Trial Outcomes & Findings for A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation (NCT NCT04903249)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

12-weeks follow-up assessment

Results posted on

2023-07-27

Participant Flow

1 participant signed consent but did not engage in any reach activities and no data was collected for this individual.

Participant milestones

Participant milestones
Measure	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." 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.
Overall Study STARTED	37
Overall Study Received Intervention	30
Overall Study Week 2 Follow-up	30
Overall Study Week 6 Follow-up	30
Overall Study Week 12 Follow-up	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Affect-regulated Exercise Prescription n=37 Participants 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." 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	57.81 years STANDARD_DEVIATION 10.30 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-weeks follow-up assessment

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure	3.31 score on a scale Standard Deviation .53

PRIMARY outcome

Timeframe: Baseline assessment

Population: Two of the N = 37 participants enrolled at baseline withdrew before starting accelerometer data collection. Thus, accelerometer data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure).

The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=35 Participants 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." 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.
Percentage of Sample With Valid Accelerometer Data at Baseline	33 Participants

PRIMARY outcome

Timeframe: 2-weeks follow-up assessment

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%.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up	28 Participants

PRIMARY outcome

Timeframe: 6-weeks follow-up assessment

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%.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up	28 Participants

PRIMARY outcome

Timeframe: 12-weeks follow-up assessment

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%.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up	28 Participants

PRIMARY outcome

Timeframe: Baseline through 12-weeks follow-up assessments

Population: Two of the N = 37 participants enrolled at baseline withdrew before starting EMA data collection. Thus, EMA data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure).

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=35 Participants 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." 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.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion	84.83 percentage of EMA prompts completed

PRIMARY outcome

Timeframe: 12-weeks follow-up assessment

Population: Participants who completed the exit interview

Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Number of Participants Who Completed the Exit Interview	30 participants

SECONDARY outcome

Timeframe: 12-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 12-weeks follow-up. N = 28 participants had valid wear time at 12-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=28 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up	32.97 minutes of daily MVPA Standard Deviation 40.17

SECONDARY outcome

Timeframe: 12-weeks follow-up assessment

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire	3.33 score on a scale Standard Deviation .63

SECONDARY outcome

Timeframe: 2-weeks follow-up assessment

Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Study Retention at 2-weeks Follow-up	30 participants

SECONDARY outcome

Timeframe: 6-weeks follow-up assessment

Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Study Retention at 6-weeks Follow-up	30 participants

SECONDARY outcome

Timeframe: 12-weeks follow-up assessment

Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Study Retention at 12-weeks Follow-up	30 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a	-1.50 units on a scale Standard Deviation 5.40

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale	.60 score on a scale Standard Deviation 3.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a	.40 score on a scale Standard Deviation 4.24

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-weeks follow-up assessment

Population: Data was missing from N = 1 participant, total sample size at 2 weeks follow up was N = 30.

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=29 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up	16.36 minutes per day Standard Deviation 15.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-weeks follow-up assessment

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up	11.61 minutes per day Standard Deviation 14.70

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-weeks follow-up assessment

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up	17.13 minutes per day Standard Deviation 16.77

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 2-weeks follow-up. N = 28 participants had valid wear time at 2-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=28 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up	30.48 minutes of daily MVPA Standard Deviation 17.20

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 6-weeks follow-up. N = 28 participants had valid wear time at 6-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=28 Participants 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." 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.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up	29.11 minutes of daily MVPA Standard Deviation 15.84

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire	1.93 score on a scale Standard Deviation 4.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)	.80 score on a scale Standard Deviation .89

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale	.27 score on a scale Standard Deviation 1.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale	-2.82 score on a scale Standard Deviation 21.58

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)	-.14 score on a scale Standard Deviation .96

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale	-.36 score on a scale Standard Deviation 1.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12-weeks follow-up assessments

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.

Outcome measures

Outcome measures
Measure	Affect-regulated Exercise Prescription n=30 Participants 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." 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.
Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale	-.49 score on a scale Standard Deviation 1.33

Adverse Events

Affect-regulated Exercise Prescription

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtney J. Stevens, PhD, Principal Investigator

Dartmouth-Hitchcock Medical Center

Phone: 603-650-9643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place