Status:
COMPLETED
A Self-Management Energy Conservation Program for Cancer-Related Fatigue
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
Ministry of Health, Thailand
Conditions:
Cancer-related Problem/Condition
Cancer, Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this pilot study is to examine a 12-week self-management energy conservation program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and depression, se...
Detailed Description
Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has explored the efficacy of energy conservation interventions for fatigue and related symptoms but no previous...
Eligibility Criteria
Inclusion
- Thai women are age 18 or older; are diagnosed with stage I-III breast cancer; are scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals; report at least 4 out of 10 or higher on a fatigue scale in the past month; are able to read and write in Thai and can be contacted by telephone.
Exclusion
- Thai women have a history of severe psychiatric illness, or have other illnesses that could be responsible for the fatigue other than cancer such as iron deficiency anemia, multiple sclerosis, congestive heart failure, chronic fatigue syndrome or fibromyalgia. With regard to anemia, women must have a certain hemoglobin in the normal range at baseline. They also cannot have acute or chronic bone, joint, or muscular abnormalities that would increase the risk of falls and injury. Women scheduled to receive concurrent radiation therapy are not eligible.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03282214
Start Date
October 1 2017
End Date
May 9 2018
Last Update
May 22 2018
Active Locations (2)
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1
Saraburi Hospital
Changwat Sara Buri, Thailand, 18000
2
Lopburi Cancer Hospital
Lopburi, Thailand, 15000