InsomniaNCT02783079
Insomnia Interventions in Cancer Survivors
A study testing CBT and MBSR in people with Insomnia, run by Cooper Norcross Health at 2 sites in United States.
Trial summary
This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- CBT and MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to May 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- age 18 and over
- diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic
- receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper
- Self reported insomnia
- Not currently taking any medications to treat insomnia
- No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
856-735-6100
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043
856-325-6750
About this study
This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.
Read the detailed description
The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.
- Conditions
- Insomnia
- Being tested
- CBT, MBSR
- Keywords
- Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Breast Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called cognitive behavioral therapy
MBSRBehavioural
Also called mindfulness based stress reduction
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Cognitive Behavioral Therapy (CBT) Receives: Behavioral: CBT |
| Arm 2 | Active comparator | Mindfulness Based Stress Reduction (MBSR) Receives: Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.
Measured: Baseline to 6 weeks and 6 weeks to 12 weeks
Secondary outcomes (3)
Change in Brief Fatigue Inventory (BFI)
Change in Fatigue rating using the BFI in cancer survivors receiving CBT vs. MBSR interventions.
Measured: Baseline to 6 weeks and 6 weeks to 12 weeks
Change in Depression, Anxiety and Stress Scale 21 (DASS21)
Change in Depression and Anxiety rating using the DASS21 in cancer survivors receiving CBT vs. MBSR interventions
Measured: Baseline to 6 weeks and 6 weeks to 12 weeks
Number of patients who respond to CBT vs MBSR based on Ethnicity
Variations in efficacy outcomes based on ethnicity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783079
- Sponsor's protocol ID
- 15-146EX
- Status last verified
- May 2016
- First submitted
- 12 Feb 2016
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia Interventions in Cancer Survivors
- ClinicalTrials.gov ID
- NCT02783079
- Acronym / sponsor ID
- 15-146EX
- Conditions
- Insomnia
- Keywords
- Breast Cancer, Prostate Cancer, Colon Cancer, Lung Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- First posted
- 26 May 2016 (estimated)
- 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.
This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.
Detailed description
The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: CBTCognitive Behavioral Therapy (CBT) |
| Arm 2 | Active comparator | Behavioral: MBSRMindfulness Based Stress Reduction (MBSR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed informed consent
- age 18 and over
- diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic
- receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper
- Self reported insomnia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CBTAlso: cognitive behavioral therapy | Behavioural | Arm 1 |
| MBSRAlso: mindfulness based stress reduction | Behavioural | Arm 2 |
Primary outcome
Change in Insomnia Severity Index
Time frame: Baseline to 6 weeks and 6 weeks to 12 weeks
Change in Insomnia Severity Index (ISI) rating ratings in cancer survivors receiving CBT vs. MBSR interventions.
3 secondary outcomes
Change in Brief Fatigue Inventory (BFI)
Time frame: Baseline to 6 weeks and 6 weeks to 12 weeks
Change in Depression, Anxiety and Stress Scale 21 (DASS21)
Time frame: Baseline to 6 weeks and 6 weeks to 12 weeks
Number of patients who respond to CBT vs MBSR based on Ethnicity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT and MBSR in people with Insomnia, run by Cooper Norcross Health at 2 sites 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: Baseline to 6 weeks and 6 weeks to 12 weeks). 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 26 May 2016.