N/A N=276 Randomized Single-blind Supportive Care

Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02759146 ↗

Enrolled (actual)

276

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Brief Fatigue Inventory (BFI) — 4.17; 4.08; 4.32 units on a scale — p=.72

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reflexology (Other); Meditative Practices (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Michigan State University
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Brief Fatigue Inventory (BFI)	3.62; 3.53; 3.87	0.42
PRIMARY The MD Anderson Symptom Inventory (MDASI)- Distress	2.20; 2.21; 2.40	0.96
PRIMARY The MD Anderson Symptom Inventory (MDASI)- Summed Severity	29.99; 29.32; 32.52	.68
PRIMARY The MD Anderson Symptom Inventory (MDASI)- Sadness	1.79; 1.78; 2.03	0.98
SECONDARY Brief Fatigue Inventory (BFI)	3.62; 3.53; 3.87	0.42
SECONDARY MD Anderson Symptom Inventory (MDASI)- Summed Severity	26.69; 25.77; 30.25	0.17
SECONDARY MD Anderson Symptom Inventory (MDASI)- Distress	1.78; 2.00; 2.20	0.15
SECONDARY MD Anderson Symptom Inventory (MDASI)- Sadness	1.75; 1.66; 2.02	0.33
SECONDARY Brief Fatigue Inventory (BFI)	3.62; 3.53; 3.87	0.42
SECONDARY MD Anderson Symptom Inventory (MDASI)- Distress	1.78; 2.00; 2.20	0.15
SECONDARY MD Anderson Symptom Inventory (MDASI)- Sadness	1.75; 1.66; 2.02	0.33
SECONDARY MD Anderson Symptom Inventory (MDASI)- Summed Severity	26.69; 25.77; 30.25	0.17

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02759146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.