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

NCT ID: NCT04903249

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-06-13

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Affect-regulated exercise prescription

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."

Group Type: EXPERIMENTAL

Core Exercise Promotion Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Core Exercise Promotion Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Courtney J. Stevens

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Courtney J Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40736469 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K08CA259632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY02000934_1

Identifier Type: -

Identifier Source: org_study_id