NCT01727635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 depression

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1 year until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

2.1 years

First QC Date

October 21, 2009

Last Update Submit

November 12, 2012

Conditions

DepressionSleep

Keywords

Breast cancer, survivors, partners, group therapy

Outcome Measures

Primary Outcomes (1)

  • Diurnal Cortisol patterns

    pre, post, 3months, 6months and 1year after end of treatment

Secondary Outcomes (5)

  • 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

Study Arms (1)

counseling

EXPERIMENTAL

body-mind-spirit group therapy

Other: body-mind-spirit group therapy

Interventions

body-mind-spirit group therapyOTHER

8-session therapy

Also known as: group therapy
counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • breast cancer patients who complete active treatments,
  • those who are willing to participate in the research,
  • those who currently do not receive any individual or group psychotherapy, AND
  • aged between 18 and 65.
  • partners of breast cancer patient who complete active treatments,
  • those who are willing to participate in the research,
  • those who currently do not receive any individual or group psychotherapy, AND
  • aged between 18 and 65.

You may not qualify if:

  • diagnosed as both breast cancer and other types of cancers,
  • those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
  • those who currently use antidepressants.
  • diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
  • those who currently use antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing, College of Medicine, National Taiwan University

Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

DepressionBreast Neoplasms

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fei Hsiao, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

November 16, 2012

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

TW(1)