Back to resultsA Self-Management Energy Conservation Program for Cancer-Related Fatigue
Primary Purpose
Cancer-related Problem/Condition, Cancer, Breast, Fatigue
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Self-management energy conservation
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer-related Problem/Condition focused on measuring Energy conservation, Self management
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.
Sites / Locations
- Lopburi Cancer Hospital
- Saraburi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-management energy conservation
Control
Arm Description
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.
The participants will be given two pamphlets (general issues about breast cancer and self-care activities for patients receiving chemotherapy) provided by the health care team at the study sites. The participants in the control group will be encouraged to maintain their current daily activities during the 12-week period The participants will wear a pedometer to record the number of steps which is one of the activity outcomes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Satisfaction
Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).
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.
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.
Physical Activity (objective measure)
A pedometer will be used to assess how many steps are taken each day.
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item questionnaire
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.
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.
Full Information
NCT ID
NCT03282214
First Posted
September 6, 2017
Last Updated
May 19, 2018
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), Praboromarajchanok Institute, Ministry of Public Health, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT03282214
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), Praboromarajchanok Institute, Ministry of Public Health, Thailand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition, Cancer, Breast, Fatigue
Keywords
Energy conservation, Self management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-management energy conservation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The participants will be given two pamphlets (general issues about breast cancer and self-care activities for patients receiving chemotherapy) provided by the health care team at the study sites. The participants in the control group will be encouraged to maintain their current daily activities during the 12-week period The participants will wear a pedometer to record the number of steps which is one of the activity outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Self-management energy conservation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cancer-related fatigue (CRF)
Description
A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.
Time Frame
Change from baseline CRF scores at 12 weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
at 12 weeks
Title
Satisfaction
Description
Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).
Time Frame
at 12 weeks
Title
The General Sleep Disturbance (GSD)
Description
A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.
Time Frame
Change from baseline GSD scores at 12 weeks
Title
Physical Activity (subjective measure)
Description
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.
Time Frame
Change from baseline GSLTPAG scores at 12 weeks
Title
Physical Activity (objective measure)
Description
A pedometer will be used to assess how many steps are taken each day.
Time Frame
Changes from baseline steps per day at 12 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The HADS is a 14-item questionnaire
Time Frame
Change from baseline HADS scores at 12 weeks
Title
Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)
Description
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.
Time Frame
Change from baseline SEMCDS scores at 12 weeks
Title
Fatigue Belief Questions (FBQ)
Description
A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.
Time Frame
Change from baseline FBQ scores at 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Thai women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
School of Nursing
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
Lopburi Cancer Hospital
City
Lopburi
ZIP/Postal Code
15000
Country
Thailand
Facility Name
Saraburi Hospital
City
Saraburi
ZIP/Postal Code
18000
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
Learn more about this trial
A Self-Management Energy Conservation Program for Cancer-Related Fatigue
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