Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Michigan State University

Status: Completed

Conditions: Cancer

Treatments: Other: Meditative Practices; Other: Reflexology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02759146

R01CA193706 (U.S. NIH Grant/Contract)

PA13-165

Details and patient eligibility

About

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

Full 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.

Enrollment: 347 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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347 participants in 3 patient groups

Reflexology

Experimental group

Description:

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.

Treatment:

Other: Reflexology

Meditative Practice

Experimental group

Description:

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

Treatment:

Other: Meditative Practices

Control

No Intervention group

Description:

Control - no intervention