Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy

January 22, 2019 updated by: Sonia Ancoli-Israel, University of California, San Diego

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment-as-usual
Treatment as usual for fatigue and insomnia
Behavioral: treatment as usual
Standard treatment for fatigue and insomnia
Active Comparator: Behavioral treatment
Brief behavioral treatment for insomnia and bright light Light and BBTI combined treatment for insomnia and fatigue
Behavioral: Brief behavioral treatment for insomnia and bright light
daily bright light exposure; 2 sessions for insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue
Time Frame: 12 weeks
Change in fatigue from pre-chemotherapy to post cycle 4 chemotherapy
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep
Time Frame: 12 weeks
Changes in sleep and sleep quality will be assessed from pre-chemotherapy to post-cycle 4 chemotherapy
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Sonia Ancoli-Israel, PhD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 26, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study never funded. No data to share

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage, Breast Cancer

Clinical Trials on treatment as usual

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe