Increasing Physical Activity Among Breast Cancer Survivors With Depression

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02781051
• Collaborator: American Cancer Society, Inc. (Other)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Condition or Disease	Intervention/Treatment	Phase
Depression; Physical Activity; Breast Cancer	Behavioral: Print-based education; Device: Fitbit; Behavioral: Active Living counseling; Other: Facility Access	N/A

Detailed Description

The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Increasing Physical Activity Among Breast Cancer Survivors With Depression
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Physical Activity Intervention Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.

Behavioral: Print-based education; All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.; Device: Fitbit; Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.; Behavioral: Active Living counseling; The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.; Other: Facility Access; Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).

Outcome Measures

Primary Outcome Measures

1. Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer [6 months]

   Assess changes in physical activity at 6 months following physical activity intervention.

Secondary Outcome Measures

1. Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) [6 months]

   Assess changes in depressive symptoms at 6 months following physical activity intervention. Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Positive depression screen (PHQ-9) or current antidepressant treatment

• Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ

• Physically able to engage in physical activity

• Written and verbal fluency in English

Exclusion Criteria:

• Medical condition contraindicating physical activity participation

• Recurrence of breast cancer

• Ductal carcinoma in situ (DCIS) diagnosis

• Cognitively unable to give informed consent

• Non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• American Cancer Society, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 29, 2015

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02781051
• Other Study ID Numbers: STU 122015-072
• First Posted: May 24, 2016
• Last Update Posted: Feb 22, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	Participants receive a multi-component physical activity intervention for 12 weeks. Print-based education: All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers. Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily. Active Living Every Day: 12 weekly group educational sessions, facilitated by project interventionists. Topics included: identifying and overcoming barriers, setting goals, and time management. Facility Access: Subjects had access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Period Title: Overall Study
STARTED	16
COMPLETED	14
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers. Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily. Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management. Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.19 (8.70)
Sex: Female, Male (Count of Participants)
Female	16 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 12.5%
Not Hispanic or Latino	14 87.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	15 93.8%
More than one race	0 0%
Unknown or Not Reported	1 6.3%
Quick Inventory of Depressive Symptomatology - Self-Rated (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.63 (4.5)
Moderate-to-Vigorous Physical Activity (Minutes per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes per week]	52.4 (19.5)

Outcome Measures

1. Primary Outcome

Title	Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer
Description	Assess changes in physical activity at 6 months following physical activity intervention.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

12 participants provided valid baseline and follow-up data.

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers. Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily. Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management. Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Measure Participants	12
Mean (Standard Deviation) [minutes per week]	56.2 (23.4)

2. Secondary Outcome

Title	Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)
Description	Assess changes in depressive symptoms at 6 months following physical activity intervention. Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

14 participants provided follow-up data

Arm/Group Title	Physical Activity Intervention
Arm/Group Description	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers. Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily. Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management. Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
Measure Participants	14
Mean (Standard Deviation) [units on a scale]	9.7 (4.5)

Adverse Events

Time Frame	6 months
Arm/Group Title	Physical Activity Intervention
Arm/Group Description	Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up. Print-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers. Fitbit: Subjects were provided a Fitbit and instructed to wear the device daily. Active Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management. Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
All Cause Mortality
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Physical Activity Intervention
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.