Moving On Study - Pilot Test (MOST-PT)

Northwestern University

Status: Completed

Conditions: Breast Cancer Female

Treatments: Behavioral: Moving On After Breast Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04681989

STU00206619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

MOVE-ABC intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Moving On After Breast Cancer

Control/Usual Care arm

No Intervention group

Description:

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.