Clinical trial NCT02759146: Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
Official title: Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-05-03
Enrollment: 347
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

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.

Primary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: Week 1 -Week 4
measure: The MD Anderson Symptom Inventory (MDASI)- Distress
timeFrame: Weeks 1-4
measure: The MD Anderson Symptom Inventory (MDASI)- Summed Severity
timeFrame: Weeks 1-4
measure: The MD Anderson Symptom Inventory (MDASI)- Sadness
timeFrame: Weeks 1-4
Secondary outcomes:
measure: Brief Fatigue Inventory (BFI)
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Summed Severity
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Distress
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Sadness
timeFrame: Weeks 5-12
measure: Brief Fatigue Inventory (BFI)
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Distress
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Sadness
timeFrame: Weeks 5-12
measure: MD Anderson Symptom Inventory (MDASI)- Summed Severity
timeFrame: Weeks 5-12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Lansing
country: United States
facility: MSU Breslin Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
Study officials:
affiliation: Michigan State University College of Nursing
name: Gwen Wyatt, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thana K, Sikorskii A, Lehto R, Guhaniyogi P, Brewer S, Victorson D, Pace T, Badger T, Wyatt G. Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial. Support Care Cancer. 2022 Jul;30(7):5891-5902. doi: 10.1007/s00520-022-07012-7. Epub 2022 Apr 5.