Internet-Delivered Psychological Treatment for Cancer Survivors

NCT ID: NCT06046586

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-10

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Survivors Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Internet-delivered psychological treatment, arm #1

Support and information + Behavioral activation

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Behavioral activation

Intervention Type BEHAVIORAL

Behavioral activation with existential themes and emphasis on values and relationships.

Internet-delivered psychological treatment, arm #2

Support and information + Systematic exposure with mindfulness training

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Systematic exposure with mindfulness training

Intervention Type BEHAVIORAL

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Internet-delivered psychological treatment, arm #3

Support and information + Promotion of health behaviors

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Promotion of health behaviors

Intervention Type BEHAVIORAL

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Internet-delivered psychological treatment, arm #4

Support and information + Behavioral activation + Systematic exposure with mindfulness training

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Behavioral activation

Intervention Type BEHAVIORAL

Behavioral activation with existential themes and emphasis on values and relationships.

Systematic exposure with mindfulness training

Intervention Type BEHAVIORAL

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Internet-delivered psychological treatment, arm #5

Support and information + Behavioral activation + Promotion of health behaviors

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Behavioral activation

Intervention Type BEHAVIORAL

Behavioral activation with existential themes and emphasis on values and relationships.

Promotion of health behaviors

Intervention Type BEHAVIORAL

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Internet-delivered psychological treatment, arm #6

Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Systematic exposure with mindfulness training

Intervention Type BEHAVIORAL

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Promotion of health behaviors

Intervention Type BEHAVIORAL

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Internet-delivered psychological treatment, arm #7

Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Behavioral activation

Intervention Type BEHAVIORAL

Behavioral activation with existential themes and emphasis on values and relationships.

Systematic exposure with mindfulness training

Intervention Type BEHAVIORAL

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Promotion of health behaviors

Intervention Type BEHAVIORAL

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Internet-delivered psychological treatment, arm #8

Support and information

Group Type EXPERIMENTAL

Support and information

Intervention Type BEHAVIORAL

Emotional and technical support. Information about the long-term effects of cancer.

Interventions

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Support and information

Emotional and technical support. Information about the long-term effects of cancer.

Intervention Type BEHAVIORAL

Behavioral activation

Behavioral activation with existential themes and emphasis on values and relationships.

Intervention Type BEHAVIORAL

Systematic exposure with mindfulness training

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Intervention Type BEHAVIORAL

Promotion of health behaviors

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Erland Axelsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erland Axelsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Erland Axelsson, PhD

Role: CONTACT

0706171039 ext. +46

Facility Contacts

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Erland Axelsson

Role: primary

+46 70 617 10 39

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Original study protocol

View Document

Document Type: Statistical Analysis Plan: Amendments to the study protocol

View Document

Other Identifiers

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2023-04056-01 #2

Identifier Type: -

Identifier Source: org_study_id

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