Online Mindfulness for Women Treated for Breast Cancer and Men Treated for Prostate Cancer

NCT03100981 | Completed DMC

• 4 other identifiers: Krop & SindR87-A54327-12.0736R113-A7015-14-S34
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Depression; Breast Cancer Female; Prostate Cancer

Keywords

Mindfulness-Based Cognitive Therapy; Internet-delivered; Breast cancer; Prostate cancer; Survivors; Depression; Anxiety; Stress

Outcome Measures

Primary Outcomes (2)

• Symptoms of Depression

  Change in symptoms of depression assessed by Beck Depression Inventory II (BDI-II)

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

• Symptoms of Anxiety

  Change in symptoms of anxiety assessed by State-Trait Anxiety Inventory Form Y (STAI-S)

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

Secondary Outcomes (2)

• Symptoms of Stress

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

• Cost-Effectiveness

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

Other Outcomes (3)

• Insomnia

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

• Self-compassion

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

• Quality of Life

  Change from baseline until post treatment (10 weeks after baseline) and 6 months post treatment

Study Arms (2)

Internet-delivered MBCT

EXPERIMENTAL

The intervention group will immediately receive 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy.

Behavioral: Internet-delivered Mindfulness-Based Cognitive Therapy

Waitlist control

OTHER

The control group will be on a waiting list to participate in Internet-delivered MBCT after the 6-months follow-up time has passed.

Behavioral: Waitlist control

Interventions

Internet-delivered Mindfulness-Based Cognitive Therapy BEHAVIORAL

Internet-delivered Mindfulness-Based Cognitive Therapy is a trainer-assisted course based on the manual for Mindfulness-Based Cognitive Therapy for depression. The course consists of 8 modules, one per week, for 8 weeks and one additional week for flexibility for the participants. In total 9 weeks with weekly written contact to the personal instructor. Each module has an overall theme with written theory, approximately 45 minutes of daily mindfulness practice and other daily assignments with the purpose of strengthening awareness in the everyday life.

Also known as: Mindfulness-Based Cognitive Therapy, I-MBCT, MBCT

Internet-delivered MBCT

Waitlist control BEHAVIORAL

Participants in the control arm of the study will receive treatment as usual, which means that they are not offered interventions targeting psycho-social distress but also not prevented from participating in or seeking other psycho-social treatment during the course of the study. After the 6-months follow-up time has passed participants will get the opportunity to participate in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy, if the intervention is found efficient.

Also known as: Treatment as usual

Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Department of Psychology, Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms; Depression; Anxiety Disorders

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eva R Nissen, MSc

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors performing introduction calls are masked in the sense that participants will not be randomized until after the introduction call. All questionnaires are completed as online surveys and are hence masked for group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 4, 2017
• Study Start: February 24, 2016
• Primary Completion: November 27, 2017
• Study Completion: June 27, 2018
• Last Updated: January 8, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)