Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-0)
Status
Conditions
Treatments
Details and patient eligibility
About
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 factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Cancer survivor at least 0.5 years after main therapy. Survivor of breast cancer (n=24), testicular cancer (n=12), or thyroid cancer (n=12).
- 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 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 8 patient groups
Trial contacts and locations
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Central trial contact
Erland Axelsson, PhD
Data sourced from clinicaltrials.gov
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