Insomnia is a sleep disorder characterised by persistent difficulties in initiating sleep, maintaining sleep during the night, or achieving restful sleep. These difficulties arise even in the presence of adequate sleeping conditions and are often associated with daytime sleepiness, memory and attention deficits, irritability, fatigue and reduced performance in daily activities. To be clinically significant, it must occur at least three times a week for three consecutive months and significantly compromise the person’s quality of life. Although common in the general population, insomnia is more prevalent and severe in individuals with a history of cancer, affecting between 29% and 64% even after the end of primary cancer treatment. Its origin is multifactorial, involving pain, fatigue, hormonal changes, anxiety, worry about the progression of the disease and behavioural changes acquired during the oncological process. When chronic, it is associated with significant adverse consequences, such as worsening fatigue, persistent cognitive deficits, psychological distress, immune dysfunction and deterioration in quality of life. It can also interfere with recovery, jeopardise the response to treatment and increase the risk of the disease recurring.
Home / Publications / Publication
Home / Publications / Publication
A DIGITAL INTERVENTION FOR INSOMNIA IN ONCOLOGY
Publication type: Article Summary
Original title: Digital Cognitive-Behavioral Therapy for Insomnia in Cancer Survivors: Protocol for a Pragmatic Clinical Trial
Article publication date: October 2024
Source: Acta Médica Portuguesa
Authors: Maria Clara, Annemieke Straten, Maria Canavarro & Ana Gomes
What is the goal, target audience, and areas of digital health it addresses?
The study aims to evaluate the clinical efficacy and acceptability of OncoSleep, a digital intervention based on cognitive-behavioural therapy (CBT) for insomnia, developed to meet the needs of individuals with a history of cancer who experience sleep disturbances after medical treatment. The target audience is adults aged 18 or over, with a previous diagnosis of solid or haematological tumours who have completed primary oncological treatment and have persistent symptoms of insomnia, even in the absence of a clinical diagnosis. The study falls within the areas of digital health, with special emphasis on psycho-oncology, behavioural medicine and telepsychology.
What is the context?
Insomnia is a sleep disorder characterised by persistent difficulties in initiating sleep, maintaining sleep during the night, or achieving restful sleep. These difficulties arise even in the presence of adequate sleeping conditions and are often associated with daytime sleepiness, memory and attention deficits, irritability, fatigue and reduced performance in daily activities. To be clinically significant, it must occur at least three times a week for three consecutive months and significantly compromise the person’s quality of life.
Although common in the general population, insomnia is more prevalent and severe in individuals with a history of cancer, affecting between 29% and 64% even after the end of primary cancer treatment. Its origin is multifactorial, involving pain, fatigue, hormonal changes, anxiety, worry about the progression of the disease and behavioural changes acquired during the oncological process. When chronic, it is associated with significant adverse consequences, such as worsening fatigue, persistent cognitive deficits, psychological distress, immune dysfunction and deterioration in quality of life. It can also interfere with recovery, jeopardise the response to treatment and increase the risk of the disease recurring.
Despite its clinical relevance, insomnia is often undervalued in post-oncological care. It is therefore essential to implement structured and accessible therapeutic approaches capable of providing an effective response to this neglected need.
What are the current approaches?
Currently, international clinical guidelines recommend CBT as a first-line treatment for insomnia, including post-oncological care, due to its proven efficacy and safety profile. This evidence-based psychotherapeutic approach helps identify and modify dysfunctional thoughts and behaviours. In insomnia, CBT has shown consistent improvements in several sleep parameters, such as onset latency (time needed to fall asleep), efficiency and total sleep duration, as well as secondary benefits such as reduced fatigue, daytime sleepiness and negative perception of quality of life.
Despite its effectiveness, the implementation of CBT in clinical practice is limited by the shortage of specialized professionals, the time and resources required for face-to-face protocols, and patients’ physical or cognitive limitations. Consequently, pharmacotherapy remains the most widely used approach, despite offering only temporary benefits and a higher risk of adverse effects.
CBT-based digital interventions for insomnia offer greater scalability, personalization, and greater user autonomy, but still face challenges such as reduced adherence in the absence of support, inequality in access, lack of regulation, and the need for more clinical evidence. The training of professionals for remote monitoring is also essential for the success of these interventions.
