Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer? A study of factors associated with enrollment among Danish breast cancer patients.
Study Goal
The researchers aimed to identify demographic and clinical differences between participants and decliners in a mindfulness-based stress reduction (MBSR) trial for breast cancer patients.
Results Summary
Participants were younger, had a less recent diagnosis, and higher education than decliners. Significant differences were found in psychological measures (distress, anxiety, depression, well-being, symptom burden) but not in breast cancer variables, co-morbidity, or lifestyle factors.
Population
Women with breast cancer eligible for a randomized controlled trial.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
mindfulness-based stress reduction MBSR | decrease | age | participants (women eligible for a randomized controlled trial) | - | were found to be younger | #1 |
mindfulness-based stress reduction MBSR | decrease | time since diagnosis | participants (women eligible for a randomized controlled trial) | - | have a less recent diagnosis at invitation | #2 |
mindfulness-based stress reduction MBSR | increase | use of psychologist sessions | participants (women eligible for a randomized controlled trial) | - | a statistically significant difference was also found | #3 |
mindfulness-based stress reduction MBSR | increase | level of education | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #4 |
mindfulness-based stress reduction MBSR | increase | distress | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #5 |
mindfulness-based stress reduction MBSR | increase | anxiety | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #6 |
mindfulness-based stress reduction MBSR | increase | depression | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #7 |
mindfulness-based stress reduction MBSR | increase | well being | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #8 |
mindfulness-based stress reduction MBSR | increase | symptom burden | participants (women eligible for a randomized controlled trial) | - | showed statistically significant differences | #9 |
mindfulness-based stress reduction MBSR | no change | marital status | participants (women eligible for a randomized controlled trial) | - | No differences were observed | #10 |
mindfulness-based stress reduction MBSR | no change | children living at home | participants (women eligible for a randomized controlled trial) | - | No differences were observed | #11 |
mindfulness-based stress reduction MBSR | no change | affiliation to the work market | participants (women eligible for a randomized controlled trial) | - | No differences were observed | #12 |
mindfulness-based stress reduction MBSR | no change | psychiatric caseness | participants (women eligible for a randomized controlled trial) | - | No differences were observed | #13 |
mindfulness-based stress reduction MBSR | no change | any lifestyle measure | participants (women eligible for a randomized controlled trial) | - | No differences were observed | #14 |
BACKGROUND: Discussion regarding the necessity to identify patients with both the need and motivation for psychosocial intervention is ongoing. Evidence for an effect of mindfulness-based interventions among cancer patients is based on few studies with no systematic enrollment. METHODS: We used Danish population-based registries and clinical databases to determine differences in demographics, breast cancer and co-morbidity among 1208 women eligible for a randomized controlled trial (www.clinicaltrials.gov identifier: NCT00990977) of mindfulness-based stress reduction MBSR. RESULTS: Participants (N = 336) were found to be younger (p < 0.001) and have a less recent diagnosis at invitation than decliners (N = 872; p < 0.001). After adjustment for age and time since diagnosis at invitation, a statistically significant difference was also found between the two groups in use of psychologist sessions (p < 0.05), whereas neither breast cancer variables nor co-morbidity was significantly different. Self-reported data obtained by use of validated psychometric scales from 169 decliners and 336 women who agreed to enroll in the trial showed statistically significant differences in level of education, distress, anxiety, depression, well being and symptom burden. No differences were observed with regard to marital status, children living at home, affiliation to the work market, psychiatric caseness or any lifestyle measure. CONCLUSION: Our findings indicate that participants are younger, have a less recent diagnosis and have a higher level of education than those who refuse. This should be taken into account in designing and evaluating trials of psychosocial interventions and in planning mindfulness-based interventions.