Physical Activity and Neuropsychological Outcomes in a Cancer Population

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT02332876
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

Many cancer survivors experience treatment-related impairments in mental abilities such as memory, attention, and concentration (known as cognition). Research indicates that physical activity can improve cognition in healthy adults; however, little is known about whether physical activity can improve cognition among cancer survivors. This study will test whether a physical activity intervention results in improvements in cognition among breast cancer survivors, which may lead to interventions to improve cognition.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Dysfunction; Breast Cancer Survivors	Behavioral: Exercise; Behavioral: Control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Intervention This arm will receive a 12-week individually tailored phone and email-based exercise program.	Behavioral: Exercise
Active Comparator: Wellness Waitlist Control This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.	Behavioral: Control

Outcome Measures

Primary Outcome Measures

1. National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test [Baseline to 12 weeks]

   Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• breast cancer survivors; diagnosed at stage 1, 2, or 3 less than 5 years ago -

• not scheduled for or currently undergoing chemotherapy; sedentary, defined as engaging in less than 60 minutes of moderate to vigorous physical activity each week

• accessible geographically and by telephone

• have access to the internet

• endorse experience difficulties with thinking abilities

• in addition, participants on adjuvant therapy (e.g., tamoxifen or aromatase inhibitors) must be able and willing to remain on that treatment for the 3-month intervention period to prevent confounding of biomarker concentrations by treatment.

Exclusion Criteria:

• history of coronary heart disease, diabetes, stroke, orthopedic conditions that limit mobility, or any other serious medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention

• other primary or recurrent invasive cancer within the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)

• unable to commit to a 3-month intervention schedule; any condition that, in the investigators' judgment, would contraindicate increased physical activity or otherwise interfere with participation in the trial

• unable to provide a blood sample at the baseline measurement visit

• unable to speak and read English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moores UCSD Cancer Center	La Jolla	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT02332876
• Other Study ID Numbers: 1K07CA181323-01A1
• First Posted: Jan 7, 2015
• Last Update Posted: Jul 11, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Exercise Intervention	Wellness Waitlist Control
Arm/Group Description	This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program. Exercise	This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program. Control
Period Title: Overall Study
STARTED	43	44
COMPLETED	42	43
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Exercise Intervention	Wellness Waitlist Control	Total
Arm/Group Description	This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program. Exercise	This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program. Control	Total of all reporting groups
Overall Participants	43	44	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.2 (11.37)	56.2 (9.30)	57.2 (10.36)
Sex: Female, Male (Count of Participants)
Female	43 100%	44 100%	87 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 18.6%	7 15.9%	15 17.2%
Not Hispanic or Latino	35 81.4%	37 84.1%	72 82.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 7%	3 6.8%	6 6.9%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.3%	1 1.1%
Black or African American	1 2.3%	1 2.3%	2 2.3%
White	36 83.7%	35 79.5%	71 81.6%
More than one race	3 7%	4 9.1%	7 8%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test
Description	Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Intervention	Wellness Waitlist Control
Arm/Group Description	This arm received a Fitbit along with a 12-week individually tailored phone and email-based exercise program. Exercise	This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program. Control
Measure Participants	43	44
Mean (Standard Deviation) [units on a scale]	7 (10.2)	3 (8.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise Intervention, Wellness Waitlist Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Arm/Group Title	Exercise Intervention		Wellness Waitlist Control
Arm/Group Description	This arm will receive a 12-week individually tailored phone and email-based exercise program. Exercise		This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program. Control
All Cause Mortality
	Exercise Intervention		Wellness Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exercise Intervention		Wellness Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Exercise Intervention		Wellness Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/44 (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.