An interventional study of Affect-based Exercise Prescription and Effort-based exercise prescription in Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Supportive care
Among 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center — 6 open to participants now, 8 under way, none of them phase 3. Breast Neoplasms · Dartmouth-Hitchcock Medical Center.
Among the 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center, this one is the 12th largest by planned enrollment of the 34 interventional ones, is one of 2 that started in 2026, is one of 19 with no phase, and was the 44th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →6 of the 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center are open now, in 1 country. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2026.
Median enrollment 30 across the 34 interventional studies, 19 across the 10 observational. Of the 35 that completed or were terminated, 10 (29%) have results posted.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
3 of the studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06522568Dartmouth-Hitchcock Medical CenterTesting a Mammography Decision Intervention in a Rural Setting | 2027-01-20 |
| NCT07706556Dartmouth-Hitchcock Medical CenterPilot SMART of a Remotely Delivered, Physical Activity Intervention for Breast Cancer Survivors | 2027-04-03 |
| NCT05716516Dartmouth-Hitchcock Medical CenterSTUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) | 2027-05 |
Among the 44 studies in Breast Neoplasms by Dartmouth-Hitchcock Medical Center, from their registry updates:
The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform \<150 minutes of MVPA at the 6-week data collection burst. Participants who performed \<150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are:
All participants will:
Some participants (those performing \<150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-≥18 years old
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Standard Exercise Promotion Program
Behavioral: Affect-based Exercise Prescription · Behavioral: Standard Exercise Promotion Program
Behavioral: Effort-based exercise prescription · Behavioral: Standard Exercise Promotion Program · Behavioral: Step-up Exercise Promotion Program
Behavioral: Affect-based Exercise Prescription · Behavioral: Standard Exercise Promotion Program · Behavioral: Step-up Exercise Promotion Program
Participants assigned to Affect-Rx will receive instructions to "select a pace of exercise that makes you feel as good as possible." The exercise intensity prescription section of their exercise plan will include the Feeling Scale as an attachment and participants will be given the instruction to "stay in the green zone" on the Feeling Scale.
Participants assigned to RPE-Rx will receive instructions to "select a pace that would make it challenging for you to carry on more than a short conversation." The exercise intensity prescription section of their exercise plan will include the Rating of Perceived Exertion (RPE) scale as an attachment and participants will be given the instruction to "stay in the green zone" on the RPE Scale.
Core intervention content will be delivered during the Visit 1, 1-month, and 2-month-check-in meetings. Definitions of exercise will be provided, participants will be asked to discuss their past experiences with exercise, guidelines for being safe during exercise will be reviewed, and strategies for overcoming potential barriers to exercise will be discussed. All participants will be given an exercise plan organized according to the FIIT Principle (Frequency, Intensity, Time, and Type). The intensity component of the exercise plan will differ by study arm, all other elements will be delivered the same for all participants. All participants will be given the goal of increasing weekly time spent exercising to ≥150 minutes, consistent with recommended guidelines. All participants will be given a smartwatch to support self-monitoring of exercise and activity levels throughout the 12-week study period.
Core intervention content will be delivered during check-in meetings scheduled during study weeks 7, 8, 9, and 10. During these visits, the interventionist will work with the participant to set weekly goals and problem-solving barriers to action. All participants will continue to receive instructions to follow their assigned exercise prescription (Affect-based Exercise Prescription or Effort-based exercise prescription). The step-up intervention calls are delivered the same regardless to which exercise prescription format the participant is assigned.
Rate of Intervention Enrollment
Number of participants who enroll in the intervention phase out of the number of participants who are eligible for the intervention phase
Time frame: Baseline 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.
Time frame: 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.
Time frame: 12-weeks follow-up assessment.
Intervention Engagement
Number of intervention sessions completed out of the number of intervention sessions scheduled
Time frame: 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.
Time frame: Time Frame: 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.
Time frame: Time Frame: 6-weeks follow-up assessment
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.
Time frame: [Time Frame: 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.
Time frame: 12-weeks follow-up assessment.
Intervention Acceptability Measured Using the Treatment Acceptability and Preferences (TAP) Measure
A 4-item self-report questionnaire used to measure intervention acceptability 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.
Time frame: 12-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.
Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
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 6 (I did vigorous activities almost daily). Total scores range from 1-6. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.
Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form
A 7-item self-report measure calculating the amount of health-related vigorous and moderate-intensity physical activity as well as sitting time performed by adult participants over a one-week period. The number of minutes per day participants report for 3 categories vigorous, moderate, and walking activities are multiplied by the average metabolic equivalent (METs) for each category (8.0 METs, 4.9 METs, and 3.3 METs, respectively). Scores for each category are summed to calculate a physical activity score for the past week quantified as total MET values. Higher METS demonstrate a higher total volume of physical activity completed in the prior week. MET values between 0-599 are considered "low active," MET values between 600-1499 are considered "moderately active," and MET values 1500 or higher are considered "High active." This measure also assesses participants' total sitting time in the past week. Total number of minutes reported for sitting time is not part of the physical activity
Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-weeks follow-up assessments.
Change Overtime in Anxiety measured using The PROMIS Anxiety Form
An 8-item self-report measure with response options ranging from 1 (never) to 5 (always). Total scores range from 8 - 40. Higher scores reflect higher levels of anxiety.
Time frame: Baseline and 12-weeks follow-up assessments.
Change Overtime in Depressive Symptoms using The PROMIS Depression Form
An 8-item self-report measure with response options ranging from 1 (never) to 5 (always). Total scores range from 8 - 40. Higher scores reflect higher levels of depressive symptoms.
Time frame: Baseline and 12-weeks follow-up assessments.
Change Overtime in Sleep Disturbance using The PROMIS Sleep Disturbance Scale
An 8-item self-report measure with response options indicating the level of sleep disturbance a participant may experience. The first question asks about sleep quality and ranges from 1 (very good) to 5 (very poor). Questions 2-8 further inquire about the specifics of the sleep experience, ranging from 1 (not at all) to 5 (very much). Total scores range from 8 - 40. Higher scores reflect a greater degree of sleep disturbance or poorer quality of sleep.
Time frame: Baseline and 12-weeks follow-up assessments.
Change Overtime in Intentions for Exercise Measured Using The Exercise Intentions Scale
A 5-item self-report measure of intentions to exercise in the next week. 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 exercise in the next week.
Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
Change Overtime in Physical Activity Enjoyment using the Physical Activity Enjoyment Scale-Short form (PACE-S)
A 4-item self-report measure with response options ranging from 1 (Strongly disagree) to 5 (Strongly agree). Total scores range from 4 - 20. Higher scores reflect higher levels of pleasure when performing physical activity.
Time frame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 9 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 9 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Dartmouth-Hitchcock Medical Center →