A Phase 2 interventional study of Self-management energy conservation in Cancer-related Problem/Condition, Cancer, Breast and Fatigue, sponsored by University of Michigan. Completed at 2 sites in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by University of Michigan · Phase 2, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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.
Behavioral: Self-management energy conservation
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.
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.
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.
Time frame: Change from baseline CRF scores at 12 weeks
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.
Time frame: at 12 weeks
Satisfaction
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
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.
Time frame: Change from baseline GSD scores at 12 weeks
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.
Time frame: Change from baseline GSLTPAG scores at 12 weeks
Physical Activity (objective measure)
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
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item questionnaire
Time frame: Change from baseline HADS scores at 12 weeks
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.
Time frame: Change from baseline SEMCDS scores at 12 weeks
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.
Time frame: Change from baseline FBQ scores at 12 weeks
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be available
Supporting information: Study protocol
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University of Michigan