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Completed PHASE2 INTERVENTIONAL 4-arm NCT01011218

Management of Insomnia in Breast Cancer Patients

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Sponsor: National Cancer Institute (NCI)

Updated 11 times since 2017 Last updated: Nov 1, 2018 Started: Jan 31, 2011 Primary completion: Jul 31, 2016 Completion: Jul 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01011218, this PHASE2 trial focuses on Fatigue and Insomnia and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 11 times since 2011, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans. Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity. Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced. Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotActive Not Recruiting~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshotUnknown Status~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshotCompleted~Dec 2018 – ~Jan 2021 · 25 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE2

  2. Dec 2018 — Jan 2021 [monthly]

    Completed PHASE2

  3. Nov 2018 — Dec 2018 [monthly]

    Completed PHASE2

    Status: Unknown StatusCompleted · Phase: PHASE2_PHASE3PHASE2

  4. Jul 2018 — Nov 2018 [monthly]

    Unknown Status PHASE2_PHASE3

    Status: Active Not RecruitingUnknown Status

  5. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  6. Jan 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    First recorded

Jan 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • Stanford University
Data source: Stanford University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations