Cancer SurvivorsIN-FACT-0NCT06046573
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
A study testing Support and information, Behavioral activation and Systematic exposure with mindfulness training in people with Cancer Survivors and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors, Anxiety, Depression
- What is being tested?
- Support and information, Behavioral activation and Systematic exposure with mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2024to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
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.
- Conditions
- Cancer Survivors, Anxiety, Depression
- Being tested
- Support and information, Behavioral activation, Systematic exposure with mindfulness training, Promotion of health behaviors
- Keywords
- psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support and informationBehavioural
Emotional and technical support. Information about the long-term effects of cancer.
Behavioral activationBehavioural
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness trainingBehavioural
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Promotion of health behaviorsBehavioural
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered psychological treatment, arm #1 | Experimental | Support and information + Behavioral activation Receives: Behavioral: Support and information; Behavioral: Behavioral activation |
| Internet-delivered psychological treatment, arm #2 | Experimental | Support and information + Systematic exposure with mindfulness training Receives: Behavioral: Support and information; Behavioral: Systematic exposure with mindfulness training |
| Internet-delivered psychological treatment, arm #3 | Experimental | Support and information + Promotion of health behaviors Receives: Behavioral: Support and information; Behavioral: Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #4 | Experimental | Support and information + Behavioral activation + Systematic exposure with mindfulness training Receives: Behavioral: Support and information; Behavioral: Behavioral activation; Behavioral: Systematic exposure with mindfulness training |
| Internet-delivered psychological treatment, arm #5 | Experimental | Support and information + Behavioral activation + Promotion of health behaviors Receives: Behavioral: Support and information; Behavioral: Behavioral activation; Behavioral: Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #6 | Experimental | Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors Receives: Behavioral: Support and information; Behavioral: Systematic exposure with mindfulness training; Behavioral: Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #7 | Experimental | Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors Receives: Behavioral: Support and information; Behavioral: Behavioral activation; Behavioral: Systematic exposure with mindfulness training; Behavioral: Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #8 | Experimental | Support and information Receives: Behavioral: Support and information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 2 of treatment
Feasibility 3: Adherence to the treatment protocol #1
Number of modules initiated, as registered by the clinician.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: Post-treatment assessment (within 45 days after treatment)
Feasibility 8: Patients' satisfaction with the treatment #2
Likert items pertaining to satisfaction with components.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety).
Measured: 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.
Somatic Symptom Scale 8 (SSS-8, theoretical range: 0-32, where a higher score indicates a higher somatic symptom burden). Exploratory secondary analyses will be based on individual items, each scored 0-4.
Measured: 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.
Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress).
Measured: 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.
12-item WHO Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability).
Measured: 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
3-item Behavioral Activation for Depression Scale - Activation (BADS-AC-3, theoretical range: 0-18, where a higher score indicates a higher level of behavioral activation).
Measured: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Symptom preoccupation
Symptom Preoccupation Scale (preliminary scale). A higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an an item pool, and the scale is is under development, which means that the total range cannot be preregistered.
Measured: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Physical activity
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ, theoretical range 0-99, where a higher score indicates a higher level of physical activity). If necessary for statistical modeling, the GSLTPAQ will be dichotomized to indicate active (≥24) vs. insufficiently active (<24).
Measured: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Health-related self-efficacy.
Based loosely on the Arthritis Self-efficacy Scale. Theoretical range of 0-60, where a higher score indicates a higher level of general health-related self-efficacy.
Measured: 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).
Relationship with the therapist (therapeutic alliance)
Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
Measured: Week 2 of treatment
Screening only: Alcohol use
Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use).
Measured: At screening
Screening only: Substance use
Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use).
