Exercise Intervention for Cancer Survivors

NCT02348710 | Completed DMC

• 1 other identifier: Pro00059469
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will test a multicomponent intervention to increase exercise Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels of exercise. Sixty early stage breast cancer survivors will be recruited from the Duke Cancer Institute. Participants will be randomized to the exercise OE intervention or an attention control group. Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer. The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of). The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• change in OE importance, as measured by questionnaire

  baseline 4- 8- and 12-weeks post intervention

• change in OE accessibility, as measured by questionnaire

  baseline 4- 8- and 12-weeks post intervention

• change in OE certainty, as measured by questionnaire

  baseline 4- 8- and 12-weeks post intervention

Secondary Outcomes (2)

• change in intentions to exercise, as measured by questionnaire

  baseline 4- 8- and 12-weeks post intervention

• change in total weekly minutes of exercise

  baseline 4- 8- and 12-weeks post intervention

Study Arms (2)

exercise outcome expectation workbook

EXPERIMENTAL

Intervention arm participants will receive: 1) the ACS exercise and diet guidelines; and 2) an exercise outcome expectation workbook. The workbook contains self-directed activities to increase OE importance, certainty, and accessibility. The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many positive exercise outcomes breast cancer survivors may experience. Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist. Accessibility will be increased by having the participant think about the association between exercise and its outcomes.

Behavioral: Exercise OE workbook

diet workbook

ACTIVE COMPARATOR

Attention control participants will receive via mail 1) the ACS exercise and diet guidelines; and 2) a diet workbook. The diet workbook contains the same activities as the exercise outcome expectation workbook but is focused on diet instead of exercise.

Behavioral: Diet workbook

Interventions

Exercise OE workbook BEHAVIORAL

The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many and diverse positive outcomes breast cancer survivors may experience. Participants will then be asked to focus on the three OEs they would most like to experience. Each section of the OE guide contains activities to target specific OE dimensions. Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist. Accessibility will be increased by having the participant think about the association between exercise and its outcomes

exercise outcome expectation workbook

Diet workbook BEHAVIORAL

The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.

diet workbook

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage 1A - 2B breast cancer diagnosis;
• months - 10 years status post surgery, radiation and chemotherapy;
• inactive (self-reported ≤ 150 min/wk moderate - strenuous-intensity exercise);
• no evidence of cancer recurrence;
• no pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program (e.g., severe orthopedic conditions, scheduled hip or knee replacement within 6 months, paralysis and/or dementia, unstable angina, history of myocardial infarction, congestive heart failure);
• English-speaking and writing;
• access and ability to use a computer for completion of online measures; and
• possession of smartphone

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University School of Nursing

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 28, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2016-08

Locations

US (1)