Trial Outcomes & Findings for Increasing Physical Activity Among Breast Cancer Survivors With Depression (NCT NCT02781051)

NCT ID: NCT02781051

Last Updated: 2019-02-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-02-22

Participant Flow

Participant milestones

Measure	Physical Activity Intervention 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.).
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Physical Activity Among Breast Cancer Survivors With Depression

Baseline characteristics by cohort

Measure	Physical Activity Intervention n=16 Participants 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.).
Age, Continuous	55.19 years STANDARD_DEVIATION 8.70 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Quick Inventory of Depressive Symptomatology - Self-Rated	13.63 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants
Moderate-to-Vigorous Physical Activity	52.4 Minutes per week STANDARD_DEVIATION 19.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 12 participants provided valid baseline and follow-up data.

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

Outcome measures

Measure

Physical Activity Intervention n=12 Participants 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.).

Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer

56.2 minutes per week Standard Deviation 23.4

SECONDARY outcome

Timeframe: 6 months

Population: 14 participants provided follow-up data

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

Outcome measures

Measure

Physical Activity Intervention n=14 Participants 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.).

Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)

9.7 units on a scale Standard Deviation 4.5

Adverse Events

Physical Activity Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chad Rethorst, Associate Professor

UT Southwestern Medical Center

Phone: 2146480153

Email: chad.rethorst@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place