Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
IN-FACT-0
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
March 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2024
CompletedDecember 16, 2024
December 1, 2024
8 months
September 6, 2023
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Feasibility 1: Feasibility of the randomized factorial design
A key feasibility outcome of this pilot study is the overall experience of study administrators and therapists tasked with the assignment and delivery of treatment variants in accordance with the randomized factorial design. After the main phase, all study administrators and therapists will be asked to rate the feasibility of the planned study design from 0 ("not feasible at all") to 10 ("fully feasible"), which will reported as a mean (SD) and median.
Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 2: Credibility of the treatment as perceived by patients
Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.
Week 2 of treatment
Feasibility 3: Adherence to the treatment protocol #1
Number of modules initiated, as registered by the clinician.
Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
Feasibility 4: Adherence to the treatment protocol #2
Number of completed exercises, as based on a short weekly questionnaire tailored to suit each treatment arm, with corresponding questions about the number of days devoted to exposure exercises, days devoted to activity planning, and days devoted to the promotion of health behaviors.
Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 5: Acceptability of the online measurement strategy #1
Number of measurements completed at each measurement point after the pre-treatment assessment. Preregistered target: at least 70% non-missing at the post-treatment and follow-up assessments.
Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
Feasibility 6: Acceptability of the online measurement strategy #2
Perceived strain caused by the measurement strategy. Preregistered target: at least 75% with a rating below 7 from 0 ("not at all stressful/distressing") to 10 ("extremely stressful/distressing").
Post-treatment assessment (within 45 days after treatment)
Feasibility 7: Patients' satisfaction with the treatment #1
The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.
Post-treatment assessment (within 45 days after treatment)
Feasibility 8: Patients' satisfaction with the treatment #2
Likert items pertaining to satisfaction with components.
Post-treatment assessment (within 45 days after treatment)
Feasibility 9: Rate of adverse events and negative experiences #1
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
Post-treatment assessment (within 45 days after treatment)
Feasibility 10: Rate of adverse events and negative experiences #2
20-item Negative Effects Questionnaire (NEQ-20). This will be reported as the proportion of endorsed items in the following subdomains: increase in symptoms, perceived insufficient quality of treatment, dependency, stigma, and hopelessness.
Post-treatment assessment (within 45 days after treatment)
Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)
Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 13: Preliminary efficacy in terms of within-group improvement in the fear of cancer recurrence
9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence)
Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 14: Preliminary efficacy in terms of within-group improvement in health-related quality of life
36-item Short Form Health Survey (SF-36, scored as a Mental Health Component Score and a Physical Health Component Score according to standard norms, both with a theoretical range of 0-100, where a higher score indicates a higher health-related quality of life)
Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary Outcomes (12)
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Health anxiety.
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.
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Somatic symptom burden.
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.
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Body image distress.
Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days).
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Disability.
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.
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Behavioral activation
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).
- +7 more secondary outcomes
Study Arms (8)
Internet-delivered psychological treatment, arm #1
EXPERIMENTALSupport and information + Behavioral activation
Internet-delivered psychological treatment, arm #2
EXPERIMENTALSupport and information + Systematic exposure with mindfulness training
Internet-delivered psychological treatment, arm #3
EXPERIMENTALSupport and information + Promotion of health behaviors
Internet-delivered psychological treatment, arm #4
EXPERIMENTALSupport and information + Behavioral activation + Systematic exposure with mindfulness training
Internet-delivered psychological treatment, arm #5
EXPERIMENTALSupport and information + Behavioral activation + Promotion of health behaviors
Internet-delivered psychological treatment, arm #6
EXPERIMENTALSupport and information + Systematic exposure with mindfulness training + Promotion of health behaviors
Internet-delivered psychological treatment, arm #7
EXPERIMENTALSupport and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors
Internet-delivered psychological treatment, arm #8
EXPERIMENTALSupport and information
Interventions
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet
Stockholm, Sweden
Related Publications (1)
Winter J, Gasslander N, Rane G, Sundstrom F, Bjorkhem-Bergman L, Hedman C, Axelsson E. Proof-of-concept for a randomized factorial design strategy to build a complex online support program for cancer survivors with psychiatric symptoms: the IN-FACT-0 feasibility trial. J Cancer Surviv. 2025 Oct 25. doi: 10.1007/s11764-025-01905-2. Online ahead of print.
PMID: 41136825DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erland Axelsson, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 21, 2023
Study Start
March 10, 2024
Primary Completion
October 22, 2024
Study Completion
October 22, 2024
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
Individual participant data from this pilot study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis.