Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

A study testing Reflexology in people with Breast Cancer, run by Michigan State University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or… 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 9 sitesUnited States
Study dates: 17 Apr 2012to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age ≥ 21
Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence
Able to perform basic ADLs
Undergoing chemotherapy and/or hormonal therapy for breast cancer
Able to speak and understand English
Have access to a telephone
Able to hear normal conversation
Cognitively oriented to time, place, and person (determined via nurse recruiter)

Who cannot join

Diagnosis of major mental illness on the medical record and verified by the recruiter
Residing in a nursing home
Bedridden
Currently receiving regular reflexology
Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Northwestern
Chicago, Illinois, 49201
Hurley Medical Center
Flint, Michigan, 48503
Lemmon-Holton Cancer Center
Grand Rapids, Michigan, 49503
Breslin Cancer Center
Lansing, Michigan, 48910
Sparrow Cancer Center
Lansing, Michigan, 48912
McLaren Macomb
Mount Clemens, Michigan, 48043
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48241
Beaumont Hospital
Royal Oak, Michigan, 48073
St. Johns Providence
Warren, Michigan, 48093

Other trials in United States

About this study

Read the detailed description

This project tests the benefits of a home-based intervention of foot reflexology for improving health-related quality of life (HRQOL) including symptom responses, functioning, and health perceptions in women treated with chemotherapy for advanced breast cancer. Reflexology applies a firm walking-motion during sessions and is based on the premise that the foot has reflexes mirroring organs of the body. Symptom burden is the strongest predictor of HRQOL for cancer patients. This project brings together expertise from nursing, reflexology, communication, statistics, and health economics. The primary specific aims, in a sample of women with advanced breast cancer receiving chemotherapy, are to determine the effects of a 4-week, home-based reflexology intervention delivered by a friend/family provider compared to attention control for improvement of:

HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11. The investigators hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11.
Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time. The investigators hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group.
Symptom-related use of unscheduled health services during the 11-week study. The investigators hypothesize that fewer unscheduled services will be used for symptom management over the 11-week study period by women receiving reflexology compared to women in the attention control.

The exploratory aims are to: 1) Explore differences between trial arms in perceptions of social support due to the family- or friend-delivered reflexology sessions at study weeks 5 and 11; 2) Determine if effects of the reflexology intervention on HRQOL are mediated by social support; and 3) Use the newly developed NIH PROMIS standardized symptom and functioning instruments to assess the effects of the reflexology intervention and to compare the responsiveness of PROMIS instruments and existing instruments designed to measure similar constructs.

This project has immense potential to make an effective symptom management intervention accessible to patients in their homes via a friend or family home provider. The investigators will not only intervene to enhance HRQOL but also to evaluate social support and costs associated with unscheduled health services. Effective symptom management provides time and cost savings to clinicians, advances the current state-of-the-science, and promotes adherence to medical treatment that may ultimately enhance survival.

Conditions: Breast Cancer
Being tested: Reflexology
Keywords: Breast Cancer, Reflexology, 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.

ReflexologyOther
Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient

Study groups in NCT01582971
Study group	Role	What they receive
Intervention	Experimental	Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member Receives: Other: Reflexology
Control	No intervention	Standard medical care: no reflexology

What is being measured

The primary outcome is the main question the study is designed to answer.

The M.D. Anderson Symptom Inventory (MDASI)
The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.
Higher symptom severity and interference scores represent worse outcome.
Measured: Week 5 and week 11
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
1. PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.
2. PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.
Higher scores representing better outcomes in each subscale.
Measured: Week 5 and week 11
Quality of Life Index (QLI)
The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.
Measured: Week 5 and week 11
Use of Unscheduled Health Service
Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.
Measured: Week 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 2012May 2016

First posted23 Apr 2012 (estimated)
Study start17 Apr 2012
Primary completion1 May 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01582971
Sponsor's protocol ID: 1R01CA157459-01
Other IDs: 1R01CA157459-01
Status last verified: Mar 2018
First submitted: 17 Apr 2012
Last updated: 18 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Sikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2.
PubMed 31267277
Luo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14.
PubMed 30552595

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home-Based Symptom Management Via Reflexology for Breast Cancer Patients
ClinicalTrials.gov ID: NCT01582971
Acronym / sponsor ID: 1R01CA157459-01
Conditions: Breast Cancer
Keywords: Breast Cancer, Reflexology, Complementary
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 17 Apr 2012
Primary completion: 1 May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 23 Apr 2012 (estimated)
Results: Posted 2 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11. The investigators hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11.
Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time. The investigators hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group.
Symptom-related use of unscheduled health services during the 11-week study. The investigators hypothesize that fewer unscheduled services will be used for symptom management over the 11-week study period by women receiving reflexology compared to women in the attention control.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: ReflexologyReflexology: 4 weekly foot reflexology sessions delivered by friend/family member
Control	No intervention	–Standard medical care: no reflexology

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)

Age ≥ 21
Diagnosis of breast cancer, Stage III, IV, or Stage I or II with metastasis or recurrence
Able to perform basic ADLs
Undergoing chemotherapy and/or hormonal therapy for breast cancer
Able to speak and understand English

Key exclusion criteria (5 listed)

Diagnosis of major mental illness on the medical record and verified by the recruiter
Residing in a nursing home
Bedridden
Currently receiving regular reflexology
Diagnosis of symptoms of deep vein thrombosis or painful foot neuropathy, which will require medical approval

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
ReflexologyFriend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient	Other	Intervention

Primary outcome

The M.D. Anderson Symptom Inventory (MDASI)
Time frame: Week 5 and week 11
The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived. Higher symptom severity and interference scores represent worse outcome.
Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0
Time frame: Week 5 and week 11
1. PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population. 2. PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population. Higher scores representing better outcomes in each subscale.
Quality of Life Index (QLI)
Time frame: Week 5 and week 11
The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.
Use of Unscheduled Health Service
Time frame: Week 11
Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.

Results and safety

Results posted to the registry on 2 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	128	89
Control	128	91

Primary outcome: The M.D. Anderson Symptom Inventory (MDASI)

Time frame: Week 5 and week 11. Least squares mean (Standard Error). Unit: units on a scale

Measure	Week 5 Intervention Group n = 89	Week 5 Control Group n = 91	Week 11 Intervention Group n = 89	Week 11 Control Group n = 91
MDASI summed symptom severity	23.55 (1.52)	29.69 (1.48)	26.28 (1.54)	28.67 (1.52)
MDASI summed symptom interference	11.19 (1.16)	16.04 (1.12)	12.43 (1.17)	14.88 (1.16)

Population analysed: Patient outcome data collected at week 5 and week 11

Primary outcome: Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0

Time frame: Week 5 and week 11. Least squares mean (Standard Error). Unit: units on a scale

Measure	Week 5 Intervention Group n = 89	Week 5 Control Group n = 91	Week 11 Intervention Group n = 89	Week 11 Control Group n = 91
PROMIS-Physical function subscale	42.06 (0.57)	41.81 (0.55)	42.93 (0.57)	42.80 (0.56)
PROMIS-Social role subscale	47.59 (0.78)	46.86 (0.75)	48.58 (0.79)	45.92 (0.78)

Population analysed: Participant outcome data collected at week 5 and week 11

Primary outcome: Quality of Life Index (QLI)

Time frame: Week 5 and week 11. Least squares mean (Standard Error). Unit: units on a scale

Measure	Week 5 Intervention Group n = 89	Week 5 Control Group n = 91	Week 11 Intervention Group n = 89	Week 11 Control Group n = 91
Value	22.53 (0.29)	21.94 (0.28)	22.69 (0.29)	22.08 (0.29)

Population analysed: Participant outcome data collected at week 5 and week 11

Primary outcome: Use of Unscheduled Health Service

Time frame: Week 11. Mean (Standard Deviation). Unit: unscheduled visits

Measure	Intervention n = 89	Control n = 91
Number of emergency room visits	0.27 (0.78)	0.65 (2.85)
Number of urgent care center visits	0.09 (0.33)	0.12 (0.39)
Number of Hospitalizations	0.76 (1.19)	1.05 (0.61)

Population analysed: Participant outcome data collected at week 11

Adverse events

Time frame: Adverse events were tracked for unexpected foot effect at weeks 1-11. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 128 (0%)	0 of 128 (0%)	2 of 128
Control	0 of 128 (0%)	0 of 128 (0%)	1 of 128

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31267277Sikorskii A, Niyogi PG, Victorson D, Tamkus D, Wyatt G. Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer. Support Care Cancer. 2020 Mar;28(3):1395-1404. doi: 10.1007/s00520-019-04959-y. Epub 2019 Jul 2.
Derived from this study: PubMed 30552595Luo Z, Wang L, Sikorskii A, Wyatt G. Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women. Support Care Cancer. 2019 Aug;27(8):2837-2847. doi: 10.1007/s00520-018-4592-4. Epub 2018 Dec 14.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reflexology in people with Breast Cancer, run by Michigan State University at 9 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 5 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. 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?

Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The M.D. Anderson Symptom Inventory (MDASI) (time frame: Week 5 and week 11). The study lists 4 primary outcomes in all. 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 NCT01582971, which also lists 2 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 18 Apr 2018.