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The Long-term Effects of Body-mind-spirit Group Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01727635
First received: October 21, 2009
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
Sleep
 Other: body-mind-spirit group therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Diurnal Cortisol patterns [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Experiences in Close Relationships-Revised questionnaire [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: Yes ]
  • MOS sleep scale [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: Yes ]
  • Meaning in Life Questionnaire [ Time Frame: pre, post, 3months, 6months and 1year after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: counseling
body-mind-spirit group therapy
 Other: body-mind-spirit group therapy
8-session therapy
Other Name: group therapy

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727635

Locations
Taiwan
Department of Nursing, College of Medicine, National Taiwan University
Taipei, Taiwan, 10051
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fei Hsiao, PhD National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01727635     History of Changes
Other Study ID Numbers: 200909010R
Study First Received: October 21, 2009
Last Updated: November 12, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Breast cancer, survivors, partners, group therapy

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013