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Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

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ClinicalTrials.gov Identifier: NCT02759146
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University

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

Condition or disease Intervention/treatment Phase
Cancer Other: Reflexology Other: Meditative Practices Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Arm Intervention/treatment
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

No Intervention: Control
Control - no intervention



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Brief Fatigue Inventory (BFI) [ Time Frame: Weeks 5-12 ]
    Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome

  2. MD Anderson Symptom Inventory (MDASI)- Summed Severity [ Time Frame: Weeks 5-12 ]
    Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome

  3. MD Anderson Symptom Inventory (MDASI)- Distress [ Time Frame: Weeks 5-12 ]
    Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome

  4. MD Anderson Symptom Inventory (MDASI)- Sadness [ Time Frame: Weeks 5-12 ]
    Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome

  5. Brief Fatigue Inventory (BFI) [ Time Frame: Weeks 5-12 ]

    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


  6. MD Anderson Symptom Inventory (MDASI)- Distress [ Time Frame: Weeks 5-12 ]
    Aim 4: Average severity of distress for weeks 5-12 Score range: 0-10 Higher score means worse outcome

  7. MD Anderson Symptom Inventory (MDASI)- Sadness [ Time Frame: Weeks 5-12 ]
    Aim 4: Average severity of sadness for weeks 5-12 Score range: 0-10 Higher score means worse outcome

  8. MD Anderson Symptom Inventory (MDASI)- Summed Severity [ Time Frame: Weeks 5-12 ]
    Aim 4: Comparing average severity of symptoms for weeks 5-12 Summed score range: 0-180 Higher score means worse outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759146


Locations
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United States, Arizona
Arizona Oncology
Tucson, Arizona, United States, 85704
University of Arizona
Tucson, Arizona, United States, 85721
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
MSU Breslin Cancer Center
Lansing, Michigan, United States, 48910
Sparrow Cancer Center
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Michigan State University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University College of Nursing
  Study Documents (Full-Text)

Documents provided by Gwen Wyatt, Michigan State University:
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Responsible Party: Gwen Wyatt, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT02759146    
Other Study ID Numbers: PA13-165
R01CA193706 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2016    Key Record Dates
Results First Posted: December 16, 2020
Last Update Posted: December 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.