NCT01849978

Brief Summary

This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

May 6, 2013

Last Update Submit

January 12, 2016

Conditions

Keywords

breast cancersurvivorexercisephysical activitystrenuous exercisemoderate exerciseenjoyable exerciseenjoy exercisebreast cancer survivor

Outcome Measures

Primary Outcomes (1)

  • change in number of minutes of moderate to strenuous physical activity

    participants will self-report minutes of physical activity at baseline, 1 month, and 3 months after receiving intervention materials.

    baseline, 1 month and 3 months

Secondary Outcomes (1)

  • changes in joy and satisfaction with physical activity

    baseline, 1 month, and 3 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Participants in this arm will receive the newsletter about their reported minutes of physical activity and the benefits of physical activity specific to breast cancer survivors, and the brochure "Changing your habits," developed by the NIH.

Behavioral: Newsletter about physical activity and breast cancer survivorsBehavioral: Changing your habits brochure

Habit Formation Arm

ACTIVE COMPARATOR

Participants in this arm will receive all of the intervention materials.

Behavioral: Newsletter about physical activity and breast cancer survivorsBehavioral: Changing your habits brochureBehavioral: Tips for making exercise enjoyable and personally-valuedBehavioral: Testimonials from breast cancer survivors

Interventions

Both groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation.

Control armHabit Formation Arm

Both groups will receive the brochure titled "Changing Your Habits: Steps to Better Health", developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA.

Control armHabit Formation Arm

Participants will get a list of potentially enjoyable activities and a space to list other activities after they consider aspects that can make events fun/interesting.13 Aspects to consider include: location (indoors vs. outdoors, the latter which may appeal to some), hobbies that can involve PA (e.g., sports, dancing), whether the activity is made more enjoyable by having it performed by oneself or with others (e.g., team activities vs. individual activities); what valued outcomes may be achieved (e.g., sense of competence, pride, better health, body image), accompanying activities that are pleasant (e.g., listening to music), etc.

Habit Formation Arm

Participants will get two to three testimonials of actual breast cancer survivors. These testimonials will include story-like details of what these survivors find enjoyable about exercising and what they have done to make exercise enjoyable.

Habit Formation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no health restrictions on performing moderate to strenuous physical activity
  • must be 18 years or older and able to give legal consent

You may not qualify if:

  • may not be participating in another research study regarding exercise
  • restrictions on performing physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • Isaac Lipkus, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 9, 2013

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations