Breast Cancer
Conditions
Keywords
Couple Functioning, Stress Reduction
Brief summary
This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.
Detailed description
Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.
Interventions
BEHAVIORALCouples MBSR
Both members of the couple will be asked to participate in the weekly video sessions and activities.
BEHAVIORALIndividual MBSR
Only the young breast cancer survivor will participate in the weekly video sessions and activities.
Sponsors
University of Missouri, St. Louis
University of Missouri, Kansas City
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years to 45 years old when diagnosed with breast cancer 2. Diagnosed with stage 0, I, II, III breast cancer 3. within 1 to 6 years after diagnosis of breast cancer 4. Married or unmarried and living together. 5. Living anywhere in the United States 6. Both members of the couple must understand, read, and speak English 7. Both members of the couple must have regular access to email and willingness to use the Internet.
Exclusion criteria
1\. Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Partner Responsiveness | Baseline to 8 weeks | This scale will be measured each week for the 8 weeks of the intervention |
| Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in couple functioning measured by the Sexual Interest and Satisfaction Scale | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in couple functioning measured by the Interpersonal Mindfulness Scale | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in salivary cortisol biomarker to assess stress levels | Baseline to 8 weeks | Saliva will be analyzed for cortisol and summary scores will be calculated for each condition (no individual scores will be reported). |
| Change in anxiety scores measured by PROMIS -- Anxiety | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Changes in trait mindfulness measured by Mindful Attention and Awareness Scale | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in depression scores measured by the PROMIS -- Depression | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in fatigue scores measured by PROMIS -- Fatigue | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Change in stress scores measured by the Perceived Stress Scale | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
| Changes in physical functioning measured by the PROMIS - Physical Function | Baseline to 6 months | The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported). |
Countries
United States
Outcome results
None listed