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Completed

NCT Number: NCT02759146

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Oncology, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflexology

Other

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 Practices

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 3, 2016
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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