The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners
18 Years
65 Years
Both
Depression, Sleep
Trial Information
The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners
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.
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.
Exclusion Criteria:
Exclusion criteria of Survivors:
1. diagnosed as both breast cancer and other types of cancers,
2. those with adrenal function disorders (for example, Cushing syndrome, Addison's
disease, adrenal tumor, pituitary tumor), OR
3. those who currently use antidepressants.
Exclusion criteria of Survivors:
1. diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's
disease, adrenal tumor, pituitary tumor), OR
2. those who currently use antidepressants.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Diurnal Cortisol patterns
Outcome Time Frame:
pre, post, 3months, 6months and 1year after end of treatment
Safety Issue:
Yes
Principal Investigator
Fei Hsiao, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Taiwan University
Authority:
Taiwan: Department of Health
Study ID:
200909010R
NCT ID:
NCT01727635
Start Date:
October 2009
Completion Date:
November 2011
Related Keywords:
- Depression
- Sleep
- Breast cancer, survivors, partners, group therapy
- Breast Neoplasms
- Depression
- Depressive Disorder
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