Breast Cancer and Resistance Exercise Program

NCT04562233 | Terminated

• 2 other identifiers: Pro2020002182132012
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to test the feasibility and acceptability of a supervised, online-delivered, individualized, physical activity program in a sample of post-active treatment breast cancer survivors. The proposed intervention will use a 2-arm randomized controlled trial study design to compare a 12-week resistance-based physical activity program to an attention control (i.e., printed individualized physical activity program) group on feasibility, acceptability and changes in strength as measured by 10 repetition maximum (10RM). Both groups will wear accelerometers. The main hypothesis is that participants randomized to the intervention arm will rate the online-delivered physical activity program as feasible and acceptable compared to attention control participants. The overall rationale is that delivering a physical activity intervention online may increase uptake of the intervention, which may lead to maintained physical activity behavior and associated health benefits. The primary outcomes are feasibility as measured by participant retention and acceptability as measured by adherence to physical activity program (recorded by physical activity log). Secondary outcomes include changes in strength as measured by 10RM, objectively measured physical activity levels as measured by the accelerometer, satisfaction, physical functioning and health-related quality of life. Additionally, a select number of participants will be invited for an interview to talk about their experiences in the program, motivation and barriers to exercise. Interview description: Participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and audio recorded using the "record meeting" function. Prior to the interview, participants will consent to being audio recorded. The recording will be stored on Box (a HIPAA compliant cloud drive). A transcript of the audio will be generated using the "audio transcript" function on Rutgers Zoom and transcribed by a third party to ensure accuracy.

Conditions

Breast Cancer; Resistance Training

Keywords

online; breast cancer; physical activity; breast neoplasm; resistance exercise; survivor

Outcome Measures

Primary Outcomes (3)

• Feasibility (participant retention)

  Participant retention at assessment timepoints (attendance and completing assessments)

  14 weeks including pre-intervention and post-intervention questionnaire completion

• Acceptability (program adherence)

  Adherence to physical activity program/intervention (attendance and exercise logs)

  12 weeks to complete the intervention

• Internet Evaluation and Utility Questionnaire

  Satisfaction will be measured as participants' experience and perceptions of an internet intervention. Scale values: Not at all, slightly, somewhat, mostly \& very. Higher scores are associated with a greater level of satisfaction.

  After the 12 week intervention and captured in follow-up questionnaire for intervention arm participants

Secondary Outcomes (7)

• 10 Repetition Maximum Test

  During the baseline assessment, week 12 assessment and week 24 follow up assessment

• Godin Leisure Time Exercise Questionnaire

  During the baseline assessment, week 12 assessment and week 24 follow up assessment

• Accelerometer (ActiGraph)

  Prior to intervention start and following the Week 12 and week 24 assessments

• Senior Fitness Test

  During the baseline assessment, week 12 assessment and week 24 follow up assessment

• Exercise Self-Efficacy Questionnaire

  During the baseline assessment, week 12 assessment and week 24 follow up assessment

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer. Once a week, the exercise trainer and participant will each log on to Zoom from their locations to begin the supervised exercise session. The exercise trainer will record all sessions. Sessions will be 30 to 45 minutes long and be structured as follows: review of previous session and an opportunity to ask questions; 5-minute warm-up; 20- to 25-minute workout; 5- to10-minute cool down and reminder of next session and/or data collection time period. Supervised sessions will be scheduled once a week over the 12-week intervention. Participants will be expected to complete their resistance-based physical activity program for an additional 1-2 days a week as per the intervention schedule to meet as physical activity guidelines. The exercise trainer will track participant attendance. During the session, participants must have another person in the same location in case of an emergency.

Behavioral: Online-delivered physical activity intervention.

Control Arm

OTHER

The attention control arm will include a printed, individualized resistance-based physical activity program. Participants randomized to the control arm will be given a printed or digital individualized, resistance-based physical activity program and told to aim to for three exercise sessions per week. Control participants will follow the same measurement schedule as intervention participants.

Behavioral: Printed, individualized resistance-based physical activity program.

Interventions

Online-delivered physical activity intervention. BEHAVIORAL

Participants randomized to the intervention arm will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer.

Intervention arm

Printed, individualized resistance-based physical activity program. BEHAVIORAL

Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years and older
• self-identify as Black or African American or Afro-Latina/e
• a confirmed diagnosed of breast cancer \< 10 years prior to study start
• does not have a concurrent cancer diagnosis
• have completed active treatment \> 6 months prior to study commencement (hormonal therapy is acceptable)
• who are inactive, defined as engaging in \< 30 minutes of moderate-to-vigorous physical activity per day for 3 days per week
• are able to exercise safely as per physical activity safety screening questionnaire, Get Active Questionnaire
• read and understand English
• h) have regular access to an internet-connected device with a video camera.

You may not qualify if:

• respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire
• metastatic disease
• planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., breast reconstruction surgery)
• does not have someone to supervise them while they exercised remotely.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (8)

• Ritterband LM, Bailey ET, Thorndike FP, Lord HR, Farrell-Carnahan L, Baum LD. Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia. Psychooncology. 2012 Jul;21(7):695-705. doi: 10.1002/pon.1969. Epub 2011 Apr 29.

  PMID: 21538678 BACKGROUND

• Amireault S, Godin G, Lacombe J, Sabiston CM. The use of the Godin-Shephard Leisure-Time Physical Activity Questionnaire in oncology research: a systematic review. BMC Med Res Methodol. 2015 Aug 12;15:60. doi: 10.1186/s12874-015-0045-7.

  PMID: 26264621 BACKGROUND

• Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.

  PMID: 9060536 BACKGROUND

• Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.

  PMID: 10882320 BACKGROUND

• McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757.

  PMID: 8433355 BACKGROUND

• Get Active Questionnaire. Ottawa, Canada: Canadian Society of Exercise Physiology, 2016.

  BACKGROUND

• Hilgart M, Ritterband L, Baxter K, Alfano A, Ratliff C, Kinzie M, Cohn W, Whaley D, Lord H, Garber S. Development and perceived utility and impact of a skin care Internet intervention. Internet Interventions. 2014;1(3):149-57. doi: 10.1016/j.invent.2014.07.003; PMCID: PMC Journal - In Process.

  BACKGROUND

• Fong AJ, Llanos AAM, Hudson SV, Schmitz K, Lu SE, Phillips SM, Manne SL. Online-delivered resistance exercise intervention among racially diverse breast cancer survivors: Feasibility, acceptability, and exploratory outcomes of B-REP. Support Care Cancer. 2024 Aug 1;32(8):565. doi: 10.1007/s00520-024-08769-9.

  PMID: 39090218 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Fong, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrative

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: December 1, 2020
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available to investigators after one month of data collection and up to 3 years after completion of research activities per Rutgers (ORRA) guidelines.
• Access Criteria: Prior approved investigators authorized to review the data will have access to individual participant data.

Locations

US (1)