Clinical trial NCT04681989: Moving On Study - Pilot Test
Official title: Moving On Study - Pilot Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Lynn Sage Breast Cancer Research Foundation
First posted: 2020-12-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The investigators hypothesize that MOVE-ABC is a critical missing link in the standard of care to reduce impairments and improve confidence to manage impairments. The research team is positioned to pilot test MOVE-ABC to address (a) self- management of breast cancer-related impairments via patient-centered booklet and video each impairment identified by our breast cancer survivors; (b) instruction on self-management of impairments with the "Moving On" booklet and video (Attachment 4.1); and (c) weekly follow-up (up to 1 month after the end of breast cancer treatment) to answer questions, concerns and review "Moving On". This research also supports a small but growing number of studies that point to self-management interventions informed by rehabilitation as a means to fill this gap in usual care. The investigator has already piloted the "Moving On" intervention among surgical candidates for breast cancer surgery. The question remains whether "Moving On" is acceptable and feasible for breast cancer survivors who have already completed their breast cancer treatment and are just beginning to execute their breast cancer survivorship plans.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: EORTC Information-25 (EORTC-QLQ-INFO25)
timeFrame: Change from baseline to 1 month after baseline
Secondary outcomes:
measure: Self-efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale
timeFrame: Change from baseline to 1 month after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Ann M Flores, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.