ACTION: Addressing Cancer Treatment-related Insomnia Online in Newfoundland and Labrador

For cancer survivors, two of the biggest barriers to resuming normal functioning are cognitive impairment and insomnia. Approximately 75% of cancer patients report a decline in a variety of cognitive domains during cancer treatment, and up to 35% continue to experience cognitive difficulties for months or years post-treatment. Sleep disturbances affect 30-50% of individuals who have been treated for cancer and can have a negative effect on cancer recovery and overall quality of life. This research is investigating if online treatment for insomnia can improve memory, concentration, and attention in cancer survivors.


We are looking to recruit 162 cancer survivors who currently report problems with sleep AND difficulties paying attention, concentrating, and/or remembering things.


You may be eligible to participate if you meet the following criteria: 


For individuals without hematology malignancies:

  • You are easily able to understand and read English
  • No current evidence of cancer or clinically stable/inactive disease
  • You received chemotherapy and/or radiation at least 12 months prior to study entry 
  • You report problems with memory, concentration, or attention
  • You report difficulty falling asleep or staying asleep that impacts your ability to function during the day
  • You are able to care for yourself (good walking ability, physical ability)
  • You have high-speed internet connection and a webcam* and are fluent using the internet


For individuals with hematology malignancies:

  • You are easily able to understand and read English
  • You have a diagnosis of a hematological malignancy currently in remission
  • You completed cancer treatments including transplant, chemotherapy and/or immunotherapy at least 12 months prior to study entry
  • You report problems with memory, concentration, or attention
  • You report difficulty falling asleep or staying asleep that impacts your ability to function during the day
  • You are able to care for yourself (good walking ability, physical ability)
  • You have high-speed internet connection, webcam*, and are fluent using the internet


*If you are interested and meet all criteria but do not feel comfortable using a webcam or the internet please speak to us about other options.   


You may not be eligible to participate if: 


For individuals with and without hematological malignancies:

  • You have another sleep disorder, besides insomnia, that is not adequately treated (ie: untreated obstructive sleep, sleep apnea)
  • You have another psychological disorder that is not currently stable and/or would impair the ability to participate in the study
  • You have a major sensory deficit (e.g. blindness)
  • You have a neurologic or major medical condition known to affect cognitive function (e.g., Parkinson’s)
  • You have a history of cranial radiation
  • You have a history of any other condition that may affect cognitive functioning (e.g., traumatic brain injury)
  • You have previous experience with CBT-I
  • You are considering the potential for prescription of medications to help with sleep


* You will not be excluded for using psychotropic medication prior to study entry (e.g. antidepressants) provided that the dose was not recently altered (stable over the previous 6 weeks).  
 

What Does This Study Involve?

Online Cognitive Behavior Therapy for Insomnia (CBT-I) is a multicomponent treatment designed to address behaviors and thoughts that are known to influence the development and maintenance of sleep difficulties. You will receive seven individual sessions of CBT-I delivered by via video-conferencing over the course of eight weeks. 


Participation in this study also involves completing assessments that involve some questionnaires and performance tasks. The questionnaires will assess your sleep, your ability to remember things, pay attention, concentrate, and your psychological wellbeing. We will also ask about the impact of your insomnia on your ability to work, your mood, and energy levels, and your ability to remember things, pay attention, and concentrate. The performance tasks will assess your ability to learn and remember things. This will involve recalling and repeating a series of words, numbers, and other similar tasks


This study has 2 groups. You will be told which group you are in. We will use a computer to assign you to one of the study groups. It means that your doctor or the research team will not choose, and you cannot choose, which study group you are in. You will be put into a group by chance. You will have a 50% chance of being in Group 1 or 2. If you are in group 1, you will receive immediate treatment with online CBT-I. You will complete 5 assessments over an 8-month period. The assessments will take place: (a) before treatment, (b) halfway through treatment, (c) immediately following treatment, (d) 3 months after treatment, and (e) 6 months after treatment. There will be about 81 people in this group. If you are in group 2, you will receive treatment with online CBT-I after a waiting period of two months, during this period you will be monitored and still required to complete some assessments. You will complete 7 assessments over a 10-month period. The assessments will take place: (a) at study entrance, (b) after a one-month monitoring period, (c) before treatment, (d) halfway through treatment, (e) immediately following treatment, (f) 3 months after treatment, and (g) 6 months after treatment. There will be about 81 people in this group. 


If you are interested in this study, or unsure of whether you are eligible, please contact us at sleeplab@mun.ca so we can help you decide whether participation is right for you.


  

** WE ARE CURRENTLY LOOKING FOR PARTICIPANTS**

Investigators

Primary Investigator at Memorial University:

 Sheila N. Garland, PhD 

(Department of Psychology, Faculty of Science and Division of Oncology, Faculty of Medicine)


  

Co-Investigators:

Kara Laing, MD, FRCPC (Division of Oncology, Faculty of Medicine)

Joshua Rash, PhD, (Department of Psychology, Faculty of Science)

Melanie Seal, MD, FRCPC (Division of Oncology, Faculty of Medicine)

John Thoms, MD, FRCPC (Division of Oncology, Faculty of Medicine)

Josée Savard, PhD, (Département d'école de psychologie, Université Laval)

Veerabhadra Gadag, PhD, (Department of Biostatistics, Faculty of Medicine)


Supported by a grant from the Canadian Institutes of Health Research (CIHR)