Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
Brief Summary: A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.

Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.

The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.

The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.


Options:
A: Inclusion Criteria:

* 21 years old or older
* Diagnosed with Stage 0, I, II, or III breast cancer
* Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of treatment to 18 months post-treatment)
* Ability to read and speak English at the 8th grade level to respond to the survey questions

Exclusion Criteria:

* Advanced stage (IV) breast cancer
* History of mastectomy
* Current psychiatric diagnosis
* Recurrent treatment for prior breast cancer
B: Inclusion Criteria:

* A timeframe of \>3 months from surgery, radiation- and chemotherapy and a minimum score of \>3 on a pain scale from 0-10 corresponding to moderate pain

Exclusion Criteria:

* Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand Danish, and chronic pain otherwise associated with the musculoskeletal system
C: Inclusion Criteria:

* diagnosed with stage I or II breast cancer in preceding 36 months
* 21-64 years of age
* access to and ability to use a computer and the internet to communicate with others
* fluent in spoken English
* meet the screening criteria for psychological distress (score \>7 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scales

Exclusion Criteria:

* currently taking medication for depression
D: Inclusion Criteria

* Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H\&N cancer
* Sufficient language ability to understand and complete the questionnaires without assistance
* No obvious cognitive impairments, as judged by the study coordinator upon inclusion
* Age 18 years or above
* Provision of written informed consent
* No participation in another trial or study possibly interfering with the present study

Exclusion Criteria:

* Patients being diagnosed with basal cell carcinoma
* Patients who have been included in Phase I-III of the module development
* Patients who are in the terminal phase of cancer
* Patients who are unable to participate in the interviews do to obvious cognitive impairment, psychological disturbance or language problems

Answer: B