What does innovation consist of? How is the impact of this study assessed?
OncoSleep is a CBT-based digital intervention for insomnia, designed to be self-administered but with clinical support, making it an accessible option tailored to the needs of individuals with a history of cancer. The program lasted six weeks, with weekly sessions of approximately 35 minutes, delivered through a secure digital platform.
Each module combined personalised interactive content — such as explanatory videos, practical exercises and self-registration tasks — with cognitive and behavioural strategies tailored to each user’s profile. Before each session, participants answered a brief questionnaire on sleep parameters, emotional state and fulfilment of previous recommendations. The answers allowed the platform to adapt the following content and generate individualised recommendations, based on continuous monitoring of indicators such as latency to fall asleep, number of awakenings, time awake after sleep onset, total sleep duration, time in bed, efficiency (percentage of time slept), perceived quality and level of rest on awakening.
All the data entered was automatically recorded and analysed weekly by a psychologist, who monitored each user’s progress remotely. Whenever necessary, the professional made contact via written messages on the platform itself, providing personalised support, clarifying doubts or reinforcing therapeutic strategies.
The impact of this study was assessed at two points: at the start and at the end of the programme. The primary outcome was insomnia severity, measured by the Insomnia Severity Index. Secondary outcomes included the assessment of fatigue (Multidimensional Fatigue Symptom Inventory – Short Form), psychological distress (Hospital Anxiety and Depression Scale), and quality of life (WHOQOL-BREF and EORTC QLQ-C30). The acceptability of the intervention was analysed at the end of the programme based on quantitative questionnaires — satisfaction, perceived usefulness, usability of the platform and intention to use it in the future — complemented by an open question that collected comments and suggestions from the participants.
What are the expected results?
Although still without results, the OncoSleep program is expected to improve sleep quality, reduce fatigue and relieve emotional symptoms in individuals with a history of oncological disease. Its structured design, based on CBT and accessible through a secure digital platform, aims to promote adherence throughout the intervention weeks. By combining flexibility with remote clinical follow-up, OncoSleep positions itself as a scalable, cost-effective solution adapted to the needs of the post-treatment period. In the medium term, it may contribute to greater autonomy of users, better quality of life and reduction of the burden on health services.
Would you like to know all the details?
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Home / Publications / Publication
A DIGITAL INTERVENTION FOR INSOMNIA IN ONCOLOGY
Publication type: Article Summary
Original title: Digital Cognitive-Behavioral Therapy for Insomnia in Cancer Survivors: Protocol for a Pragmatic Clinical Trial
Article publication date: October 2024
Source: Acta Médica Portuguesa
Authors: Maria Clara, Annemieke Straten, Maria Canavarro & Ana Gomes
What is the goal, target audience, and areas of digital health it addresses?
The study aims to evaluate the clinical efficacy and acceptability of OncoSleep, a digital intervention based on cognitive-behavioural therapy (CBT) for insomnia, developed to meet the needs of individuals with a history of cancer who experience sleep disturbances after medical treatment. The target audience is adults aged 18 or over, with a previous diagnosis of solid or haematological tumours who have completed primary oncological treatment and have persistent symptoms of insomnia, even in the absence of a clinical diagnosis. The study falls within the areas of digital health, with special emphasis on psycho-oncology, behavioural medicine and telepsychology.
What is the context?
Insomnia is a sleep disorder characterised by persistent difficulties in initiating sleep, maintaining sleep during the night, or achieving restful sleep. These difficulties arise even in the presence of adequate sleeping conditions and are often associated with daytime sleepiness, memory and attention deficits, irritability, fatigue and reduced performance in daily activities. To be clinically significant, it must occur at least three times a week for three consecutive months and significantly compromise the person’s quality of life.
Although common in the general population, insomnia is more prevalent and severe in individuals with a history of cancer, affecting between 29% and 64% even after the end of primary cancer treatment. Its origin is multifactorial, involving pain, fatigue, hormonal changes, anxiety, worry about the progression of the disease and behavioural changes acquired during the oncological process. When chronic, it is associated with significant adverse consequences, such as worsening fatigue, persistent cognitive deficits, psychological distress, immune dysfunction and deterioration in quality of life. It can also interfere with recovery, jeopardise the response to treatment and increase the risk of the disease recurring.
Despite its clinical relevance, insomnia is often undervalued in post-oncological care. It is therefore essential to implement structured and accessible therapeutic approaches capable of providing an effective response to this neglected need.
What are the current approaches?
Currently, international clinical guidelines recommend CBT as a first-line treatment for insomnia, including post-oncological care, due to its proven efficacy and safety profile. This evidence-based psychotherapeutic approach helps identify and modify dysfunctional thoughts and behaviours. In insomnia, CBT has shown consistent improvements in several sleep parameters, such as onset latency (time needed to fall asleep), efficiency and total sleep duration, as well as secondary benefits such as reduced fatigue, daytime sleepiness and negative perception of quality of life.
Despite its effectiveness, the implementation of CBT in clinical practice is limited by the shortage of specialized professionals, the time and resources required for face-to-face protocols, and patients’ physical or cognitive limitations. Consequently, pharmacotherapy remains the most widely used approach, despite offering only temporary benefits and a higher risk of adverse effects.
CBT-based digital interventions for insomnia offer greater scalability, personalization, and greater user autonomy, but still face challenges such as reduced adherence in the absence of support, inequality in access, lack of regulation, and the need for more clinical evidence. The training of professionals for remote monitoring is also essential for the success of these interventions.
What does innovation consist of? How is the impact of this study assessed?
OncoSleep is a CBT-based digital intervention for insomnia, designed to be self-administered but with clinical support, making it an accessible option tailored to the needs of individuals with a history of cancer. The program lasted six weeks, with weekly sessions of approximately 35 minutes, delivered through a secure digital platform.
Each module combined personalised interactive content — such as explanatory videos, practical exercises and self-registration tasks — with cognitive and behavioural strategies tailored to each user’s profile. Before each session, participants answered a brief questionnaire on sleep parameters, emotional state and fulfilment of previous recommendations. The answers allowed the platform to adapt the following content and generate individualised recommendations, based on continuous monitoring of indicators such as latency to fall asleep, number of awakenings, time awake after sleep onset, total sleep duration, time in bed, efficiency (percentage of time slept), perceived quality and level of rest on awakening.
All the data entered was automatically recorded and analysed weekly by a psychologist, who monitored each user’s progress remotely. Whenever necessary, the professional made contact via written messages on the platform itself, providing personalised support, clarifying doubts or reinforcing therapeutic strategies.
The impact of this study was assessed at two points: at the start and at the end of the programme. The primary outcome was insomnia severity, measured by the Insomnia Severity Index. Secondary outcomes included the assessment of fatigue (Multidimensional Fatigue Symptom Inventory – Short Form), psychological distress (Hospital Anxiety and Depression Scale), and quality of life (WHOQOL-BREF and EORTC QLQ-C30). The acceptability of the intervention was analysed at the end of the programme based on quantitative questionnaires — satisfaction, perceived usefulness, usability of the platform and intention to use it in the future — complemented by an open question that collected comments and suggestions from the participants.
What are the expected results?
Although still without results, the OncoSleep program is expected to improve sleep quality, reduce fatigue and relieve emotional symptoms in individuals with a history of oncological disease. Its structured design, based on CBT and accessible through a secure digital platform, aims to promote adherence throughout the intervention weeks. By combining flexibility with remote clinical follow-up, OncoSleep positions itself as a scalable, cost-effective solution adapted to the needs of the post-treatment period. In the medium term, it may contribute to greater autonomy of users, better quality of life and reduction of the burden on health services.
Would you like to know all the details?
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Multiple Sclerosis is known as a chronic disease of the central nervous system, with a wide variety of motor and sensory symptoms that can lead to work disability, socioeconomic burden, and reduced quality of life…
Neurosurgery Teleconsultation Wins Innovation Award
The aim of the BI Award for Innovation in Healthcare is to recognize innovative projects in the healthcare sector that improve the quality of life for the Portuguese people. In 2021, the specific theme was…
HealthData@PT: New SPMS Initiative for Health Data
Action HealthData@PT is launched in the context of the implementation of the European Health Data Space, and is an initiative approved by the European Commission under the EU4Health 2021-2027 programme. This initiative contributes to the…
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