Moving On Study - Pilot Test

NCT04681989 | Completed

• 1 other identifier: STU00206619
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to conduct a pilot test of "Moving On After Breast Cancer (MOVE-ABC)" - a physical therapy based educational intervention designed to reduce and manage breast cancer-related physical and functional impairments. This pilot test will allow the investigator to determine whether MOVE-ABC is feasible and holds promise for efficacy for delivery after breast cancer treatment has ended just as the breast cancer survivor enters the surveillance for recurrence phase of cancer survivorship. The study team will be recruiting breast cancer survivors who have just finished intent-to-cure treatment and are just about to execute their cancer survivorship plans.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• EORTC Information-25 (EORTC-QLQ-INFO25)

  EORTC-QLQ-INFO25 is a 25- item survey with 4 multi-item sub-scales on satisfaction with information on cancer, medical tests, treatment, other services. It has high internal consistency (α\>0.90) with sub-scales ranging between .70 -.82. Test-retest reliability is good (intraclass correlation coefficients \>0.70). Convergent validity is supported by significant correlation with other information satisfaction surveys (r\>0.40).

  Change from baseline to 1 month after baseline

Secondary Outcomes (1)

• Self-efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale

  Change from baseline to 1 month after baseline

Study Arms (2)

MOVE-ABC intervention arm

EXPERIMENTAL

MOVE-ABC interventional group participants receive usual care plus the MOVE-ABC education instruction and materials. After the participant completes the baseline assessment (T0) and been given the study survey by a research staff member she will receive the following: 1. instructions on the education materials by a research staff member 2. a range of motion wand 3. a small ball 4. MOVE-ABC education booklet and video The intervention group will complete 4 weekly follow-ups with a research staff member over the phone. The follow-ups will be completed in between the T0 (baseline) assessment, and the T1 (1 month after baseline) assessment. The follow-up phone calls are expected to take 20 - 30 minutes each time. During these follow-ups research staff will review material, and answer any questions the participant may have. All documentation of phone calls and questions asked by participants during these reviews will be captured in REDCap.

Behavioral: Moving On After Breast Cancer

Control/Usual Care arm

NO INTERVENTION

Control group participants will be measured at baseline and at 1 month follow-up. They receive usual care. Usual care does not include specialized, physical therapy-based education on recovery from breast cancer.

Interventions

Moving On After Breast Cancer BEHAVIORAL

After the MOVE-ABC interventional group participant completes their baseline assessment (T0) and been given the study survey by a research staff member she will receive the following: 1. Instructions on how to use the physical therapy-based education materials by a research staff member 2. a range of motion wand 3. a small ball 4. MOVE-ABC education booklet and video The intervention group will complete 4 weekly follow-ups with a research staff member over the phone. The follow-ups will be completed in between the T0 (baseline) assessment, and the T1 (1 month after baseline) assessment.

Also known as: MOVE-ABC

MOVE-ABC intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed and treated BC (stages 0-4)
• female
• English speaking
• years old or older

You may not qualify if:

• previous history of cancer (except non-melanoma skin)
• history of shoulder impairment (e.g. shoulder osteoarthritis, rotator cuff tear, adhesive capsulitis)
• pregnancy
• central nervous system damage (e.g.: spinal cord injury, brain injury, multiple sclerosis, etc.)
• dementia
• systemic medical conditions and/or metal implants (e.g. fibromyalgia, rheumatoid arthritis, diabetes, joint replacement, cardiac pacemaker, port-a-cath etc.)
• upper extremity(ies) amputation
• actively receiving physical therapy for any reason prior to enrollment

Sponsors & Collaborators

• Northwestern University: lead
• Lynn Sage Breast Cancer Research Foundation: collaborator

Related Publications (4)

• Martins da Silva RC, Rezende LF. Assessment of impact of late postoperative physical functional disabilities on quality of life in breast cancer survivors. Tumori. 2014 Jan-Feb;100(1):87-90. doi: 10.1700/1430.15821.

  PMID: 24675497 BACKGROUND

• Binkley JM, Harris SR, Levangie PK, Pearl M, Guglielmino J, Kraus V, Rowden D. Patient perspectives on breast cancer treatment side effects and the prospective surveillance model for physical rehabilitation for women with breast cancer. Cancer. 2012 Apr 15;118(8 Suppl):2207-16. doi: 10.1002/cncr.27469.

  PMID: 22488695 BACKGROUND

• Pinto M, Gimigliano F, Tatangelo F, Megna M, Izzo F, Gimigliano R, Iolascon G. Upper limb function and quality of life in breast cancer related lymphedema: a cross-sectional study. Eur J Phys Rehabil Med. 2013 Oct;49(5):665-73. Epub 2013 May 23.

  PMID: 23698473 BACKGROUND

• Hack TF, Kwan WB, Thomas-Maclean RL, Towers A, Miedema B, Tilley A, Chateau D. Predictors of arm morbidity following breast cancer surgery. Psychooncology. 2010 Nov;19(11):1205-12. doi: 10.1002/pon.1685.

  PMID: 20099254 BACKGROUND

Study Officials

• Ann M Flores, PT, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Biostatistician generated the randomization list. The research assistant called the PI for group assignment after baseline measures were taken.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomized to either the intervention or control group after baseline (within 1 month of completing active, intent-to-cure breast cancer treatment) measurement by research assistants. Follow-up outcome measures at 1 month after baseline.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share