A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Core Exercise Promotion Intervention

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Affect-regulated exercise prescription; Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible."

Behavioral: Core Exercise Promotion Intervention; Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as "activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure	A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.	12-weeks follow-up assessment
Percentage of Sample With Valid Accelerometer Data at Baseline	The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.	Baseline assessment
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.	2-weeks follow-up assessment
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.	6-weeks follow-up assessment
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.	12-weeks follow-up assessment
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion	The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.	Baseline through 12-weeks follow-up assessments
Number of Participants Who Completed the Exit Interview	Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.	12-weeks follow-up assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up	The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.	12-weeks follow-up assessment
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire	An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.	12-weeks follow-up assessment
Study Retention at 2-weeks Follow-up	Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.	2-weeks follow-up assessment
Study Retention at 6-weeks Follow-up	Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.	6-weeks follow-up assessment
Study Retention at 12-weeks Follow-up	Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.	12-weeks follow-up assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a	An 8-item self-report measure with response options ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging from 1 (never) to 5 (always) over the past 7 days. Total scores range from 8 - 40. Higher scores reflect more fatigue.	Baseline and 12-weeks follow-up assessments
Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale	A 10-item self-report measure with response options ranging from 1 (poor/never/not at all) to 5 (excellent/completely/always) for items 1-9 and 0 (no pain) to 10 (worst pain imaginable) for the item 10. Total scores range from 9 - 45. Higher scores represent better health-related quality of life.	Baseline and 12-weeks follow-up assessments
Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a	An 8-item self-report measure with response options ranging from 1 (unable to do) to 5 (without any difficulty) and the degree to which health limits specific activities on a scale from 1 (cannot do) to 5 (not at all). Total scores range from 8 - 40. Higher scores reflect better physical function.	Baseline and 12-weeks follow-up assessments
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up	The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.	2-weeks follow-up assessment
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up	The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.	6-weeks follow-up assessment
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up	The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.	12-weeks follow-up assessment
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up	The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.	2-weeks follow-up assessment
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up	The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.	6-weeks follow-up assessment
Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire	A 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.	Baseline and 12-weeks follow-up assessments
Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)	A single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.	Baseline and 12-weeks follow-up assessments
Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale	A 5-item self-report measure of intentions to engage in physical activity. Response options range from 1 (not at all likely) to 7 (very likely). Responses are summed and then averaged; total scores range from 1-7. Higher scores represent stronger intentions to engage in physical activity.	Baseline and 12-weeks follow-up assessments
Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale	A 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise.	Baseline and 12-weeks follow-up assessments
Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)	A 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise.	Baseline and 12-weeks follow-up assessments
Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale	A 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise.	Baseline and 12-weeks follow-up assessments
Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale	A 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise.	Baseline and 12-weeks follow-up assessments

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Courtney J Stevens, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY02000934_1; K08CA259632 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No