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

Dartmouth Health

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Core Exercise Promotion Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04903249

K08CA259632 (U.S. NIH Grant/Contract)

STUDY02000934_1

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Affect-regulated exercise prescription

Experimental group

Description:

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."

Treatment:

Behavioral: Core Exercise Promotion Intervention