Clinical trial NCT03282214: A Self-Management Energy Conservation Program for Cancer-Related Fatigue
Official title: A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer-related Problem/Condition
Cancer, Breast
Fatigue
Keywords: Energy conservation
Self management
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Ministry of Health, Thailand
First posted: 2017-09-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, self-efficacy, and beliefs about fatigue in a group of Thai women with breast cancer who are undergoing chemotherapy. We will also evaluate how well women like the intervention, how easy it is to use and whether women will do the activities.

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 ECAM programs have been tested in Thailand.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Cancer-related fatigue (CRF)
timeFrame: Change from baseline CRF scores at 12 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: at 12 weeks
measure: Satisfaction
timeFrame: at 12 weeks
measure: The General Sleep Disturbance (GSD)
timeFrame: Change from baseline GSD scores at 12 weeks
measure: Physical Activity (subjective measure)
timeFrame: Change from baseline GSLTPAG scores at 12 weeks
measure: Physical Activity (objective measure)
timeFrame: Changes from baseline steps per day at 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS scores at 12 weeks
measure: Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)
timeFrame: Change from baseline SEMCDS scores at 12 weeks
measure: Fatigue Belief Questions (FBQ)
timeFrame: Change from baseline FBQ scores at 12 weeks
Other outcomes:
Locations:
city: Lopburi
country: Thailand
facility: Lopburi Cancer Hospital
city: Saraburi
country: Thailand
facility: Saraburi Hospital
Study officials:
affiliation: University of Michigan
name: School of Nursing
role: STUDY_CHAIR
References: