Internet-Delivered Psychological Treatment for Cancer Survivors

Официальное название

Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Обзор

Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this randomized factorial trial at Karolinska Institutet, Stockholm, Sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. The aim is to determine the contribution of treatment components to the overall effect.

Вмешательства

• Поведенческое Support and information
  Emotional and technical support. Information about the long-term effects of cancer.
• Поведенческое Behavioral activation
  Behavioral activation with existential themes and emphasis on values and relationships.
• Поведенческое Systematic exposure with mindfulness training
  Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
• Поведенческое Promotion of health behaviors
  An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Первичные конечные точки

• General anxiety [Срок оценки: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]
• Depressive symptoms [Срок оценки: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]
• Fear of cancer recurrence [Срок оценки: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]

Вторичные конечные точки (10)

• Health anxiety [Срок оценки: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]
• Somatic symptom burden [Срок оценки: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]
• Body image distress [Срок оценки: Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days)]
• Disability [Срок оценки: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).]
• Treatment credibility and patient expectancy of improvement [Срок оценки: Week 2 of treatment]
• Relationship with the therapist (therapeutic alliance) [Срок оценки: Week 2 of treatment]
• Patient satisfaction with treatment [Срок оценки: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Adverse events [Срок оценки: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Perceived negative effects of treatment [Срок оценки: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Lifestyle behaviors [Срок оценки: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days).]

Критерии участия

Критерии включения

• Cancer survivor at least 0.5 years after main therapy
• Clinically significant anxiety or depression (Patient Health Questionnaire 9 \[PHQ-9\]≥10, or Generalized Anxiety Disorder 7 \[GAD-7\]≥8, or 9-item Fear of Cancer Recurrence Inventory \[FCRI-9\]≥16)
• At least 18 years old
• Resident of Region Stockholms, Västra Götalandsregionen, or Region Skåne, Sweden (listed and de facto)
• Sufficient technical knowledge and knowledge of the Swedish language to take part in a text-based online treatment
• Continuous access to an electronic device that can be used to access the study web platform

Критерии исключения

• Recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) item 9
• Severe medical condition (e.g., very poor prognosis, stage IV cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible
• Other ongoing psychological treatment
• Continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period
• Planned absence for more than one week of the intended treatment period
• No complete the pre-treatment assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Karolinska Institutet — Stockholm

Идентификаторы

NCT: NCT06046586 · 2023-04056-01 #2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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