Breast Cancer FemaleNCT03328169
Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
A study testing Mindfulness-Based Therapy and Cognitive Behavioral Therapy for Insomnia in people with Breast Cancer Female and Insomnia, run by George Washington University at 1 site in United States.
Trial summary
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Insomnia
- What is being tested?
- Mindfulness-Based Therapy and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
- completed active treatment (surgery, radiation, chemotherapy) at least three months prior
- within 5 years of treatment or still on adjuvant therapy
- Completes informed consent to participate
Who cannot join
- sleep apnea or restless leg syndrome
- practicing mindfulness techniques >1/wk
Trial locations and contacts
1 site in 1 country.
United States1 site
GW Center for Integrative Medicine
Washington D.C., District of Columbia, 20052
About this study
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.
Read the detailed description
The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.
- Conditions
- Breast Cancer Female, Insomnia
- Being tested
- Mindfulness-Based Therapy, Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based TherapyBehavioural
Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks.
Cognitive Behavioral Therapy for InsomniaBehavioural
A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Mindfulness | Experimental | Mindfulness-Based Therapy Receives: Behavioral: Mindfulness-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Measured: Nine weeks
Change in Insomnia
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
Measured: Nine weeks
Secondary outcomes (4)
Change in cognitive function
Measured via the FACT-Cog (Scale 0-132; higher is better)
Measured: Nine weeks
Change in cognitive function
Measured via the Montreal Cognitive Assessment (MOCA)
Measured: Nine weeks
Change in Fatigue
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse)
Measured: Nine weeks
Change in Insomnia
Measured using an actigraph
Measured: Nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start15 Apr 2017
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Arem, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328169
- Sponsor's protocol ID
- 121635
- Status last verified
- Aug 2018
- First submitted
- 24 Oct 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Feasibility Trial for Insomnia Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03328169
- Acronym / sponsor ID
- 121635
- Conditions
- Breast Cancer Female, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.
Detailed description
The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia |
| Mindfulness | Experimental | Behavioral: Mindfulness-Based TherapyMindfulness-Based Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Joint Committee on Cancer (AJCC) Stage I-III or Eastern Cooperative Oncology Group (ECOG) 0-1 breast cancer
- completed active treatment (surgery, radiation, chemotherapy) at least three months prior
- within 5 years of treatment or still on adjuvant therapy
- Completes informed consent to participate
Key exclusion criteria (2 listed)
- sleep apnea or restless leg syndrome
- practicing mindfulness techniques >1/wk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based TherapyParticipants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks. | Behavioural | Mindfulness |
| Cognitive Behavioral Therapy for InsomniaA licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature. | Behavioural | CBT-I |
Primary outcome
Change in Insomnia
Time frame: Nine weeks
Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia)
Change in Insomnia
Time frame: Nine weeks
Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse)
4 secondary outcomes
Change in cognitive function
Time frame: Nine weeks
Change in cognitive function
Time frame: Nine weeks
Change in Fatigue
Time frame: Nine weeks
Change in Insomnia
Time frame: Nine weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
Related trials for Breast Cancer Female
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
Recruiting
To Assess the Contribution of Sophrology Assisted by an Ambulatory Device on the Anxiety of Patients Undergoing Chemotherapy for the Treatment of Localized Breast Cancer
Breast Cancer Female
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruiting
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Breast Cancer Female, BRCA1 Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Therapy and Cognitive Behavioral Therapy for Insomnia in people with Breast Cancer Female and Insomnia, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia (time frame: Nine weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.