- Results publication: PubMed 19620179Sikorskii A, Wyatt GK, Siddiqi AE, Tamkus D. Recruitment and early retention of women with advanced breast cancer in a complementary and alternative medicine trial. Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwen Wyatt, PhD, RN principal investigator
Michigan State University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology Sessions in people with Breast Cancer, run by Michigan State University at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (time frame: Baseline to week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.