Stage, Breast CancerNCT01542983
Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy
A study testing Brief behavioral treatment for insomnia and bright light and treatment as usual in people with Stage, Breast Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Stage, Breast Cancer
- What is being tested?
- Brief behavioral treatment for insomnia and bright light and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I-III breast cancer referred for chemotherapy
- English speaking
- over age 18
Who cannot join
- Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with pregnancy);
- Metastatic or unresectable breast cancer;
- Patients who have been told they have sleep apnea, restless legs or periodic limb movements in sleep whether or not they are currently treated;
- History of bipolar disorder or history of mania;
- Current diagnosis of psychotic disorder;
- Blindness or other physical or psychological impairments which would limit participation;
- Shift workers;
- Women with infants who still disturb the mother's sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093
About this study
Official title: Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and quality of life.
Read the detailed description
Women with breast cancer (BC) report poor sleep and fatigue, occasionally before, and often during chemotherapy. These symptoms often last for months and even years after the end of cancer treatment, significantly burdening the patients' quality of life (QOL), decreasing their overall functional level and potentially hindering the patients' re-integration into productive society. Improvement in the domains of sleep and fatigue might result in overall improvement in QOL. The investigators have shown that women with breast cancer with a symptom cluster of poor sleep, fatigue and depressive symptoms before chemotherapy are more likely to manifest an increase in severity of these symptoms and decreased QOL during chemotherapy.
A randomized controlled treatment study is now warranted to examine whether concurrent treatment of sleep and fatigue, begun before chemotherapy and continuing during chemotherapy, will prevent deterioration of sleep and fatigue during chemotherapy, and since poor sleep and fatigue are related to mood, whether these improvements will then lead to improvements in the symptom cluster of sleep/fatigue/mood as well as in QOL and cognitive functioning during chemotherapy. Before a full study can be initiated, the investigators propose a pilot study to examine the feasibility of conducting this type of treatment study.
The main aims of this pilot study are:
AIM 1: To examine whether the investigators can recruit 20 women with newly diagnosed breast cancer, before they begin chemotherapy, whether or not they are currently experiencing poor sleep and fatigue, into a treatment study that aims at preventing or mitigating poor sleep, fatigue, depressive symptoms during chemotherapy.
AIM 2: To examine whether women recruited into this study will be compliant with the sleep/fatigue treatment for a full four cycles of chemotherapy.
The results of this study plus the preliminary scientific data collected will be used as pilot data for an RO1 with the following aims: Aim 1 - Symptom cluster of sleep/fatigue/mood: To examine the effects of concurrent treatment of poor sleep and fatigue, begun before the start of chemotherapy and continuing during chemotherapy, on the symptom cluster of sleep/fatigue/mood during chemotherapy (hypothesis 1: Women with newly diagnosed breast cancer treated concurrently with Brief Behavioral Treatment of Insomnia (BBTI) and morning bright light therapy (BLT) before the start of and during chemotherapy, will experience fewer symptoms within the cluster of poor sleep, fatigue, depressive symptoms during chemotherapy than women in the information-only control group). Aim 2 - QOL and Cognition: To examine the effects of concurrent treatment of poor sleep and fatigue, begun before the start of chemotherapy and continuing during chemotherapy, on cognitive functioning (as measured with a targeted neuropsychological test battery) and QOL during chemotherapy (hypothesis 2: Women with newly diagnosed breast cancer treated concurrently with BBTI and morning BLT before the start of and during chemotherapy, will experience less deterioration in cognitive functioning and better QOL during chemotherapy than women in the information-only control group).
The innovation of larger application will be that the study intervention is a dual modality intervention (BBTI and BWL), not previously studied in combination and that it ultimately seeks to shift the clinical practice paradigm from a reactive to a proactive, preventive cancer care model.
The investigators are proposing a clinical trial to treat all patients, whether or not they are currently experiencing problems with sleep and fatigue, with the goal of preventing or ameliorating the severity of symptoms during chemotherapy, and compare them to an information-only control group (IC) (see Fig. 1). This pilot study will help us determine the feasibility of such a study.
- Conditions
- Stage, Breast Cancer
- Being tested
- Brief behavioral treatment for insomnia and bright light, treatment as usual
- Keywords
- breast cancer, bright light, insomnia, fatigue
- Medical subject headings
- Breast Neoplasms, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief behavioral treatment for insomnia and bright lightBehavioural
daily bright light exposure; 2 sessions for insomnia
treatment as usualBehavioural
Standard treatment for fatigue and insomnia
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | Active comparator | Treatment as usual for fatigue and insomnia Receives: Behavioral: treatment as usual |
| Behavioral treatment | Active comparator | Brief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue Receives: Behavioral: Brief behavioral treatment for insomnia and bright light |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy
Measured: 12 weeks
Secondary outcomes (1)
sleep
Changes in sleep and sleep quality will be assessed from pre-chemotherapy to post-cycle 4 chemotherapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Study never funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage, Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Ancoli-Israel, University of California, San Diego
- Investigators
- Sonia Ancoli-Israel, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542983
- Sponsor's protocol ID
- 120108
- Status last verified
- Jan 2019
- First submitted
- 26 Feb 2012
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study never funded. No data to share
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT01542983
- Acronym / sponsor ID
- 120108
- Conditions
- Stage, Breast Cancer
- Keywords
- breast cancer, bright light, insomnia, fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Mar 2012 (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.
