Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Strathclyde
About this trial
The purpose of this trial is to evaluate an intervention designed to improve insomnia and sleep in people living with secondary breast cancer. The study will assess whether the intervention is feasible and acceptable to deliver and participate in, and whether it may improve sleep and related outcomes.
The main questions the study aims to answer are:
1. Is it feasible to recruit people with secondary breast cancer to take part in the trial?; 2. Is the intervention feasible for people with secondary breast cancer to use and complete?; 3. Is the intervention acceptable to participants?; 4. Does the intervention improve sleep, fatigue, quality of life, and mental health?;
Participants will be allocated to one of two groups:
1. Intervention group: Participants will be invited to attend five weekly sessions with a trained facilitator to receive the intervention. 2. Control group: Participants will receive a Sleep Hygiene Education self-help resource to use over a five-week period.
Participants will complete questionnaires, sleep diaries, and sleep monitoring using a wearable device at three time points: before treatment, immediately after the five-week treatment period, and three months after treatment.
Participants will also be invited to provide feedback about their experiences of taking part in the study and the intervention through either an interview or survey.
The results will be used to determine whether the intervention is feasible and acceptable and whether there is evidence of potential benefits for sleep and other outcomes. The findings will help determine whether further research of the intervention is warranted and if there is further intervention development work required.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of secondary breast cancer;
Have a prognosis of greater than 6 months;
Be aged 18 years or over;
Be willing and able to provide informed consent;
Disqualifiers
Report active suicidal ideation and/or recent suicide attempts (measured via item 9 of the Patient Health Questionnaire-9);
Are currently receiving, or have completed within the previous 6 months, CBTi or specific components (e.g., sleep restriction therapy, stimulus control, or cognitive therapy) delivered in a live or one-to-one format OR those who participated in the co-production workshop study to develop the intervention;
Individuals who are currently receiving inpatient hospital treatment, or who are scheduled for inpatient hospital admission during the study intervention period;
Individuals with severe pain that is poorly controlled and/or significantly interferes with the individual's ability to engage safely with the study intervention;
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep hygiene education
BehavioralParticipants in this group will receive a sleep hygiene education resource containing evidence-based advice regarding sleep habits, lifestyle factors, and sleep environment recommendations. Participants in the control condition will be asked to implement the advice over a 5-week period and will continue to complete sleep diaries, actigraphy monitoring, and outcome assessments at the same time points as the intervention group.
Cognitive behavioural therapy for insomnia (CBTi)
BehavioralThe intervention was developed by behavioural sleep medicine experts at the Strathclyde Sleep Centre in collaboration with individuals living with secondary breast cancer and healthcare professionals. The intervention is based on the core components of CBTi targeting the sleep-related behaviours and thoughts that contribute to the development and maintenance of insomnia that were specifically adapted for secondary breast cancer patients. Components include sleep education and sleep hygiene, sleep restriction therapy, stimulus control, relaxation strategies, and cognitive techniques. The intervention will be delivered in 5 weekly sessions, by the research team. The intervention programme includes an onboarding session, 4 weekly sessions, an optional individual check-in at week 3 and involved home-based practice of behavioural components.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Control group (SHE + TAU)Active comparator 1 intervention
Group B: Intervention group (CBTi + SHE + TAU)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant recruitment
Recruitment feasibility will be assessed using data collected through an online recruitment/sign-up form, which includes the Participant Information Sheet (PIS), eligibility screening questionnaire, informed consent form, and assessment questionnaire. Enrolment data for all participants who provide informed consent will be used to assess feasibility of recruitment. Recruitment will be considered feasible where 80% of target achieved. The form will also record the number of individuals who meet the eligibility criteria but do not enrol in the study after viewing the PIS and completing the screening questionnaire. Where provided, reasons for non-participation will also be recorded. This will allow recruitment rates and reasons for non-participation to be assessed.
Time frame
At completion of the recruitment period (up to 9 months after recruitment initiation)2
Participant retention
Retention will be assessed by determining the proportion of enrolled participants who remain in the study and complete all outcome assessments throughout the study period. A retention rate of at least 70% of enrolled participants will be considered the target.
Time frame
At 3-month follow-up3
Intervention fidelity - facilitator
Intervention fidelity will be assessed by examining facilitator adherence to the intervention protocol using a check-list. Facilitator adherence will be assessed in sampled sessions, with adherence defined as delivery of \>80% of the specified intervention content.
Time frame
1 year study period4
Intervention fidelity - participants
Participant engagement in the intervention group will be assessed by attendance at ≥2 of 4 intervention sessions (or review of session recordings) in the intervention group.
Time frame
During the intervention phase through immediately post-interventionSecondary outcomes
1
Change in insomnia severity
Insomnia Severity Index (ISI, Morin et al., 2011). The ISI is a 7-item measure that evaluates the severity of sleep disturbance during the past 2 weeks. Scores range from 0-21 with higher scores indicating greater insomnia severity.
Time frame
Baseline, immediately post-intervention, and 3-month follow-up2
Change in sleep outcomes
Data from sleep diaries and actigraphy.
Time frame
Baseline, immediately post-intervention, and 3-month follow-up3
Change in mental health [depression]
Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 (Kroenke, Spitzer \& Williams, 2001) is a 9-item validated measure for the use of identifying symptoms of depression based on the DSM-5 criteria. Scores range from 0-27, with a higher score indicating more severe depressive symptoms
Time frame
Baseline, immediately post-intervention, and 3-month follow-up4
Change in mental health [anxiety]
Generalised Anxiety Disorders - 7 (GAD-7). The GAD-7 (Spitzer, Kroenke \& Williams, 2006) is a 7-item which measures the presence and severity of anxiety symptoms with the use of some DSM-5 criteria for Generalised Anxiety Disorder. Scores range from 0-21, with a higher score indicating more severe anxiety symptoms.
Time frame
Baseline, immediately post-intervention, and 3-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Strathclyde
Lead sponsor
Beatson West of Scotland Cancer Centre
Collaborator
NHS Lothian
Collaborator
Source ClinicalTrials.gov
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