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Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting

Brief Behavioral Intervention for Insomnia During Chemotherapy

PRIMARY OBJECTIVE(S):

The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans.

SECONDARY OBJECTIVE(S):

To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA).

   - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as
   herceptin).

   - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as
   herceptin) remaining.

   - Be at least 21 years of age.

   - Be able to understand written and spoken English.

   - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or
   got worse with diagnosis of cancer or treatment with chemotherapy (to exclude
   pre-existing, chronic insomnia).

   - Have a Karnofsky score >= 70 to ensure that patients are able to participate in
   intervention and assessments.

Exclusion Criteria

   - Have an unstable self-reported medical or psychiatric illness (Axis I - current or
   within the last 5 years).

   - Be currently pregnant or nursing (patients are monitored for pregnancy during
   chemotherapy and pregnant women in the first trimester are not administered
   chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance
   to the study).

   - Have a history of substance abuse or meet criteria for current alcohol abuse or
   dependence

   - Have a self-reported history of sleep apnea or restless leg syndrome (RLS)

   - Self-report or have a medical record of an unstable comorbid medical or psychiatric
   condition that would make it unsafe or impossible to adhere to the study protocol

   - Are unable or unwilling to discontinue anxiolytics within 4 hours of education
   sessions

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh
650-725-7011
Recruiting