Women with breast cancer complain of poor sleep and fatigue during chemotherapy which affect their mood, their memory and their quality of life. The investigators are testing whether it is feasible to treat the poor sleep and fatigue with behavioral treatments, before the start of chemotherapy and whether improving sleep and fatigue will also improve mood, memory and quality of life.
Detailed description
Women with breast cancer (BC) report poor sleep and fatigue, occasionally before, and often during chemotherapy. These symptoms often last for months and even years after the end of cancer treatment, significantly burdening the patients' quality of life (QOL), decreasing their overall functional level and potentially hindering the patients' re-integration into productive society. Improvement in the domains of sleep and fatigue might result in overall improvement in QOL. The investigators have shown that women with breast cancer with a symptom cluster of poor sleep, fatigue and depressive symptoms before chemotherapy are more likely to manifest an increase in severity of these symptoms and decreased QOL during chemotherapy.
A randomized controlled treatment study is now warranted to examine whether concurrent treatment of sleep and fatigue, begun before chemotherapy and continuing during chemotherapy, will prevent deterioration of sleep and fatigue during chemotherapy, and since poor sleep and fatigue are related to mood, whether these improvements will then lead to improvements in the symptom cluster of sleep/fatigue/mood as well as in QOL and cognitive functioning during chemotherapy. Before a full study can be initiated, the investigators propose a pilot study to examine the feasibility of conducting this type of treatment study.
The main aims of this pilot study are:
AIM 1: To examine whether the investigators can recruit 20 women with newly diagnosed breast cancer, before they begin chemotherapy, whether or not they are currently experiencing poor sleep and fatigue, into a treatment study that aims at preventing or mitigating poor sleep, fatigue, depressive symptoms during chemotherapy.
AIM 2: To examine whether women recruited into this study will be compliant with the sleep/fatigue treatment for a full four cycles of chemotherapy.
The results of this study plus the preliminary scientific data collected will be used as pilot data for an RO1 with the following aims: Aim 1 - Symptom cluster of sleep/fatigue/mood: To examine the effects of concurrent treatment of poor sleep and fatigue, begun before the start of chemotherapy and continuing during chemotherapy, on the symptom cluster of sleep/fatigue/mood during chemotherapy (hypothesis 1: Women with newly diagnosed breast cancer treated concurrently with Brief Behavioral Treatment of Insomnia (BBTI) and morning bright light therapy (BLT) before the start of and during chemotherapy, will experience fewer symptoms within the cluster of poor sleep, fatigue, depressive symptoms during chemotherapy than women in the information-only control group). Aim 2 - QOL and Cognition: To examine the effects of concurrent treatment of poor sleep and fatigue, begun before the start of chemotherapy and continuing during chemotherapy, on cognitive functioning (as measured with a targeted neuropsychological test battery) and QOL during chemotherapy (hypothesis 2: Women with newly diagnosed breast cancer treated concurrently with BBTI and morning BLT before the start of and during chemotherapy, will experience less deterioration in cognitive functioning and better QOL during chemotherapy than women in the information-only control group).
The innovation of larger application will be that the study intervention is a dual modality intervention (BBTI and BWL), not previously studied in combination and that it ultimately seeks to shift the clinical practice paradigm from a reactive to a proactive, preventive cancer care model.
The investigators are proposing a clinical trial to treat all patients, whether or not they are currently experiencing problems with sleep and fatigue, with the goal of preventing or ameliorating the severity of symptoms during chemotherapy, and compare them to an information-only control group (IC) (see Fig. 1). This pilot study will help us determine the feasibility of such a study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | Active comparator | Behavioral: treatment as usualTreatment as usual for fatigue and insomnia |
| Behavioral treatment | Active comparator | Behavioral: Brief behavioral treatment for insomnia and bright lightBrief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage I-III breast cancer referred for chemotherapy
- English speaking
- over age 18
Key exclusion criteria (8 listed)
- Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with pregnancy);
- Metastatic or unresectable breast cancer;
- Patients who have been told they have sleep apnea, restless legs or periodic limb movements in sleep whether or not they are currently treated;
- History of bipolar disorder or history of mania;
- Current diagnosis of psychotic disorder;
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 |
|---|---|---|
| Brief behavioral treatment for insomnia and bright lightdaily bright light exposure; 2 sessions for insomnia | Behavioural | Behavioral treatment |
| treatment as usualStandard treatment for fatigue and insomnia | Behavioural | Treatment-as-usual |
Primary outcome
fatigue
Time frame: 12 weeks
Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy
1 secondary outcome
sleep
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No. Study never funded. No data to share
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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.
Sonia Ancoli-Israel, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief behavioral treatment for insomnia and bright light and treatment as usual in people with Stage, Breast Cancer, run by University of California, San Diego 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Jan 2019. 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. 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 was withdrawn before enrolling participants, so there are no results.
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: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2019.