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

Dartmouth-Hitchcock Medical Center37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Core Exercise Promotion InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer * \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months * Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods * Willing to wear the ActiGraph monitor during assessment periods * Access to internet to complete REDCap survey assessments Exclusion Criteria: * Non-English speaking/not able to read English * Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+) * Currently pregnant * History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium) * Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8) * Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener) * Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Locations (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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.

Time frame: 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%.

Time frame: 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%.

Time frame: 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%.

Time frame: 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%.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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: 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

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.

Time frame: 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.

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