Breast CancerNCT04903249

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

A study testing Core Exercise Promotion Intervention in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: Core Exercise Promotion Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2021to 13 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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

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

Conditions: Breast Cancer
Being tested: Core Exercise Promotion Intervention
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core Exercise Promotion InterventionBehavioural
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 groups in NCT04903249
Study group	Role	What they receive
Affect-regulated exercise prescription	Experimental	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." Receives: Behavioral: Core Exercise Promotion Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 12-weeks follow-up assessment

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-weeks follow-up assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202113 Jun 2022

First posted26 May 2021
Study start10 Aug 2021
Primary completion10 Jun 2022
Study completion13 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04903249
Sponsor's protocol ID: STUDY02000934_1
Other IDs: K08CA259632
Status last verified: Jul 2023
First submitted: 23 May 2021
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stevens CJ, Bobak CA, Morrissette KJ, Thompson RC, Lyons KD, Wallace GM, Emerson AJ, Conroy DE, Williams DM, Chamberlin MD, Bruce ML. Exercise That Feels as Good as Possible: Acceptability of an Affect-Based Exercise Prescription Among Stage 0-III Breast Cancer Survivors. Psychooncology. 2025 Aug;34(8):e70225. doi: 10.1002/pon.70225.
PubMed 40736469

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04903249
Acronym / sponsor ID: STUDY02000934_1
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 10 Aug 2021 (actual)
Primary completion: 10 Jun 2022 (actual)
Study completion: 13 Jun 2022 (actual)
First posted: 26 May 2021 (actual)
Results: Posted 27 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Affect-regulated exercise prescription	Experimental	Behavioral: Core Exercise Promotion InterventionParticipants 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."

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core Exercise Promotion InterventionParticipants 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.	Behavioural	Affect-regulated exercise prescription

Primary outcome

Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
Time frame: 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.
Percentage of Sample With Valid Accelerometer Data at Baseline
Time frame: Baseline assessment
The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up
Time frame: 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%.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up
Time frame: 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%.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up
Time frame: 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%.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion
Time frame: Baseline through 12-weeks follow-up assessments
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.
Number of Participants Who Completed the Exit Interview
Time frame: 12-weeks follow-up assessment
Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.

5 secondary outcomes

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
Time frame: 12-weeks follow-up assessment
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
Time frame: 12-weeks follow-up assessment
Study Retention at 2-weeks Follow-up
Time frame: 2-weeks follow-up assessment
Study Retention at 6-weeks Follow-up
Time frame: 6-weeks follow-up assessment
Study Retention at 12-weeks Follow-up
Time frame: 12-weeks follow-up assessment

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Affect-regulated Exercise Prescription	37	30

Primary outcome: Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure

Time frame: 12-weeks follow-up assessment. Mean (Standard Deviation). Unit: score on a scale

Measure	Affect-regulated Exercise Prescription n = 30
Value	3.31 (.53)

Primary outcome: Percentage of Sample With Valid Accelerometer Data at Baseline

Time frame: Baseline assessment. Count of participants. Unit: Participants

Measure	Affect-regulated Exercise Prescription n = 35
Value	33

Population analysed: 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).

Primary outcome: Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up

Time frame: 2-weeks follow-up assessment. Count of participants. Unit: Participants

Measure	Affect-regulated Exercise Prescription n = 30
Value	28

Primary outcome: Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up

Time frame: 6-weeks follow-up assessment. Count of participants. Unit: Participants

Measure	Affect-regulated Exercise Prescription n = 30
Value	28

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 weeks. After participants initially enroll in the study there is often a period of a week or more before they can be scheduled for their intervention orientation meeting. The intervention portion of the study last 12 weeks. Often it takes a week or more before participants can be scheduled for their exit interview after the end of the 12 week intervention. Thus, participants are assessed for a period of approximately 15 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Affect-regulated Exercise Prescription	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40736469Stevens CJ, Bobak CA, Morrissette KJ, Thompson RC, Lyons KD, Wallace GM, Emerson AJ, Conroy DE, Williams DM, Chamberlin MD, Bruce ML. Exercise That Feels as Good as Possible: Acceptability of an Affect-Based Exercise Prescription Among Stage 0-III Breast Cancer Survivors. Psychooncology. 2025 Aug;34(8):e70225. doi: 10.1002/pon.70225.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Courtney J Stevens, PhD principal investigator

Dartmouth-Hitchcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Core Exercise Promotion Intervention in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure (time frame: 12-weeks follow-up assessment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04903249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.