NCT02759146

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2016

Typical duration for not_applicable cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

April 21, 2016

Results QC Date

September 28, 2020

Last Update Submit

November 19, 2020

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

  • Brief Fatigue Inventory (BFI)

    Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome

    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

    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

    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

    Weeks 1-4

Secondary Outcomes (8)

  • Brief Fatigue Inventory (BFI)

    Weeks 5-12

  • MD Anderson Symptom Inventory (MDASI)- Summed Severity

    Weeks 5-12

  • MD Anderson Symptom Inventory (MDASI)- Distress

    Weeks 5-12

  • MD Anderson Symptom Inventory (MDASI)- Sadness

    Weeks 5-12

  • Brief Fatigue Inventory (BFI)

    Weeks 5-12

  • +3 more secondary outcomes

Study Arms (3)

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.

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

Other: Meditative Practices

Control

NO INTERVENTION

Control - no intervention

Interventions

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.

Reflexology
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

Meditative Practice

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arizona Oncology

Tucson, Arizona, 85704, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

MSU Breslin Cancer Center

Lansing, Michigan, 48910, United States

Location

Sparrow Cancer Center

Lansing, Michigan, 48912, United States

Location

Related Publications (1)

  • 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.

    PMID: 35378595DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Results Point of Contact

Title
Dr. Gwen Wyatt
Organization
Michigan State University
gwyatt@msu.edu
517-353-6672

Study Officials

  • Gwen Wyatt, PhD, RN

    Michigan State University College of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2016

First Posted

May 3, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 16, 2020

Results First Posted

December 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)