Breast CancerNCT00572416
Fatigue in Breast Cancer: A Behavioral Sleep Intervention
A study testing Individual Sleep Promotion Plan in people with Breast Cancer, run by University of Nebraska at 1 site in United States.
Trial summary
1. This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group 2. The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy 3. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Individual Sleep Promotion Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2003to 1 Jun 2006
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 19 and older
- Diagnosed for the first time with stage I-IIIA breast cancer
- Post-operative for breast cancer
- Scheduled to receive anthracycline-based adjuvant chemotherapy with our without taxane chemotherapy
- English speaking
- Karnofsky performance Scale score equal to or greater than 60
Who cannot join
- Comorbid diagnosis of chronic insomnia
- Sleep apnea or chronic fatigue syndrome
- Unstable congestive heart failure
- Chronic obstructive pulmonary disease
- Insulin-depenent diabetes
- Neruomuscular disease
Show all 10Show fewer
- Abnormal thryoid function
- Depression, or
- Treatment with steriods
- Erratic sleep schedule due to working rotating shifts
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Fatigue in Breast Cancer:A Behavioral Sleep Intervention
- This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group
- The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy
- The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and nighttime sleep,and to decrease physchological and symptom distress
- The healthy eating group receives equal time and attention and information on healthy eating
- All participants receive a research nurse visit 2 days prior to each chemotherapy treatment, and 30, 60, 90 days after the last treatment, and one-year after the first treatment.
- Adherence to the intervention is calculated at each time
- Reliable and valid instruments are used, including wrist actigraphy
Read the detailed description
Higher fatigue levels are found in women with stage I, II or IIIA breast cancer receiving adjuvant chemotherapy (CT) who adopt patterns of daytime inactivity and nighttime restlessness and have more symptom and psychological distress. Interventions that improve sleep quality and reduce daytime fatigue in persons with insomnia may also benefit women receiving adjuvant CT. Using selected factors from Piper's Integrated Fatigue Model (IFM), a randomized, controlled clinical trial will compare women with breast cancer who receive a four component behavioral sleep intervention to women in the attentional control group during and after adjuvant CT. The intervention is designed to reduce fatigue in these women by promoting daytime activity, improving sleep quality and decreasing symptom and psychological distress. The aims of this study are to: 1) Compare the immediate (sleep/wake, activity/exercise, symptoms, psychological distress) and consequent (fatigue) outcomes of women who receive a four component behavioral sleep intervention (sleep hygiene counseling, relaxation therapy, sleep restriction and stimulus control) (n=110) with the outcomes in the healthy eating group (n=110) in women with stage I, II or IIIA breast cancer during 4 or 8 cycles of adjuvant chemotherapy, at 30, 60 and 90 days after their last treatment, and 1 year after their first treatment; 2) Determine the extent to which factors selected from the IFM influence fatigue intensity levels a) in the total sample at baseline and b) differentially influence fatigue intensity levels between groups 30 days after the last chemotherapy treatment and 1 year after the first treatment and 3) Evaluate the adherence to the refined behavioral sleep intervention and preferences for sleep hygiene and relaxation therapy techniques in the experimental group over time. Women will be randomized on the basis of good or poor sleeping history and intent to treat (4 versus 8 cycles of CT) to the intervention or attentional control group. Using the co-scientist model, the sleep intervention group will follow an Individual Sleep Promotion Plan negotiated with the investigator with regularly scheduled reinforcements and revisions. The healthy eating group will receive equal time and attention regarding general topics and nutrition. Established instruments include the Piper Fatigue Scale, Hospital Anxiety and Depression Scale, SF-36 Health Survey, Symptom Experience Scale, Daily Diary and Pittsburgh Sleep Quality Index. Objective measures include wrist actigraph, hemoglobin/ hematocrit, white blood count, T4 \& TSH, and body mass index and a C - reactive protein at 1 year. Statistical analyses include RM-ANOVA, generalized estimation equation methodology and multiple regression analysis. Results may inform development of clinical guidelines for fatigue management during adjuvant CT.
- Conditions
- Breast Cancer
- Being tested
- Individual Sleep Promotion Plan, Healthy Eating Control
- Keywords
- fatigue, activity-rest, sleep-wake, psychological distress, symptom 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.
