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Telehealth cognitive behaviour therapy for sleep disturbance in breast cancer patients receiving chemotherapy

Phase II trial of adherence to telehealth cognitive behaviour therapy for the management of sleep disturbance in women with early breast cancer receiving chemotherapy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001379909
Enrollment
41
Registered
2020-12-22
Start date
2021-07-26
Completion date
2022-07-19
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine the feasibility and acceptability of telehealth cognitive behaviour therapy for sleep disturbance in women with breast cancer receiving chemotherapy. Who is it for? You may be eligible for this study if you are a women aged 18 years and over, stage I-III breast cancer and scheduled to receive chemotherapy Study details Participants will receive telehealth cognitive behaviour therapy for sleep whilst receiving chemotherapy. The cognitive behaviour therapy program consists of four sessions, delivered every two weeks over eight weeks. Participants decide if they would like to receive the sessions on the phone or online video conference. Each session takes 45 to 75 minutes to complete. Participants will complete questionnaires and complete a sleep diary during the trial. It is hoped this research will demonstrate if it is practical and useful for women to complete the program whilst receiving chemotherapy for breast cancer.

Interventions

The telehealth cognitive behaviour therapy for insomnia (CBT-I) program consists of four sessions delivered every two weeks over eight weeks. The CBT-I will be provided by provisionally registered psychologists who are all students in the University of Sydney Masters of Clinical Psychology course under the supervision of a senior clinical psychologist. Each session takes 45-75 minutes to complete, incorporating sleep education, sleep hygiene, stimulus control, sleep restriction, cognitive restru

The telehealth cognitive behaviour therapy for insomnia (CBT-I) program consists of four sessions delivered every two weeks over eight weeks. The CBT-I will be provided by provisionally registered psychologists who are all students in the University of Sydney Masters of Clinical Psychology course under the supervision of a senior clinical psychologist. Each session takes 45-75 minutes to complete, incorporating sleep education, sleep hygiene, stimulus control, sleep restriction, cognitive restructuring and relaxation training. Participants will choose whether they would like to receive the telehealth CBT-I sessions via telephone or online videoconference. Participants will commence the telehealth CBT-I before their second cycle of chemotherapy; this can be before or after their first cycle of chemotherapy. We will measure completion rate of all four sessions.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) Age 18 years or older b) Female c) Stage I-III breast cancer d) Scheduled to receive neo-adjuvant and/or adjuvant chemotherapy e) Willing and able to complete study questionnaires in English f) Written informed consent to participate in the trial

Exclusion criteria

a) Metastatic breast cancer (stage IV) b) Diagnosis of sleep disorder, such as obstructive sleep apnoea, narcolepsy, restless legs syndrome and REM sleep disorder behaviour. c) Current use of continuous positive airway pressure (CPAP) machine for sleep apnoea d) Currently receiving cognitive behaviour therapy (CBT) e) Working >1 overnight shift per fortnight on a regular basis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026