CancerNCT02759146

Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

A study testing Reflexology and Meditative Practices in people with Cancer, run by Michigan State University at 7 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cancer
What is being tested?: Reflexology and Meditative Practices
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 347 participants
Where: 7 sitesUnited States
Study dates: May 2016to Nov 2019
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 year of age or older
Solid tumor cancer diagnosis
Able to perform basic activities of daily living (ADLs)
Undergoing chemotherapy, hormonal therapy, or targeted therapy
Able to speak and understand English
Have access to a telephone
Able to hear normal conversation
Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.

Who cannot join

Diagnosis of major mental illness on the medical record (verified by the recruiter)
Residing in a nursing home
Bedridden
Currently receiving reflexology or meditative practices
Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Northwestern University
Chicago, Illinois, 60611
Karmanos Cancer Institute
Detroit, Michigan, 48201
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
MSU Breslin Cancer Center
Lansing, Michigan, 48910
Sparrow Cancer Center
Lansing, Michigan, 48912
Arizona Oncology
Tucson, Arizona, 85704
University of Arizona
Tucson, Arizona, 85721

Other trials in United States

About this study

The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.

Read the detailed description

First, dyads were randomized to receive caregiver-delivered reflexology or meditative practice. Fatigue severity was assesses weekly via phone calls to the cancer patients during weeks 1-4 of the intervention. For patients who did not respond to the intervention during the first 4 weeks, those dyads were referred to as non-responder and re-randomized. A non-responder was determined if the level of reported fatigue remained the same or increased from the first week of the intervention.

The re-randomization placed the non-responders in either a group that received a higher dose (more time) with the first intervention or to the alternate practice (meditative practice to those randomized to reflexology and vice versa) for weeks 5-8. Those who did respond during weeks 1-4 continued the same therapy they began with.

Conditions: Cancer
Being tested: Reflexology, Meditative Practices
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReflexologyOther
Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Meditative PracticesOther
Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns

Study groups in NCT02759146
Study group	Role	What they receive
Reflexology	Experimental	Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms. Receives: Other: Reflexology
Meditative Practice	Experimental	Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns Receives: Other: Meditative Practices
Control	No intervention	Control - no intervention

What is being measured

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

Brief Fatigue Inventory (BFI)
Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Measured: Week 1 -Week 4
The MD Anderson Symptom Inventory (MDASI)- Distress
Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
Measured: Weeks 1-4
The MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome
Measured: Weeks 1-4
The MD Anderson Symptom Inventory (MDASI)- Sadness
Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome
Measured: Weeks 1-4

Secondary outcomes (8)

Brief Fatigue Inventory (BFI)
Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Distress
Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Sadness
Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome
Measured: Weeks 5-12
Brief Fatigue Inventory (BFI)
Aim 4: Average severity of fatigue for weeks 5-12 across initial 3 arms of study. The BFI instrument consists of nine items. The first three items ask respondents to rate the severity of fatigue "right now," at its "usual" level during the past 24 hours and at its "worst" level during the past 24 hours.
Score range: 0-10 where 0 = no fatigue and 10 = as bad as you can imagine Higher score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Distress
Aim 4: Average severity of distress for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Sadness
Aim 4: Average severity of sadness for weeks 5-12 Score range: 0-10 Higher score means worse outcome
Measured: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Aim 4: Comparing average severity of symptoms for weeks 5-12 Summed score range: 0-180 Higher score means worse outcome
Measured: Weeks 5-12

Timeline

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

May 2016Nov 2019

First posted3 May 2016 (estimated)
Study startMay 2016
Primary completionNov 2019
Study completionNov 2019

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 (1)Papers the sponsor has linked to this study.
Other trials for 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: Investigator
Enrolment: 347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02759146
Sponsor's protocol ID: PA13-165
Other IDs: R01CA193706
Status last verified: Sep 2020
First submitted: 21 Apr 2016
Last updated: 16 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Findings from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings.

Publications

Thana K, Sikorskii A, Lehto R, Guhaniyogi P, Brewer S, Victorson D, Pace T, Badger T, Wyatt G. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5.
PubMed 35378595

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 Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
ClinicalTrials.gov ID: NCT02759146
Acronym / sponsor ID: PA13-165
Conditions: Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 347 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: May 2016 (actual)
Primary completion: Nov 2019 (actual)
Study completion: Nov 2019 (actual)
First posted: 3 May 2016 (estimated)
Results: Posted 16 Dec 2020

Clinical summary

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

The purpose of this study is to compare reflexology to meditative practices to reduce symptoms in cancer patients.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Reflexology	Experimental	Other: ReflexologyReflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
Meditative Practice	Experimental	Other: Meditative PracticesMeditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
Control	No intervention	–Control - no intervention

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

21 year of age or older
Solid tumor cancer diagnosis
Able to perform basic activities of daily living (ADLs)
Undergoing chemotherapy, hormonal therapy, or targeted therapy
Able to speak and understand English

Key exclusion criteria (5 listed)

Diagnosis of major mental illness on the medical record (verified by the recruiter)
Residing in a nursing home
Bedridden
Currently receiving reflexology or meditative practices
Suspected or diagnosed deep vein thrombosis or painful foot neuropathy.

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
ReflexologyReflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.	Other	Reflexology
Meditative PracticesMeditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns	Other	Meditative Practice

Primary outcome

Brief Fatigue Inventory (BFI)
Time frame: Week 1 -Week 4
Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Distress
Time frame: Weeks 1-4
Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Summed Severity
Time frame: Weeks 1-4
Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome
The MD Anderson Symptom Inventory (MDASI)- Sadness
Time frame: Weeks 1-4
Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome

8 secondary outcomes

Brief Fatigue Inventory (BFI)
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Distress
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Sadness
Time frame: Weeks 5-12
Brief Fatigue Inventory (BFI)
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Distress
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Sadness
Time frame: Weeks 5-12
MD Anderson Symptom Inventory (MDASI)- Summed Severity
Time frame: Weeks 5-12

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reflexology With Response, Then Continued Reflexology	57	56
Reflexology Non-responders, Then Continued Reflexology	36	34
Reflexology Non-responders, Then Switch to Meditation	33	32
Control	44	44
Meditative Practice With Response, Continued Meditation	49	49
Meditative Practice Non-responders, Continued Meditation	30	29
Meditative Practice Non-responders, Switch to Reflexology	27	26

Primary outcome: Brief Fatigue Inventory (BFI)

Time frame: Week 1 -Week 4. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reflexology Patients n = 120	Meditative Practice Patients n = 97	Control Patients n = 42
Value	4.17 (0.17)	4.08 (0.18)	4.32 (0.26)

Reflexology Patients vs Meditative Practice Patients: Difference between least squared means: 0.09 (95% CI -.36 to .52), p = .72, Mixed Models Analysis
Reflexology Patients vs Control Patients: Difference between least squared means: -0.15 (95% CI -.72 to .41), p = .58, Mixed Models Analysis
Meditative Practice Patients vs Control Patients: Difference between least squared means: -0.24 (95% CI -.81 to .34), p = .42, Mixed Models Analysis

Primary outcome: The MD Anderson Symptom Inventory (MDASI)- Distress

Time frame: Weeks 1-4. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reflexology n = 120	Meditative Practice n = 97	Control n = 42
Value	2.20 (0.17)	2.21 (0.17)	2.40 (0.25)

Reflexology vs Meditative Practice: Difference between least squared means: -0.01 (95% CI -0.44 to 0.42), p = 0.96, Mixed Models Analysis
Reflexology vs Control: Difference between least squared means: -0.2 (95% CI -0.75 to 0.35), p = 0.48, Mixed Models Analysis
Meditative Practice vs Control: Difference between least squared means: -0.19 (95% CI -0.75 to 0.38), p = 0.52, Mixed Models Analysis

Primary outcome: The MD Anderson Symptom Inventory (MDASI)- Summed Severity

Time frame: Weeks 1-4. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reflexology n = 120	Meditative Practice n = 97	Control n = 42
Value	29.99 (1.27)	29.32 (1.30)	32.52 (1.87)

Reflexology vs Meditative Practice: Difference between least squared means: 0.67 (95% CI -2.52 to 3.86), p = .68, Mixed Models Analysis
Reflexology vs Control: Difference between least squared means: -2.53 (95% CI -6.64 to 1.58), p = .23, Mixed Models Analysis
Meditative Practice vs Control: Difference between least squared means: -3.2 (95% CI -7.41 to 1.01), p = 0.14, Mixed Models Analysis

Primary outcome: The MD Anderson Symptom Inventory (MDASI)- Sadness

Time frame: Weeks 1-4. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reflexology Patients n = 120	Meditative Practice Patients n = 97	Control Patients n = 42
Value	1.79 (0.15)	1.78 (0.16)	2.03 (0.23)

Reflexology Patients vs Meditative Practice Patients: Difference between least squared means: 0.01 (95% CI -0.38 to 0.39), p = 0.98, Mixed Models Analysis
Reflexology Patients vs Control Patients: Difference between least squared means: -0.24 (95% CI -0.74 to 0.25), p = 0.34, Mixed Models Analysis
Meditative Practice Patients vs Control Patients: Difference between least squared means: -0.25 (95% CI -0.76 to 0.26), p = 0.34, Mixed Models Analysis

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected over 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reflexology	0 of 150 (0%)	0 of 150 (0%)	4 of 150
Meditative Practice	0 of 150 (0%)	0 of 150 (0%)	5 of 150
Control	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35378595Thana K, Sikorskii A, Lehto R, Guhaniyogi P, Brewer S, Victorson D, Pace T, Badger T, Wyatt G. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5.
Individual participant dataSharing planned: Yes. Findings from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings.

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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 College of Nursing

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

Questions about this trial

What is this clinical trial studying?

A study testing Reflexology and Meditative Practices in people with Cancer, run by Michigan State University at 7 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 16 Dec 2020). 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?

Brief Fatigue Inventory (BFI) (time frame: Week 1 -Week 4). 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 NCT02759146, which also lists 1 linked publication.

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 16 Dec 2020.