Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-15
Brief Title:
INvestigating the Value of Early Sleep Therapy
Sponsor:
University of Strathclyde
Organization:
University of Strathclyde
Study Overview
Official Title:
A Pilot Randomised Control Trial of Sleep Restriction Therapy Versus Sleep Hygiene Education for Newly Diagnosed Breast Cancer Patients With Acute Insomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVEST
Brief Summary:
Twenty percent of breast cancer survivors have insomnia which is defined as persistent trouble falling andor staying asleep that results in difficulty functioning during the day Sleep difficulties often begin at cancer diagnosis become worse during cancer treatment and continue into cancer survivorship Insomnia interferes with daily activities and may cause other mental and physical health problems It also makes it more difficult to cope with cancer treatment and makes recovery more challenging For these reasons it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia
Sleep Restriction Therapy is one such intervention which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment However it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance who are undergoing cancer treatment
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education SHE control intervention The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future larger study Throughout the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise
Sleep Restriction Therapy is one such intervention which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment However it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance who are undergoing cancer treatment
This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education SHE control intervention The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future larger study Throughout the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise
Detailed Description:
The primary aim of this project is to assess the feasibility and inform the design of a full-scale RCT of SRT for newly diagnosed breast cancer patients with acute insomnia Secondary aims of this project are to assess the effects of SRT alongside a sleep hygiene education SHE control on sleep rest-activity rhythms and mental health
Participants will be recruited from breast cancer results clinics in two study sites Our target population is newly diagnosed non-metastatic patients whose primary cancer treatment is surgery Participants will go through initial screening and will be sent an online participant information sheet and consent form Once consent form is signed marking enrolment in the study the second stage of screening will commence It involves assessing current sleep status based on diagnostic criteria for acute insomnia current psychiatric symptoms and review of other relevant medical information diagnosis of other sleep disorders other medical and psychiatric disorders This is to confirm the diagnosis of acute insomnia and establish that there are no medical or psychiatric conditions that might preclude someone from taking part in the study Once eligibility is ascertained patients will be randomly assigned to SRT or the SHE control group The investigators aim to randomise 50 patients n25 in each trial arm
After randomisation to SRT or SHE patients will be sent an email with a link to complete a baseline pre-intervention assessment of sleep fatigue and mental health Patients will also be required to complete the consensus sleep diary and wear an actigraphy device for 7 days prior to commencement of SRTSHE to record sleep and restactivity rhythms After completion of the baseline assessment patients will either be referred to the research nurse for commencement of the SRT protocol or provided with the SHE resource At 6 weeks and 3 months post-randomisation patients will be requested to complete the same battery of questionnaires as during the baseline assessment Following completion of the final study assessment 3 months post-randomisation those randomised to the SHE condition will be offered the opportunity to complete the SRT protocol without the requirement to complete any further assessments
Interventions Sleep Restriction Therapy SRT
SRT is a manualised adaptive behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase SRT will be delivered by trained research nurses
Sleep Hygiene Education SHE
SHE will be delivered via a booklet that provides information about lifestyle changes eg reducing exercise in the evening light snack before bedtime reducing caffeine and changes to the bedroom environment eg dark room comfortable mattress optimal room temperature Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period
Participants will be recruited from breast cancer results clinics in two study sites Our target population is newly diagnosed non-metastatic patients whose primary cancer treatment is surgery Participants will go through initial screening and will be sent an online participant information sheet and consent form Once consent form is signed marking enrolment in the study the second stage of screening will commence It involves assessing current sleep status based on diagnostic criteria for acute insomnia current psychiatric symptoms and review of other relevant medical information diagnosis of other sleep disorders other medical and psychiatric disorders This is to confirm the diagnosis of acute insomnia and establish that there are no medical or psychiatric conditions that might preclude someone from taking part in the study Once eligibility is ascertained patients will be randomly assigned to SRT or the SHE control group The investigators aim to randomise 50 patients n25 in each trial arm
After randomisation to SRT or SHE patients will be sent an email with a link to complete a baseline pre-intervention assessment of sleep fatigue and mental health Patients will also be required to complete the consensus sleep diary and wear an actigraphy device for 7 days prior to commencement of SRTSHE to record sleep and restactivity rhythms After completion of the baseline assessment patients will either be referred to the research nurse for commencement of the SRT protocol or provided with the SHE resource At 6 weeks and 3 months post-randomisation patients will be requested to complete the same battery of questionnaires as during the baseline assessment Following completion of the final study assessment 3 months post-randomisation those randomised to the SHE condition will be offered the opportunity to complete the SRT protocol without the requirement to complete any further assessments
Interventions Sleep Restriction Therapy SRT
SRT is a manualised adaptive behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase SRT will be delivered by trained research nurses
Sleep Hygiene Education SHE
SHE will be delivered via a booklet that provides information about lifestyle changes eg reducing exercise in the evening light snack before bedtime reducing caffeine and changes to the bedroom environment eg dark room comfortable mattress optimal room temperature Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None