Trial Search Results

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy

This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-III cancer who are receiving chemotherapy. Chemotherapy can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

University of Rochester NCORP Research Base

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Behavioral Intervention
  • Behavioral: Behavioral Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be diagnosed with cancer stage I, II or III

   - Be currently receiving any cytotoxic chemotherapy (can be cytotoxic chemotherapy alone
   or in combination with biologics and/or antibodies)

   - Report sleep disturbance of 10 or greater (sum total of all 7 items) on the Insomnia
   Severity Index

   - Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG)
   performance status scale

   - Be able to speak, understand and read English to participate in the study assessments
   and interventions

Exclusion Criteria:

   - Be diagnosed with cancer stage IV

   - Have any type of unstable comorbid medical or psychiatric condition that would
   prohibit completion of study assessments or intervention per physician or physician's
   designee

   - Be scheduled to receive active radiation prior to the completion of BBT-CI/HEAL
   interventions

   - Have a documented or physician's diagnosis of obstructive sleep apnea or restless leg
   syndrome (even if controlled)

   - Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or
   in the past 30 days. Use of psychotropics and sleep medication are allowed

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting