Internet-Delivered Psychological Treatment for Cancer Survivors

Official title

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

Overview

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.

Interventions

• Behavioral Support and information
  Emotional and technical support. Information about the long-term effects of cancer.
• Behavioral Behavioral activation
  Behavioral activation with existential themes and emphasis on values and relationships.
• Behavioral 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.
• Behavioral Promotion of health behaviors
  An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Primary outcome measures

• General anxiety [Time frame: 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 [Time frame: 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 [Time frame: 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).]

Secondary outcome measures (10)

• Health anxiety [Time frame: 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 [Time frame: 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 [Time frame: Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days)]
• Disability [Time frame: 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 [Time frame: Week 2 of treatment]
• Relationship with the therapist (therapeutic alliance) [Time frame: Week 2 of treatment]
• Patient satisfaction with treatment [Time frame: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Adverse events [Time frame: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Perceived negative effects of treatment [Time frame: Post-treatment assessment (immediately after treatment, completed within 90 days)]
• Lifestyle behaviors [Time frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Karolinska Institutet — Stockholm

Identifiers

NCT: NCT06046586 · 2023-04056-01 #2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