Prophylactic Treatment of Sleep/Fatigue Before and During Chemotherapy

NCT01542983 | Withdrawn

• 1 other identifier: 120108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stage, Breast Cancer

Keywords

breast cancer; bright light; insomnia; fatigue

Outcome Measures

Primary Outcomes (1)

• fatigue

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

  12 weeks

Secondary Outcomes (1)

• sleep

  12 weeks

Study Arms (2)

Treatment-as-usual

ACTIVE COMPARATOR

Treatment as usual for fatigue and insomnia

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

Behavioral: Brief behavioral treatment for insomnia and bright light

Interventions

Brief behavioral treatment for insomnia and bright light BEHAVIORAL

daily bright light exposure; 2 sessions for insomnia

Behavioral treatment

treatment as usual BEHAVIORAL

Standard treatment for fatigue and insomnia

Treatment-as-usual

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage I-III breast cancer referred for chemotherapy
• English speaking
• over age 18

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sonia Ancoli-Israel, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: March 2, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)