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

Fatigue Clinical Trial

Official title:

A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282214
• Other study ID #: D43TW009883
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: May 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 9, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Cancer-related Problem/Condition
• Fatigue

Intervention

Behavioral:
• Self-management energy conservation
The experimental group will receive four sessions approximately every three weeks with the PI. These sessions will correspond to the cycles of chemotherapy they will receive, with the first two sessions being during cycle 1, and sessions 3 and 4 being during cycles 2 and 3 of chemotherapy, respectively. The women will be instructed on how to assess their activity patterns by making a list prioritizing their usual activities. The journal and priority list (a "to do" list) provide the basis for the second session. In this session, the participant will learn to create a plan for managing valued activities to minimize the amount of energy used, to report the fatigue experienced during and after an activity done in the journal and will learn strategies to manage fatigue and optimize activity. In the third session, the participant will evaluate and revise their individualized plan. In addition, the participant will be instructed to wear a pedometer to record objective physical activity.

Locations

Country	Name	City	State
Thailand	Lopburi Cancer Hospital	Lopburi
Thailand	Saraburi Hospital	Saraburi

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH), Praboromarajchanok Institute, Ministry of Public Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related fatigue (CRF)	A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.	Change from baseline CRF scores at 12 weeks
Secondary	Acceptability	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.	at 12 weeks
Secondary	Satisfaction	Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).	at 12 weeks
Secondary	The General Sleep Disturbance (GSD)	A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.	Change from baseline GSD scores at 12 weeks
Secondary	Physical Activity (subjective measure)	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.	Change from baseline GSLTPAG scores at 12 weeks
Secondary	Physical Activity (objective measure)	A pedometer will be used to assess how many steps are taken each day.	Changes from baseline steps per day at 12 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS is a 14-item questionnaire	Change from baseline HADS scores at 12 weeks
Secondary	Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)	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.	Change from baseline SEMCDS scores at 12 weeks
Secondary	Fatigue Belief Questions (FBQ)	A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.	Change from baseline FBQ scores at 12 weeks