Individual Sleep Promotion PlanBehavioural
Four components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene
Healthy Eating ControlBehavioural
Equal time and attention and information about healthy eating
| Study group | Role | What they receive |
|---|---|---|
| 1 Individual Sleep Promotion Plan | Experimental | Four component behavioral sleep intervention comprised of activity-rest, sleep-wake, psychological distress and symptom management. Four components of the Individual Sleep Promotion Plan are: stimulus control, sleep restruction, relaxation, and sleep hygiene. Receives: Behavioral: Individual Sleep Promotion Plan |
| 2 Healthy Eating Control | Placebo comparator | Equal time and attention, information about healthy eating and general conversation Receives: Behavioral: Healthy Eating Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue as measured by Piper Fatigue Scale
Measured: 1 year
Secondary outcomes (4)
Activity-rest as measured by SF-36v2 and actigraphy
Activity-rest as measured by SF-36v2 and actigraphy
Measured: 1 year
Sleep-wake
Sleep-wake as measured by Pittsburgh Sleep Quality Index and actigraphy
Measured: 1 year
Psychological mood
Psychological mood as measured by Hospital Anxiety and Depression Scale
Measured: 1 year
Symptom experience
Symptom experience as measured by Symptom Experience Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study start1 Apr 2003
- Study completion1 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ann M Berger, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572416
- Sponsor's protocol ID
- 0140-02-FB
- Other IDs
- 5R01NR007762-05
- Status last verified
- Aug 2023
- First submitted
- 11 Dec 2007
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Berger AM, Farr LA, Kuhn BR, Fischer P, Agrawal S. Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior to adjuvant breast cancer chemotherapy. J Pain Symptom Manage. 2007 Apr;33(4):398-409. doi: 10.1016/j.jpainsymman.2006.09.022.
PubMed 17397701Berger AM, Neumark DE, Chamberlain J. Enhancing recruitment and retention in randomized clinical trials of cancer symptom management. Oncol Nurs Forum. 2007 Mar;34(2):E17-22. doi: 10.1188/07.ONF.E17-E22.
PubMed 17573292
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Breast Cancer:A Behavioral Sleep Intervention
- ClinicalTrials.gov ID
- NCT00572416
- Acronym / sponsor ID
- 0140-02-FB
- Conditions
- Breast Cancer
- Keywords
- fatigue, activity-rest, sleep-wake, psychological distress, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2003 (actual)
- Study completion
- 1 Jun 2006 (actual)
- First posted
- 13 Dec 2007 (estimated)
- 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.
- This randomized clinical trial compares a four component behavioral sleep intervention group to an attention control healthy eating group
- The behavioral sleep intervention is designed to reduce fatigue in women with stages I-IIIA breast cancer receiving anthracycline-based chemotherapy
- The intervention uses an Individual Sleep Promotion Plan to promote daytime activity and nighttime sleep,and to decrease physchological and symptom distress
- The healthy eating group receives equal time and attention and information on healthy eating
- All participants receive a research nurse visit 2 days prior to each chemotherapy treatment, and 30, 60, 90 days after the last treatment, and one-year after the first treatment.
