Internet-based Support for Adjustment to Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Internet-based cognitive behavioral therapy, Non-directive support.
- Who it may be relevant to
- Registry conditions: Psychological Distress, Depression - Major Depressive Disorder, Insomnia, Anxiety. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer
Overview
The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.
Detailed description
Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.
This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.
Interventions
- Behavioral Internet-based cognitive behavioral therapy
An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase. - Behavioral Non-directive support
Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.
Primary outcome measures
- Kessler-10 (K10) [Time frame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
Secondary outcome measures (6)
- Fear of Cancer Recurrence Inventory, short form (FCRI) [Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
- Generalized Anxiety Disorder-7 item scale (GAD-7) [Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
- Insomnia Severity Index (ISI) [Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
- Brunnsviken Brief Quality of Life Scale (BBQ) [Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
- The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) [Time frame: At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
- The Illness Cognition Questionnaire (ICQ) [Time frame: At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.]
Eligibility criteria
Inclusion criteria
- Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
- A sum score above 19 on the primary outcome measure (Kessler-10).
- An age of 18 or older.
- Ability to speak, read, and write Swedish.
- Access to a computer/laptop/tablet/smartphone and internet access.
- Sufficient computer profiency to be able to use the treatment platform.
Exclusion criteria
- Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
- Recently finished (within the past six months) medical treatment for prostate cancer.
- Severe psychiatric or somatic conditions that impedes participation in the study.
- Ongoing substance use problems.
- Acute suicidality.
- Other ongoing psychological treatment.
- Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Department of Behavioral Sciences and Learning — Linköping
Identifiers
NCT: NCT06766526 · ISAC