Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01542983 |
| Other study ID # |
120108 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
December 2012 |
Study information
| Verified date |
January 2019 |
| Source |
University of California, San Diego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 sleep and fatigue will also improve mood, memory and
quality of life.
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.
