Breast Cancer
Conditions
Keywords
Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition
Brief summary
The primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.
Interventions
BEHAVIORALMindfulness-based stress reduction
BEHAVIORALExpressive writing condition
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously * Access and regular use of the internet
Exclusion criteria
* Non Swedish speaking * Previous sever psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep quality | Baseline to 8 week follow-up change | Sleep quality as measured with the Karolinska Sleep Questionnaire (KSQ) a 13-item questionnaire assessing sleep-time and quality as well as perceived satisfaction with sleep, sleepiness and sleep disturbance. |
| Change in Perceived Stress | Baseline to 8 week follow-up change | Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention |
| Change in Psychological Well-Being | Baseline to 8 week follow-up change | Psychological Well-Being as measured with the Psychological Well-Being (PWB) scale by C Ryff; a questionnaire measuring six dimensions of psychological well-being: environmental mastery; self-acceptance; positive relations with others; purpose in life; personal growth; and autonomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological well-being | Change from baseline to 12-month follow-up | Change in psychological well-being as measured with the Psychological well-being scale. |
| Change in Perceived stress | Change from baseline to 12 months follow-up | Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R) |
| Change in Sleep quality | Change from baseline to 12-month follow-up | Change in sleep quality as measured with the Karolinska sleep questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sickness-absence for work | At 24 months follow-up | Gorup differences in sickness-absence from work as measured in national population registries |
| All cause mortality | At 24 months follow-up | Group differences in all cause mortality as measured in national registries. |
| All cause morbidity | At 24 months follow-up | Group differences in all cause morbidity as measured in national registries |
Countries
Sweden
Outcome results
None listed