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Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors

Primary Purpose

Anxiety Disorder, Breast Cancer, Cancer Survivor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
study of socioeconomic and demographic variables
CAM exercise therapy
psychosocial assessment and care
quality-of-life assessment
stress management therapy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder focused on measuring anxiety disorder, depression, cognitive/functional effects, psychosocial effects of cancer and its treatment, cancer survivor, breast cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Breast cancer survivor

    • At least 12 months since completion of treatment (chemotherapy, biotherapy [e.g., trastuzumab], or radiotherapy)
  • No evidence of metastatic disease

PATIENT CHARACTERISTICS:

  • English speaking
  • Not under acute psychological distress
  • Not using an assistive device (cane, walker, or wheelchair)
  • Able to participate in the Mindful Movement Program by a medical release from the patient's physician
  • Pregnancy allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent selective estrogen-receptor modulator permitted
  • No other concurrent treatment

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Effects of the Mindful Movement Program on psychological well-being, distress, fear of recurrence, physical well-being, upper-body symptom bother, social well-being, body image, and spiritual well-being at baseline and weeks 12 and 18
Effects of this program on attention and attitude
Differences of attention and attitude between the experimental group and the control group
Perceptions of the program as described by the experimental group

Secondary Outcome Measures

Full Information

First Posted
May 15, 2009
Last Updated
June 3, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00903474
Brief Title
Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors
Official Title
Mindful Movement Program for Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention, and attitude) and physical movement. A mindful movement program may be effective in improving well-being in older women who are breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well a mindful movement program works in improving quality of life in older female breast cancer survivors.
Detailed Description
OBJECTIVES: To test the effects of the 12-week Mindful Movement Program on quality of life in older female breast cancer survivors. To test the effects of this program on mindfulness outcomes in these participants. To compare mindfulness qualities in the experimental group with the control group. To determine the qualitative benefits of this program as described by these participants. OUTLINE: Participants are randomized to 1 of 2 intervention arms. Arm I (Mindful Movement Program [MMP]): Participants undergo a 2-hour MMP session once weekly for 12 weeks. Participants are encouraged to practice intentional-mindful movement at home 5 minutes daily during weeks 1-4, 10 minutes daily during weeks 5-8, and 15 minutes daily during weeks 9-12. Mindful movement is a self-directed activity incorporating mindfulness concepts and physical movement. Mindfulness consists of the three core elements: intention (reasons for participating in a mindfulness intervention), attention (observing experiences in the present moment), and attitude (nonjudgmental openness and acceptance of experiences). Each MMP session includes verbal sharing with a partner and the group and movement individually and with a partner, while focusing on the elements of mindfulness. Music is incorporated into some portion of each session. Arm II (control): Participants undergo no intervention. All participants complete questionnaires for sociodemographic and individual characteristics, quality of life (including psychological, social, spiritual, and physical well-being, anxiety and depression, fear of recurrence, body image, and upper body symptoms), movement, and mindfulness (including attention, self-compassion, and intention) at baseline and weeks 12 and 18. PROJECTED ACCRUAL: A total of 75 participants (45 in the experimental group and 30 in the control group) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Breast Cancer, Cancer Survivor, Cognitive/Functional Effects, Depression, Psychosocial Effects of Cancer and Its Treatment
Keywords
anxiety disorder, depression, cognitive/functional effects, psychosocial effects of cancer and its treatment, cancer survivor, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
CAM exercise therapy
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
stress management therapy
Primary Outcome Measure Information:
Title
Effects of the Mindful Movement Program on psychological well-being, distress, fear of recurrence, physical well-being, upper-body symptom bother, social well-being, body image, and spiritual well-being at baseline and weeks 12 and 18
Time Frame
6 months after study entry
Title
Effects of this program on attention and attitude
Time Frame
6 months after study entry
Title
Differences of attention and attitude between the experimental group and the control group
Time Frame
6 months after study entry
Title
Perceptions of the program as described by the experimental group
Time Frame
6 months after entry

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Breast cancer survivor At least 12 months since completion of treatment (chemotherapy, biotherapy [e.g., trastuzumab], or radiotherapy) No evidence of metastatic disease PATIENT CHARACTERISTICS: English speaking Not under acute psychological distress Not using an assistive device (cane, walker, or wheelchair) Able to participate in the Mindful Movement Program by a medical release from the patient's physician Pregnancy allowed PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent selective estrogen-receptor modulator permitted No other concurrent treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Crane-Okada, PhD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

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Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors

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