Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Cancer Clinical Trial

Official title:

Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759146
• Other study ID #: PA13-165
• Secondary ID: R01CA193706
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 2019

Study information

• Verified date: September 2020
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	MSU Breslin Cancer Center	Lansing	Michigan
United States	Sparrow Cancer Center	Lansing	Michigan
United States	Arizona Oncology	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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