NCT03100981

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

Completed NA Last updated 8 January 2019

What this trial tests

NA trial testing Internet-delivered Mindfulness-Based Cognitive Therapy in Anxiety Depression in 150 participants. Completed in 27 June 2018.

Timeline

24 February 2016

Primary endpoint
27 November 2017

27 June 2018

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	24 February 2016
Primary completion	27 November 2017
Estimated completion	27 June 2018
Sites	1 location across Denmark

Drugs / interventions tested

• Internet-delivered Mindfulness-Based Cognitive Therapy
• Waitlist control

Conditions studied

• Anxiety Depression — all drugs for Anxiety Depression →
• Breast Cancer Female — all drugs for Breast Cancer Female →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Anxiety Depression or Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: A randomized controlled trial.
   Nissen ER, O'Connor M, Kaldo V, Højris I, et al · · 2020 · cited 86× · PMID 31600414 · DOI 10.1002/pon.5237
2. Internet-delivered Mindfulness-Based Cognitive Therapy for anxiety and depression in cancer survivors: Predictors of treatment response.
   Nissen ER, Zachariae R, O'Connor M, Kaldo V, et al · · 2021 · cited 19× · PMID 33552930 · DOI 10.1016/j.invent.2021.100365
3. Patient involvement in the development of a psychosocial cancer rehabilitation intervention: evaluation of a shared working group with patients and researchers.
   Nissen ER, Bregnballe V, Mehlsen MY, Muldbjerg AKØ, et al · · 2018 · cited 12× · PMID 30123530 · DOI 10.1186/s40900-018-0106-2