Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

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

Detailed Description
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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.

Official Title
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Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Other: Reflexology
* Other: Meditative Practices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflexology<br>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<br>* 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.<br>|
| Experimental: Meditative Practice<br>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<br>* 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<br>|
| No Intervention: Control<br>Control - no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory (BFI) | Aim 1: Average severity of fatigue over weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome | Week 1 -Week 4 | 
| The MD Anderson Symptom Inventory (MDASI)- Distress | Aim 1: Average severity of distress for weeks 1-4 Individual Score Range: 0-10 Higher score means worse outcome | Weeks 1-4 | 
| The MD Anderson Symptom Inventory (MDASI)- Summed Severity | Aim 1: Average severity of symptoms from weeks 1-4 Summed range: 0-180 Higher score means worse outcome | Weeks 1-4 | 
| The MD Anderson Symptom Inventory (MDASI)- Sadness | Aim 1: Average severity of sadness from weeks 1-4 Score range: 0-10 Higher score means worse outcome | Weeks 1-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory (BFI) | Aims 2 and 3: Average severity of fatigue for weeks 5-12 Score range: 0-10 Higher score means worse outcome | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Summed Severity | Aims 2 and 3: Average severity of symptoms for weeks 5-12 Summed range: 0-180 Higher score means worse outcome | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Distress | Aims 2 and 3: Average severity of distress for weeks 5-12 Score range: 0-10 High score means worse outcome | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Sadness | Aims 2 and 3: Average severity of sadness for weeks 5-12 Score range: 0-10 High score means worse outcome | Weeks 5-12 | 
| Brief Fatigue Inventory (BFI) | 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 | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Distress | Aim 4: Average severity of distress for weeks 5-12 Score range: 0-10 Higher score means worse outcome | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Sadness | Aim 4: Average severity of sadness for weeks 5-12 Score range: 0-10 Higher score means worse outcome | Weeks 5-12 | 
| MD Anderson Symptom Inventory (MDASI)- Summed Severity | Aim 4: Comparing average severity of symptoms for weeks 5-12 Summed score range: 0-180 Higher score means worse outcome | Weeks 5-12 |