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Cancer SurvivorsIN-FACT-1NCT06046586

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteSweden
Study dates
10 Apr 2025to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • 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

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. Contact the study team or a site near you to ask about taking part.

Erland Axelsson, PhD contact

0706171039 ext. +46

erland.axelsson@ki.se

Sweden1 site, 1 recruiting

  • Karolinska Institutet

    Stockholm

    Erland Axelsson, +46 70 617 10 39, erland.axelsson@ki.se

    Recruiting

Other trials in Sweden

About this study

Official title: Randomized Factorial Trial 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 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.

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 groups in NCT06046586
Study groupRoleWhat they receive
Internet-delivered psychological treatment, arm #1ExperimentalSupport and information + Behavioral activation
Receives: Behavioral: Support and information; Behavioral: Behavioral activation
Internet-delivered psychological treatment, arm #2ExperimentalSupport and information + Systematic exposure with mindfulness training
Receives: Behavioral: Support and information; Behavioral: Systematic exposure with mindfulness training
Internet-delivered psychological treatment, arm #3ExperimentalSupport and information + Promotion of health behaviors
Receives: Behavioral: Support and information; Behavioral: Promotion of health behaviors
Internet-delivered psychological treatment, arm #4ExperimentalSupport 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 #5ExperimentalSupport 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 #6ExperimentalSupport 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 #7ExperimentalSupport 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 #8ExperimentalSupport and information
Receives: Behavioral: Support and information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General anxiety

    General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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).

  2. Depressive symptoms

    Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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).

  3. 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). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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 outcomes (10)

  1. Health anxiety

    14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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).

  2. 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. This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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).

  3. 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 90 days)

  4. Disability

    12-item World Health Organization Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.

    Measured: 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).

  5. Treatment credibility and patient expectancy of improvement

    Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy)

    Measured: Week 2 of treatment

  6. 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

  7. Patient satisfaction with treatment

    8-item Client satisfaction questionnaire (CSQ-8, theoretical range: 8-32, where a higher score indicates higher satisfaction with treatment)

    Measured: Post-treatment assessment (immediately after treatment, completed within 90 days)

  8. Adverse events

    Brief questionnaire with three free-text items, each of which can be used to report an adverse event. For each adverse event, a rating is given of initial negative impact, and negative impact at post-treatment, on a scale from 0: "not at all", to 3: "very negatively". Reported primarily in terms of the number of participants reporting at least one adverse event.

    Measured: Post-treatment assessment (immediately after treatment, completed within 90 days)

  9. Perceived negative effects of 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.

    Measured: Post-treatment assessment (immediately after treatment, completed within 90 days)

  10. Lifestyle behaviors

    Lifestyle Behaviors Questionnaire (LBQ). The LBQ comprises 11 items that cover tobacco use, alcohol use, physical activity and diet. Dichotomous risky lifestyle behavior variables will be derived from the LBQ in terms of: "At least one unhealthy lifestyle behavior", "Daily smoking", "Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week", "Insufficient physical activity, less than 150 minutes/week", and "Notably unhealthy dietary habits (diet index 0-4)". Risky lifestyle behavior will be defined as daily smoking, binge drinking of 4/5 (women/men) drinks at one occasion more than once a month and/or more than 9/14 (women/men) standard glasses of alcohol weekly, insufficient physical activity (<150 minutes/week) or significantly unhealthy diet habits (a score of 0-4 on a diet index in the questionnaire, ranging from 0-12).

    Measured: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start10 Apr 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046586
Sponsor's protocol ID
2023-04056-01 #2
Other IDs
2023
Acronym
IN-FACT-1
Status last verified
Sep 2026
First submitted
6 Sep 2023
Last updated
9 Sep 2026
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.

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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erland Axelsson, PhD (0706171039 ext. +46, erland.axelsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 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 NCT06046586.

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 9 Sep 2026.

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