Depression, Sleep
Conditions
Keywords
Breast cancer, survivors, partners, group therapy
Brief summary
Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.
Detailed description
Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.
Interventions
OTHERbody-mind-spirit group therapy
8-session therapy
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria of Survivors: 1. breast cancer patients who complete active treatments, 2. those who are willing to participate in the research, 3. those who currently do not receive any individual or group psychotherapy, AND 4. aged between 18 and 65. Inclusion criteria of Spouse partners: 1. partners of breast cancer patient who complete active treatments, 2. those who are willing to participate in the research, 3. those who currently do not receive any individual or group psychotherapy, AND 4. aged between 18 and 65.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diurnal Cortisol patterns | pre, post, 3months, 6months and 1year after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| The Experiences in Close Relationships-Revised questionnaire | pre, post, 3months, 6months and 1year after end of treatment |
| Beck Depression Inventory | pre, post, 3months, 6months and 1year after end of treatment |
| Quality of life | pre, post, 3months, 6months and 1year after end of treatment |
| MOS sleep scale | pre, post, 3months, 6months and 1year after end of treatment |
| Meaning in Life Questionnaire | pre, post, 3months, 6months and 1year after end of treatment |
Countries
Taiwan
Outcome results
None listed