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Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer


N/A
18 Years
85 Years
Not Enrolling
Female
Stage, Breast Cancer

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Trial Information

Feasibility of Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy for Breast Cancer


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.


Inclusion Criteria:



- stage I-III breast cancer referred for chemotherapy

- English speaking

- over age 18

Exclusion Criteria:

1. Pregnancy (by self-report; poor sleep and fatigue are sometimes associated with
pregnancy);

2. Metastatic or unresectable breast cancer;

3. Patients who have been told they have sleep apnea, restless legs or periodic limb
movements in sleep whether or not they are currently treated;

4. History of bipolar disorder or history of mania;

5. Current diagnosis of psychotic disorder;

6. Blindness or other physical or psychological impairments which would limit
participation;

7. Shift workers;

8. Women with infants who still disturb the mother's sleep.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

fatigue

Outcome Description:

Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Sonia Ancoli-Israel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSD

Authority:

United States: Institutional Review Board

Study ID:

120108

NCT ID:

NCT01542983

Start Date:

March 2012

Completion Date:

December 2012

Related Keywords:

  • Stage, Breast Cancer
  • breast cancer
  • bright light
  • insomnia
  • fatigue
  • Breast Neoplasms
  • Fatigue

Name

Location

Moores UCSD Cancer CenterLa Jolla, California  92093-0658