Management of Insomnia in Breast Cancer Patients
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Sponsor: National Cancer Institute (NCI)
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
Change History
11 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE2
▶ Show 6 earlier versions
-
Jan 2021 — Dec 2022 [monthly]
Completed PHASE2
-
Dec 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Nov 2018 — Dec 2018 [monthly]
Completed PHASE2
Status: Unknown Status → Completed · Phase: PHASE2_PHASE3 → PHASE2
-
Jul 2018 — Nov 2018 [monthly]
Unknown Status PHASE2_PHASE3
Status: Active Not Recruiting → Unknown Status
-
Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting PHASE2_PHASE3
-
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
- National Cancer Institute (NCI)
- Stanford University
For direct contact, visit the study record on ClinicalTrials.gov .