Clinical trial NCT06046573: Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
Official title: Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Anxiety
Depression
Keywords: psycho-oncology
randomized factorial trial
Internet-delivered cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility 1: Feasibility of the randomized factorial design
timeFrame: Post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 2: Credibility of the treatment as perceived by patients
timeFrame: Week 2 of treatment
measure: Feasibility 3: Adherence to the treatment protocol #1
timeFrame: Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
measure: Feasibility 4: Adherence to the treatment protocol #2
timeFrame: Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 5: Acceptability of the online measurement strategy #1
timeFrame: Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
measure: Feasibility 6: Acceptability of the online measurement strategy #2
timeFrame: Post-treatment assessment (within 45 days after treatment)
measure: Feasibility 7: Patients' satisfaction with the treatment #1
timeFrame: Post-treatment assessment (within 45 days after treatment)
measure: Feasibility 8: Patients' satisfaction with the treatment #2
timeFrame: Post-treatment assessment (within 45 days after treatment)
measure: Feasibility 9: Rate of adverse events and negative experiences #1
timeFrame: Post-treatment assessment (within 45 days after treatment)
measure: Feasibility 10: Rate of adverse events and negative experiences #2
timeFrame: Post-treatment assessment (within 45 days after treatment)
measure: Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 13: Preliminary efficacy in terms of within-group improvement in the fear of cancer recurrence
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
measure: Feasibility 14: Preliminary efficacy in terms of within-group improvement in health-related quality of life
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary outcomes:
measure: Symptom domains surveyed primarily to assess the feasibility of the measurement method: Health anxiety.
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
measure: Symptom domains surveyed primarily to assess the feasibility of the measurement method: Somatic symptom burden.
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
measure: Symptom domains surveyed primarily to assess the feasibility of the measurement method: Body image distress.
timeFrame: Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days).
measure: Symptom domains surveyed primarily to assess the feasibility of the measurement method: Disability.
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
measure: Process and target variables surveyed primarily to assess the feasibility of the measurement method: Behavioral activation
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).
measure: Process and target variables surveyed primarily to assess the feasibility of the measurement method: Symptom preoccupation
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).
measure: Process and target variables surveyed primarily to assess the feasibility of the measurement method: Physical activity
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).
measure: Process and target variables surveyed primarily to assess the feasibility of the measurement method: Health-related self-efficacy.
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days).
measure: Relationship with the therapist (therapeutic alliance)
timeFrame: Week 2 of treatment
measure: Screening only: Alcohol use
timeFrame: At screening
measure: Screening only: Substance use
timeFrame: At screening
measure: Screening only: General distress
timeFrame: At screening
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erland Axelsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: