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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903249
• Other study ID #: STUDY02000934_1
• Secondary ID: K08CA259632
• Status: Completed
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 13, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Clinic	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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