Clinical trial NCT04903249: A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation
Official title: Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
* \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
* Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
* Willing to wear the ActiGraph monitor during assessment periods
* Access to internet to complete REDCap survey assessments

Exclusion Criteria:

* Non-English speaking/not able to read English
* Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
* Currently pregnant
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
* Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
* Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
* Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Primary outcomes:
measure: Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
timeFrame: 12-weeks follow-up assessment
measure: Percentage of Sample With Valid Accelerometer Data at Baseline
timeFrame: Baseline assessment
measure: Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up
timeFrame: 2-weeks follow-up assessment
measure: Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up
timeFrame: 6-weeks follow-up assessment
measure: Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up
timeFrame: 12-weeks follow-up assessment
measure: Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion
timeFrame: Baseline through 12-weeks follow-up assessments
measure: Number of Participants Who Completed the Exit Interview
timeFrame: 12-weeks follow-up assessment
Secondary outcomes:
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
timeFrame: 12-weeks follow-up assessment
measure: Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
timeFrame: 12-weeks follow-up assessment
measure: Study Retention at 2-weeks Follow-up
timeFrame: 2-weeks follow-up assessment
measure: Study Retention at 6-weeks Follow-up
timeFrame: 6-weeks follow-up assessment
measure: Study Retention at 12-weeks Follow-up
timeFrame: 12-weeks follow-up assessment
Other outcomes:
measure: Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up
timeFrame: 2-weeks follow-up assessment
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up
timeFrame: 6-weeks follow-up assessment
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up
timeFrame: 12-weeks follow-up assessment
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
timeFrame: 2-weeks follow-up assessment
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
timeFrame: 6-weeks follow-up assessment
measure: Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale
timeFrame: Baseline and 12-weeks follow-up assessments
measure: Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale
timeFrame: Baseline and 12-weeks follow-up assessments
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Clinic
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Courtney J Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: