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

NCT04903249 | Completed Results DMC

• 2 other identifiers: STUDY02000934_1K08CA259632
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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%.

  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%.

  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%.

  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%.

  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.

  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.

  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

  12-weeks follow-up assessment

• Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire

  12-weeks follow-up assessment

• Study Retention at 2-weeks Follow-up

  2-weeks follow-up assessment

• Study Retention at 6-weeks Follow-up

  6-weeks follow-up assessment

• Study Retention at 12-weeks Follow-up

  12-weeks follow-up assessment

Other Outcomes (15)

• Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a

  Baseline and 12-weeks follow-up assessments

• Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale

  Baseline and 12-weeks follow-up assessments

• Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a

  Baseline and 12-weeks follow-up assessments

Study Arms (1)

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."

Behavioral: Core Exercise Promotion Intervention

Interventions

Core Exercise Promotion Intervention 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.

Affect-regulated exercise prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dartmouth-Hitchcock Clinic

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• 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.

  PMID: 40736469 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Courtney J. Stevens, PhD, Principal Investigator
• Organization: Dartmouth-Hitchcock Medical Center

courtney.j.stevens@dartmouth.edu

603-650-9643

Study Officials

• Courtney J Stevens, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 26, 2021
• Study Start: August 10, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 13, 2022
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)