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Insomnia Interventions in Cancer Survivors

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Cooper University Health Care

Status

Unknown

Conditions

Insomnia

Treatments

Behavioral: MBSR
Behavioral: CBT

Study type

Interventional

Funder types

Other

Identifiers

NCT02783079
15-146EX

Details and patient eligibility

About

This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

Full 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.

Enrollment

210 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

210 participants in 2 patient groups

Arm 1
Active Comparator group
Description:
Cognitive Behavioral Therapy (CBT)
Treatment:
Behavioral: CBT
Arm 2
Active Comparator group
Description:
Mindfulness Based Stress Reduction (MBSR)
Treatment:
Behavioral: MBSR

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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