Clinical trial NCT01727635: The Long-term Effects of Body-mind-spirit Group Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Sleep
Keywords: Breast cancer, survivors, partners, group therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diurnal Cortisol patterns
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
Secondary outcomes:
measure: The Experiences in Close Relationships-Revised questionnaire
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
measure: Beck Depression Inventory
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
measure: Quality of life
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
measure: MOS sleep scale
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
measure: Meaning in Life Questionnaire
timeFrame: pre, post, 3months, 6months and 1year after end of treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Nursing, College of Medicine, National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Fei Hsiao, PhD
role: PRINCIPAL_INVESTIGATOR
References: