A Self-Management Energy Conservation Program for Cancer-Related Fatigue

Phase 2

Completed

• Conditions: Cancer-related Problem/Condition; Cancer, Breast; Fatigue
• Interventions: Behavioral: Self-management energy conservation

• Registration Number: NCT03282214
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Study Start: 2017-10-01
• Primary Completion: 2018-02-14
• Status Verified: 2018-05
• Study Completion: 2018-05-09
• Last Update Submitted: 2018-05-19
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management energy conservation	Self-management energy conservation	Thai women with breast cancer randomized to the group will receive four sessions approximately every three weeks with the PI. The women will be instructed on how to do a self-management energy conservation program.

Primary Outcome Measures

Name	Time	Method
Cancer-related fatigue (CRF)	Change from baseline CRF scores at 12 weeks	A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.

Secondary Outcome Measures

Name	Time	Method
Physical Activity (subjective measure)	Change from baseline GSLTPAG scores at 12 weeks	Godin Leisure-Time Physical Activity Questionnaire (GSLTPAQ): A 4-item self-administered questionnaire asking information about the number of times one engages in mild, moderate, and strenuous leisure-time physical activity bouts of at least 15 minutes duration in a week, and also asking how often participants typically engage in any regular activity until sweating or a racing heart on a scale of often, sometimes, never or rarely.
Hospital Anxiety and Depression Scale (HADS)	Change from baseline HADS scores at 12 weeks	The HADS is a 14-item questionnaire
Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)	Change from baseline SEMCDS scores at 12 weeks	This 6-item scale contain items will be used to measures self-reported current level of confidence to manage control the patient's symptoms, role function, emotional functioning, and communicating with physicians.
Physical Activity (objective measure)	Changes from baseline steps per day at 12 weeks	A pedometer will be used to assess how many steps are taken each day.
Acceptability	at 12 weeks	Open-ended questions will be used to ask about the most positive and negative aspects of the intervention, what modules did they use the most, what were barriers to using the intervention, what would they like to see added or deleted in future modules, and any suggestions on how the program could be improved.
The General Sleep Disturbance (GSD)	Change from baseline GSD scores at 12 weeks	A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.
Fatigue Belief Questions (FBQ)	Change from baseline FBQ scores at 12 weeks	A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.
Satisfaction	at 12 weeks	Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).

Trial Locations

Locations (2)

Lopburi Cancer Hospital; 🇹🇭 Lopburi, Thailand

Saraburi Hospital; 🇹🇭 Saraburi, Thailand