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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 : Recruiting
First Posted : May 3, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gwen Wyatt, Michigan State University

Brief Summary:
In order to optimize symptom management, there must be a shift from fixed interventions "one size fits all" to adaptive interventions tailored to individual patients. Our multistaged interventions use the sequential multiple assignment randomized trial (SMART) design. This design will operationalize the decision rules for switching from one intervention to another for individual patients. Our team's work to date with breast and lung cancer patients has shown efficacy for two home-based symptom management interventions, reflexology and meditative practices, delivered by or with friend or family caregivers. The sustainability of use of these two evidence based therapies and improvements in symptom outcomes will be tested during weeks 5-8 and at the week 12 follow up of 331 patients based on power analysis, against a control group. By sequencing two evidence based interventions, the proposed research will impact research and practice by determining how to maximize the benefit of symptom management during cancer treatment.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
Study Start Date : May 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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: Mindfulness Meditation
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
Other Name: Mindfulness

No Intervention: Control
Control - no intervention



Primary Outcome Measures :
  1. Brief Fatigue Inventory (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses change in fatigue

  2. Cognitive Function (Attentional Function Index) (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses change in cognitive functioning


Secondary Outcome Measures :
  1. M.D. Anderson Symptom Inventory (MDASI) minus fatigue (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses severity of symptoms

  2. PROMIS Depression and Anxiety SF 4 (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses depression and anxiety

  3. PROMIS Physical Function Short Form 8b (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses physical functioning

  4. Long-term Quality of Life Spiritual Subscale (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses long-term quality of life in relation to spirituality

  5. Multidimensional Scale of Perceived Social Support (MSPSS) (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses perceived social support


Other Outcome Measures:
  1. The MD Anderson Symptom Inventory (MDASI) Including Fatigue [ Time Frame: Weeks 2, 3, 4, 5, 6, 7, 8 ]
    Patient Instrument- assesses symptoms

  2. Patient Demographics [ Time Frame: Week 1 ]
    Patient Instrument- collects general information about the participant (eg. race, martial status, employment status...)

  3. Bayliss Tool (Chronic Conditions - without cancer) [ Time Frame: Week 1 ]
    Patient Instrument- assesses presence and severity of chronic conditions

  4. Medical Chart: Symptoms and Conditions [ Time Frame: 12 weeks ]
    Patient Instrument- chart review will be conducted by medical staff to gather information about symptoms and conditions

  5. Complementary Therapy Expectancy Scale (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Caregiver instrument & Patient instrument (identical)- assesses expectancy of therapy outcomes

  6. Complementary Therapy Utilization (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Patient Instrument- assesses current use of complementary therapies

  7. Satisfaction with Caregiver Involvement Survey [ Time Frame: Week 12 ]
    Patient Instrument- assesses satisfaction with caregiver involvement

  8. Debriefing Tool [ Time Frame: Week 12 ]
    Caregiver instrument & Patient instrument (identical)- assesses use of therapy and satisfaction with study participation

  9. PROMIS Profile 29 (change from baseline to week 12) [ Time Frame: Weeks 1 & 12 ]
    Caregiver instrument- assesses physical and emotional functioning

  10. Caregiver Demographics [ Time Frame: Week 1 ]
    Caregiver instrument- collects general information about the participant (eg. race, martial status, employment status...)

  11. Caregiver Reaction Assessment Tool (change from baseline to week 12) [ Time Frame: Week 1 & Week 12 ]
    Caregiver instrument- assesses feelings related to care giving

  12. Bayliss Tool (Chronic Conditions - with cancer) [ Time Frame: Week 1 ]
    Caregiver instrument- assesses presence and severity of chronic conditions

  13. Number of Weekly Sessions Completed [ Time Frame: Weeks 2, 3, 4, 5, 6, 7, and 8 ]
    Caregiver instrument- assesses number of weekly therapy sessions completed

  14. Satisfaction with Involvement Survey [ Time Frame: Week 12 ]
    Caregiver instrument- assesses satisfaction with involvement as a care giver



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


Contacts
Contact: Megan R Flanigan, RN, BSN 517-884-4630 megan.flanigan@hc.msu.edu

Locations
United States, Arizona
University of Arizona Active, not recruiting
Tucson, Arizona, United States, 85721
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Michigan
Cancer & Hematology Centers of Western Michigan Active, not recruiting
Grand Rapids, Michigan, United States, 49503
MSU Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Sponsors and Collaborators
Michigan State University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gwen Wyatt, PhD, RN Michigan State University College of Nursing

Responsible Party: Gwen Wyatt, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT02759146     History of Changes
Other Study ID Numbers: PA13-165
R01CA193706 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
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.