Clinical trial NCT06258993: A Randomized Two-Arm Proof of Concept Study Testing a Novel Approach to Exercise Promotion Based on Affect-regulation
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 (Study 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-14
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the effect of an affect-based exercise prescription on moderate-vigorous physical activity participation among survivors of breast cancer who completed primary treatment within the last 5 years. The main questions it aims to answer are:

1. Do at least 50% of participants assigned to the affect-based exercise prescription engage in ≥90 minutes of moderate-vigorous physical activity by the end of 12-weeks follow-up?
2. What level of satisfaction do breast cancer survivors who receive the affect-based exercise prescription report relative to breast cancer survivors who receive an effort-based exercise prescription.
3. What proportion of participants assigned to the affect-based exercise prescription stay enrolled in the study relative to the number of participants who stay enrolled in the effort-based exercise prescription.

All participants will:

* Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription.
* Participate in two meetings with a member of the study team meant to help them get started increasing weekly exercise. These meetings are the same for all participants.
* Be asked to wear an activity monitor and respond to brief surveys for 10 straight days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Within 5 years of completing primary cancer treatment (surgery, chemotherapy, and radiation) for Stage 0-III breast cancer
* \<60 mins/week moderate-vigorous physical activity (MVPA) with no major changes for the past 6- months
* Own an Android or iPhone smartphone (or tablet) and willing to use it to complete app-based surveys during assessment periods
* Willing to wear the ActiGraph monitor during assessment periods
* Access to internet to complete REDCap survey assessments

Exclusion Criteria:

* Non-English speaking/not able to read English
* Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
* Currently pregnant
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
* Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the 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.

Primary outcomes:
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up
timeFrame: 2-weeks follow-up assessment.
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up
timeFrame: 6-weeks follow-up assessment.
measure: Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up
timeFrame: 12-weeks follow-up assessment.
Secondary outcomes:
measure: Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire
timeFrame: 12-weeks follow-up assessment.
measure: Study Retention at 2-weeks Follow-up
timeFrame: 2-weeks follow-up assessment.
measure: Study Retention at 6-weeks Follow-up
timeFrame: 6-weeks follow-up assessment.
measure: Study Retention at 12-weeks Follow-up
timeFrame: 12-weeks follow-up assessment.
measure: Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure
timeFrame: 12-weeks follow-up assessment.
measure: Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire
timeFrame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
measure: Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)
timeFrame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
measure: Change in Physical Activity using The International Physical Activity Questionnaire (IPAQ)-Short Form
timeFrame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
Other outcomes:
measure: Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Anxiety measured using The PROMIS Anxiety Form
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Depressive Symptoms using The PROMIS Depression Form
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Sleep Disturbance using The PROMIS Sleep Disturbance Scale
timeFrame: Baseline and 12-weeks follow-up assessments.
measure: Change Overtime in Intentions for Exercise Measured Using The Exercise Intentions Scale
timeFrame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
measure: Change Overtime in Physical Activity Enjoyment using the Physical Activity Enjoyment Scale-Short form (PACE-S)
timeFrame: Baseline, 6-weeks follow-up, and 12-weeks follow-up.
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Clinic
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitcock Health
name: Courtney J Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: