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Completed

NCT Number: NCT01727635

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Nursing, College of Medicine, National Taiwan University

Taipei, 10051, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

of Survivors:

  • 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.

Inclusion criteria

of Spouse partners:

  • 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.

Exclusion criteria

Exclusion criteria

of Survivors:

  • 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.

Exclusion criteria

of Survivors:

  • diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
  • those who currently use antidepressants.

Treatment and study plan

body-mind-spirit group therapy

Other

8-session therapy

Other names: group therapy

Primary outcomes

  1. Diurnal Cortisol patterns

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

Secondary outcomes

  1. The Experiences in Close Relationships-Revised questionnaire

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

  2. Beck Depression Inventory

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

  3. Quality of life

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

  4. MOS sleep scale

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

  5. Meaning in Life Questionnaire

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2012
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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