Measured: At screening
Screening only: General distress
Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Mar 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erland Axelsson, Karolinska Institutet
- Investigators
- Erland Axelsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046573
- Sponsor's protocol ID
- 2023-04056-01 #1
- Other IDs
- 2023
- Acronym
- IN-FACT-0
- Status last verified
- Dec 2024
- First submitted
- 6 Sep 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41136825
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
- ClinicalTrials.gov ID
- NCT06046573
- Acronym / sponsor ID
- IN-FACT-0 / 2023-04056-01 #1
- Conditions
- Cancer Survivors, Anxiety, Depression
- Keywords
- psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered psychological treatment, arm #1 | Experimental | Behavioral: Support and information, Behavioral: Behavioral activationSupport and information + Behavioral activation |
| Internet-delivered psychological treatment, arm #2 | Experimental | Behavioral: Support and information, Behavioral: Systematic exposure with mindfulness trainingSupport and information + Systematic exposure with mindfulness training |
| Internet-delivered psychological treatment, arm #3 | Experimental | Behavioral: Support and information, Behavioral: Promotion of health behaviorsSupport and information + Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #4 | Experimental | Behavioral: Support and information, Behavioral: Behavioral activation, Behavioral: Systematic exposure with mindfulness trainingSupport and information + Behavioral activation + Systematic exposure with mindfulness training |
| Internet-delivered psychological treatment, arm #5 | Experimental | Behavioral: Support and information, Behavioral: Behavioral activation, Behavioral: Promotion of health behaviorsSupport and information + Behavioral activation + Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #6 | Experimental | Behavioral: Support and information, Behavioral: Systematic exposure with mindfulness training, Behavioral: Promotion of health behaviorsSupport and information + Systematic exposure with mindfulness training + Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #7 | Experimental | Behavioral: Support and information, Behavioral: Behavioral activation, Behavioral: Systematic exposure with mindfulness training, Behavioral: Promotion of health behaviorsSupport and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors |
| Internet-delivered psychological treatment, arm #8 | Experimental | Behavioral: Support and informationSupport and information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support and informationEmotional and technical support. Information about the long-term effects of cancer. | Behavioural | Internet-delivered psychological treatment, arm #1, Internet-delivered psychological treatment, arm #2, Internet-delivered psychological treatment, arm #3, Internet-delivered psychological treatment, arm #4, Internet-delivered psychological treatment, arm #5, Internet-delivered psychological treatment, arm #6, Internet-delivered psychological treatment, arm #7, Internet-delivered psychological treatment, arm #8 |
| Behavioral activationBehavioral activation with existential themes and emphasis on values and relationships. | Behavioural | Internet-delivered psychological treatment, arm #1, Internet-delivered psychological treatment, arm #4, Internet-delivered psychological treatment, arm #5, Internet-delivered psychological treatment, arm #7 |
| Systematic exposure with mindfulness trainingSystematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma. | Behavioural | Internet-delivered psychological treatment, arm #2, Internet-delivered psychological treatment, arm #4, Internet-delivered psychological treatment, arm #6, Internet-delivered psychological treatment, arm #7 |
| Promotion of health behaviorsAn overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep. | Behavioural | Internet-delivered psychological treatment, arm #3, Internet-delivered psychological treatment, arm #5, Internet-delivered psychological treatment, arm #6, Internet-delivered psychological treatment, arm #7 |
Primary outcome
Feasibility 1: Feasibility of the randomized factorial design
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
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.
Feasibility 2: Credibility of the treatment as perceived by patients
Time frame: Week 2 of treatment
Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.
Feasibility 3: Adherence to the treatment protocol #1
Time frame: Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
Number of modules initiated, as registered by the clinician.
Feasibility 4: Adherence to the treatment protocol #2
Time frame: Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
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.
Feasibility 5: Acceptability of the online measurement strategy #1
Time frame: Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
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.
Feasibility 6: Acceptability of the online measurement strategy #2
Time frame: Post-treatment assessment (within 45 days after treatment)
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").
Feasibility 7: Patients' satisfaction with the treatment #1
Time frame: Post-treatment assessment (within 45 days after treatment)
The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.
Feasibility 8: Patients' satisfaction with the treatment #2
Time frame: Post-treatment assessment (within 45 days after treatment)
Likert items pertaining to satisfaction with components.
Feasibility 9: Rate of adverse events and negative experiences #1
Time frame: Post-treatment assessment (within 45 days after treatment)
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
Feasibility 10: Rate of adverse events and negative experiences #2
Time frame: Post-treatment assessment (within 45 days after treatment)
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.
Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety
Time frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms
Time frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)
Feasibility 13: Preliminary efficacy in terms of within-group improvement in the fear of cancer recurrence
Time frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
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)
Feasibility 14: Preliminary efficacy in terms of within-group improvement in health-related quality of life
Time frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
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)
12 secondary outcomes
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Health anxiety.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Symptom preoccupation
Time frame: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Physical activity
Time frame: 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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Health-related self-efficacy.
Time frame: 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).
Relationship with the therapist (therapeutic alliance)
Time frame: Week 2 of treatment
Screening only: Alcohol use
Time frame: At screening
Screening only: Substance use
Time frame: At screening
Screening only: General distress
Time frame: At screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 41136825Winter 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erland Axelsson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support and information, Behavioral activation and Systematic exposure with mindfulness training in people with Cancer Survivors and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility 1: Feasibility of the randomized factorial design (time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.