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Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Primary Purpose

Insomnia, Fatigue, Breast Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

armodafinil

Placebo Comparator

CBT-I

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring Insomnia, Fatigue, QOL, CBT, Breast cancer, Survivors, Chemotherapy

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of cancer.
Be able to understand written and spoken English
Be able to swallow medication
Have preferred sleep phase between 7:30 pm and 11:00 am
Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period
Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment
Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.)
Report insomnia on the SDS-CL at a frequency of at least 3 days a week

Exclusion Criteria:

Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component.
Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years)
Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
Be presently taking an anticoagulant or a corticosteroid
Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days
Be currently pregnant or nursing
Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders Identification Test (AUDIT) score >=13
Have surgery planned within the study period
Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.

Sites / Locations

University of Rochester James P. Wilmot Cancer Center
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

1 - CBT-I + placebo

2 - CBT-I + Armodafinil

3 - Placebo only

4 - Armodafinil only

Arm Description

CBT-I and placebo

CBT-I + Armodafinil

Placebo only

Armodafinil only

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index From Baseline to Post-intervention

The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.

Secondary Outcome Measures

Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue "now," and fatigue at its "worst" and "usual" for the last 24 hours. The 11-point scales are bounded by 0 = "no fatigue" and 10 = "fatigue as bad as you can imagine." Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = "does not interfere" and 10 = "interferes completely." A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.

Full Information

NCT ID

NCT01091974

First Posted

December 9, 2009

Last Updated

December 16, 2016

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01091974

Brief Title

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Official Title

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Detailed Description

Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated. Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study. CBT-I (Arms 3 & 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 & 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy. Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Fatigue, Breast Cancer

Keywords

Insomnia, Fatigue, QOL, CBT, Breast cancer, Survivors, Chemotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - CBT-I + placebo

Arm Type

Experimental

Arm Description

CBT-I and placebo

Arm Title

2 - CBT-I + Armodafinil

Arm Type

Experimental

Arm Description

CBT-I + Armodafinil

Arm Title

3 - Placebo only

Arm Type

Placebo Comparator

Arm Description

Placebo only

Arm Title

4 - Armodafinil only

Arm Type

Experimental

Arm Description

Armodafinil only

Intervention Type

Drug

Intervention Name(s)

armodafinil

Intervention Description

Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator

Intervention Description

Placebo for 47 days

Intervention Type

Behavioral

Intervention Name(s)

CBT-I

Intervention Description

Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Primary Outcome Measure Information:

Title

Change in Insomnia Severity Index From Baseline to Post-intervention

Description

Time Frame

ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Secondary Outcome Measure Information:

Title

Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

Description

Time Frame

ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of cancer. Be able to understand written and spoken English Be able to swallow medication Have preferred sleep phase between 7:30 pm and 11:00 am Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted Self-report problems with insomnia for at least three months and that the insomnia began or got worse with the onset of cancer or treatment Have completed chemotherapy and or radiation not less than one month ago. Note: Both types of treatment must be completed at least one month ago if patient receives chemotherapy and radiation therapy and there is no outer limit to how long ago treatments were completed.) Report insomnia on the SDS-CL at a frequency of at least 3 days a week Exclusion Criteria: Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this protocol will be defined as any cognitive behavioral-based treatment for insomnia that includes a sleep restriction component. Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years) Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension Be presently taking an anticoagulant or a corticosteroid Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days Be currently pregnant or nursing Have a history of substance abuse, or meet criteria for current alcohol abuse or dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders Identification Test (AUDIT) score >=13 Have surgery planned within the study period Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom Check at the "Often" or "Frequently" level.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph A Roscoe, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester James P. Wilmot Cancer Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30621831

Citation

Peoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors. J Clin Sleep Med. 2019 Jan 15;15(1):129-137. doi: 10.5664/jcsm.7586.

Results Reference

derived

PubMed Identifier

25452447

Citation

Roscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015 Jan 10;33(2):165-71. doi: 10.1200/JCO.2014.57.6769. Epub 2014 Dec 1.

Results Reference

derived

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Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

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