Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Reflexology; Other: Meditative Practices

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.

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control - no intervention
Experimental: Reflexology; 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; 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.
Experimental: Meditative Practice; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	Weeks 5-12

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Gwen Wyatt, PhD, RN, Michigan State University College of Nursing

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PA13-165; R01CA193706 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.