- Adherence to the intervention is calculated at each time
- Reliable and valid instruments are used, including wrist actigraphy
Detailed description
Higher fatigue levels are found in women with stage I, II or IIIA breast cancer receiving adjuvant chemotherapy (CT) who adopt patterns of daytime inactivity and nighttime restlessness and have more symptom and psychological distress. Interventions that improve sleep quality and reduce daytime fatigue in persons with insomnia may also benefit women receiving adjuvant CT. Using selected factors from Piper's Integrated Fatigue Model (IFM), a randomized, controlled clinical trial will compare women with breast cancer who receive a four component behavioral sleep intervention to women in the attentional control group during and after adjuvant CT. The intervention is designed to reduce fatigue in these women by promoting daytime activity, improving sleep quality and decreasing symptom and psychological distress. The aims of this study are to: 1) Compare the immediate (sleep/wake, activity/exercise, symptoms, psychological distress) and consequent (fatigue) outcomes of women who receive a four component behavioral sleep intervention (sleep hygiene counseling, relaxation therapy, sleep restriction and stimulus control) (n=110) with the outcomes in the healthy eating group (n=110) in women with stage I, II or IIIA breast cancer during 4 or 8 cycles of adjuvant chemotherapy, at 30, 60 and 90 days after their last treatment, and 1 year after their first treatment; 2) Determine the extent to which factors selected from the IFM influence fatigue intensity levels a) in the total sample at baseline and b) differentially influence fatigue intensity levels between groups 30 days after the last chemotherapy treatment and 1 year after the first treatment and 3) Evaluate the adherence to the refined behavioral sleep intervention and preferences for sleep hygiene and relaxation therapy techniques in the experimental group over time. Women will be randomized on the basis of good or poor sleeping history and intent to treat (4 versus 8 cycles of CT) to the intervention or attentional control group. Using the co-scientist model, the sleep intervention group will follow an Individual Sleep Promotion Plan negotiated with the investigator with regularly scheduled reinforcements and revisions. The healthy eating group will receive equal time and attention regarding general topics and nutrition. Established instruments include the Piper Fatigue Scale, Hospital Anxiety and Depression Scale, SF-36 Health Survey, Symptom Experience Scale, Daily Diary and Pittsburgh Sleep Quality Index. Objective measures include wrist actigraph, hemoglobin/ hematocrit, white blood count, T4 \& TSH, and body mass index and a C - reactive protein at 1 year. Statistical analyses include RM-ANOVA, generalized estimation equation methodology and multiple regression analysis. Results may inform development of clinical guidelines for fatigue management during adjuvant CT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Individual Sleep Promotion Plan | Experimental | Behavioral: Individual Sleep Promotion PlanFour component behavioral sleep intervention comprised of activity-rest, sleep-wake, psychological distress and symptom management. Four components of the Individual Sleep Promotion Plan are: stimulus control, sleep restruction, relaxation, and sleep hygiene. |
| 2 Healthy Eating Control | Placebo comparator | Behavioral: Healthy Eating ControlEqual time and attention, information about healthy eating and general conversation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 19 and older
- Diagnosed for the first time with stage I-IIIA breast cancer
- Post-operative for breast cancer
- Scheduled to receive anthracycline-based adjuvant chemotherapy with our without taxane chemotherapy
- English speaking
Key exclusion criteria (10 listed)
- Comorbid diagnosis of chronic insomnia
- Sleep apnea or chronic fatigue syndrome
- Unstable congestive heart failure
- Chronic obstructive pulmonary disease
- Insulin-depenent diabetes
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 |
|---|---|---|
| Individual Sleep Promotion PlanFour components, including activity-rest, sleep-wake, psychological distress, and symptom management. Sleep-wake component has four strategies: stimulus control, sleep restriction, relaxation, and sleep hygiene | Behavioural | 1 Individual Sleep Promotion Plan |
| Healthy Eating ControlEqual time and attention and information about healthy eating | Behavioural | 2 Healthy Eating Control |
Primary outcome
Fatigue
Time frame: 1 year
Fatigue as measured by Piper Fatigue Scale
4 secondary outcomes
Activity-rest as measured by SF-36v2 and actigraphy
Time frame: 1 year
Sleep-wake
Time frame: 1 year
Psychological mood
Time frame: 1 year
Symptom experience
Time frame: 1 year
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 31 Aug 2023.
- Results publication: PubMed 17397701Berger AM, Farr LA, Kuhn BR, Fischer P, Agrawal S. Values of sleep/wake, activity/rest, circadian rhythms, and fatigue prior to adjuvant breast cancer chemotherapy. J Pain Symptom Manage. 2007 Apr;33(4):398-409. doi: 10.1016/j.jpainsymman.2006.09.022.
- Results publication: PubMed 17573292Berger AM, Neumark DE, Chamberlain J. Enhancing recruitment and retention in randomized clinical trials of cancer symptom management. Oncol Nurs Forum. 2007 Mar;34(2):E17-22. doi: 10.1188/07.ONF.E17-E22.
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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.
Ann M Berger, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Sleep Promotion Plan in people with Breast Cancer, run by University of Nebraska at 1 site in United States.
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 6 inclusion and 10 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fatigue (time frame: 1 year). 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 NCT00572416, which also lists 2 linked publications.
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 31 Aug 2023.