Clinical trial NCT03100981: Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer
Official title: Internet-delivered Mindfulness-Based Cognitive Therapy for Symptoms of Depression, Anxiety, and Stress Among Women Treated for Breast Cancer and Men Treated for Prostate Cancer - Effects and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Breast Cancer Female
Prostate Cancer
Keywords: Mindfulness-Based Cognitive Therapy
Internet-delivered
Breast cancer
Prostate cancer
Survivors
Depression
Anxiety
Stress
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Karolinska Institutet
name: Region Stockholm
First posted: 2017-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After baseline assessment, participants will be randomly assigned to either the intervention or the control group. Both groups will receive online questionnaires at 5 weeks (midway), 10 weeks (post treatment) and 36 weeks (6 months follow-up) after baseline assessment.

The intervention group receives a therapist phone call prior to enrollment in the internet-delivered treatment and then participates in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy. The internet-delivered treatment also comprises weekly distress measures, including suicide risk screening, and assessment of working alliance at week 2, 4, and 7 of the course.
Primary purpose: TREATMENT

Brief summary: AIM: The aim of the present study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) can reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer compared to a treatment as usual control group. Furthermore, the effect of I-MBCT on symptoms of stress, insomnia, quality of life, and self-compassion and the potential mediating effect of working alliance and mindfulness will be explored. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.

BACKGROUND: Symptoms of depression, anxiety, and stress are prevalent late-effects among cancer patients and -survivors. Mindfulness-based interventions aim at improving affect tolerance and emotion regulation, which could be of particular relevance for cancer patients and survivors, and MBCT has been shown efficacious in treating symptoms of depression, anxiety, and stress among cancer patients and survivors. However, the availability of face-to-face delivered MBCT is limited and hence using the internet to deliver MBCT may be a cost-effective way of increasing the accessibility of the intervention to vulnerable patients with limited resources.

METHODS: A total of 155 participants will be recruited from Department of Oncology and Department of Urology at Aarhus University Hospital and randomized to two groups: I-MBCT and a treatment-as-usual wait-list control group. Assessments will be conducted at pre-, midway and post intervention and at a 6- months follow-up.

Detailed description: BACKGROUND

Symptoms of depression, anxiety, and stress is common among both cancer patients and cancer survivors and can lead to prolonged hospitalization, reduced quality of life, and deteriorate prognosis. In Mindfulness-Based Cognitive Therapy (MBCT) participants practice attention towards the present moment and acceptance of feelings and physical discomfort. This is in particular relevant for cancer patients and -survivors who often experience psychological symptoms connected to negative thoughts about the past and worries about the future.

MBCT is an 8-week group intervention and has shown to be effective in treating psychological distress in cancer survivors. Many cancer survivors experience challenges in following a group intervention because of health related reduced mobility and work- and family schedule conflicts, and hence it is relevant to investigate an internet-delivered alternative to MBCT.

I-MBCT is a manualized treatment for breast- and prostate cancer survivors, based on the manual for Mindfulness-Based Cognitive Therapy for depression. I-MBCT consist of 8 weeks of mindfulness practice combined with reading theory and supported by weekly text messages and answers from a therapist.

AIMS AND HYPOTHESES

In a randomized controlled trial the efficacy of 8-weeks I-MBCT for breast- and prostate cancer survivors will be investigated.

1. The primary aim of the study is to investigate if Internet-delivered Mindfulness-Based Cognitive Therapy (I-MBCT) will reduce symptoms of depression and anxiety among women treated for breast cancer and men treated for prostate cancer and that the effect is remained at 6 months after the treatment.
2. The secondary aim is to explore the effect of I-MBCT on symptoms of stress, insomnia, and quality of life.
3. Furthermore, the study aims to explore the potential mediating effect of working alliance, self-compassion, and mindfulness.
4. Finally, the cost-effectiveness of the I-MBCT intervention will be explored.

PARTICIPANTS AND PROCEDURES

A total of 155 breast- and prostate cancer survivors are consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinics at Department of Oncology and Department of Urology will screen patients for psychological distress at follow-up check-ups. If the patients indicates a moderate to high level of psychological distress, further information about the project will be given and patients can sign up for study enrollment.

Participants will after initial screening receive a phone call from a project staff to clarify if inclusion criteria are met. After informed consent all participants will fill out the online baseline questionnaire and then be randomized to either I-MBCT or a wait-list control group receiving treatment as usual in a ratio of 7:3 by means of a computer-generated randomization list.

Participants fill out online questionnaires at baseline, midway (after 5 weeks), post treatment (after 10 weeks) and at follow-up after 6 months.

The intervention group receive the 8-weeks of therapist-assisted I-MBCT which contains assessment of the Therapeutic Alliance at 2, 4, and 7 weeks after treatment onset.

The statistical evaluation of the effect I-MBCT compared to the waitlist control will be performed with Multilevel Linear Models and post-hoc tests. The possible mediating effects will be evaluated using Preacher \& Hayes bootstrapping method. All analyses will be performed with a two-sided significance level of .05.

REGISTRATION DETAILS

The study record reported in ClinicalTrials.gov is completely consistent with the protocol approved by the Central Region Denmark Committee on Health Research Ethics before enrollment start. The study was registered in ClinicalTrials.gov after enrollment had started but before any data analysis was initiated.

Eligibility criteria: Inclusion Criteria:

* Man treated for prostate cancer or woman treated for breast cancer
* Active cancer treatment must have been completed (radiation therapy, operation and chemotherapy) within the past 5 years. Ongoing endocrine therapy is all right.
* A minimum score of 3 on anxiety and/or depression items from Symptom Check-List-8, subscale in Common Mental Disorder Questionnaire (SCL-8, CMDQ).
* Internet access on a daily basis
* Must have a cell phone

Exclusion Criteria:

* Cancer recurrence or ongoing cancer treatment.
* Problems with reading and/or understanding Danish
* Insufficient IT skills
* Severe mental illness causing problems with following the internet-delivered treatment, e.g. dementia, known psychotic disorder or developmental disorder.

Primary outcomes:
measure: Symptoms of Depression
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
measure: Symptoms of Anxiety
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
Secondary outcomes:
measure: Symptoms of Stress
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
measure: Cost-Effectiveness
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
Other outcomes:
measure: Insomnia
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
measure: Self-compassion
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
measure: Quality of Life
timeFrame: Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment
Locations:
city: Aarhus
country: Denmark
facility: Department of Psychology, Aarhus University
state: Central Region Denmark
Study officials:
affiliation: University of Aarhus
name: Eva R Nissen, MSc
role: STUDY_CHAIR
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