Cancer-related Problem/ConditionPhase 2NCT03282214
A Self-Management Energy Conservation Program for Cancer-Related Fatigue
A Phase 2 study testing Self-management energy conservation in people with Cancer-related Problem/Condition and Cancer, Breast, run by University of Michigan at 2 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer-related Problem/Condition, Cancer, Breast, Fatigue
- What is being tested?
- Self-management energy conservation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Oct 2017to 9 May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Saraburi Hospital
Changwat Sara Buri, 18000
Lopburi Cancer Hospital
Lopburi, 15000
About this study
Official title: A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study
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.
Read the 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.
- Conditions
- Cancer-related Problem/Condition, Cancer, Breast, Fatigue
- Being tested
- Self-management energy conservation
- Keywords
- Energy conservation, Self management
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management energy conservationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-management energy conservation | Experimental | 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. Receives: Behavioral: Self-management energy conservation |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline CRF scores at 12 weeks
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes from baseline steps per day at 12 weeks
Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item questionnaire
Measured: 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.
Measured: 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.
Measured: Change from baseline FBQ scores at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2017
- Primary completion14 Feb 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ministry of Health, Thailand
- Responsible party
- Principal investigator, Wipasiri Naraphong, University of Michigan
- Investigators
- School of Nursing, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282214
- Sponsor's protocol ID
- D43TW009883
- Status last verified
- May 2018
- First submitted
- 6 Sep 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available
Publications
Naraphong W, Barton D. Self-Management Energy Conservation for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study. Oncol Nurs Forum. 2023 Apr 21;50(3):337-347. doi: 10.1188/23.ONF.337-347.
PubMed 37155976
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT03282214
- Acronym / sponsor ID
- D43TW009883
- Conditions
- Cancer-related Problem/Condition, Cancer, Breast, Fatigue
- Keywords
- Energy conservation, Self management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ministry of Health, Thailand
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management energy conservation | Experimental | Behavioral: Self-management energy conservationThai 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management energy conservationThe 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. | Behavioural | Self-management energy conservation |
Primary outcome
Cancer-related fatigue (CRF)
Time frame: 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.
8 secondary outcomes
Acceptability
Time frame: at 12 weeks
Satisfaction
Time frame: at 12 weeks
The General Sleep Disturbance (GSD)
Time frame: Change from baseline GSD scores at 12 weeks
Physical Activity (subjective measure)
Time frame: Change from baseline GSLTPAG scores at 12 weeks
Physical Activity (objective measure)
Time frame: Changes from baseline steps per day at 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline HADS scores at 12 weeks
Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)
Time frame: Change from baseline SEMCDS scores at 12 weeks
Fatigue Belief Questions (FBQ)
Time frame: Change from baseline FBQ scores at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 37155976Naraphong W, Barton D. Self-Management Energy Conservation for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study. Oncol Nurs Forum. 2023 Apr 21;50(3):337-347. doi: 10.1188/23.ONF.337-347.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School of Nursing study chair
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-management energy conservation in people with Cancer-related Problem/Condition and Cancer, Breast, run by University of Michigan at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue (CRF) (time frame: Change from baseline CRF scores at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.