Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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.

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.

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.

Moving On After Breast Cancer

Ann M Flores, PT, PhD

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.

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.

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.

Biostatistician generated the randomization list. The research assistant called the PI for group assignment after baseline measures were taken.

Moving On Study - Pilot Test

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).

The Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale inquires about self-confidence in prevention of disease side effects (e.g., fatigue, pain, emotional distress, other symptoms) from interfering with daily activity, managing health care needs, and aspects of disease without medication. This scale has been used in cancer and chronic musculoskeletal disease studies.

Lynn Sage Breast Cancer Research Foundation

Northwestern University

Associate Professor

Breast Diseases

Skin Diseases

Participants are randomized to the intervention arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Participants are given the patient education materials (booklet, therapeutic exercise DVD, small ball, range of motion wand). The research assistant orients the participant to the education materials and summarizes each section of the booklet. The research assistant also teaches the participant how to do the therapeutic exercises in the booklet. All participants in the intervention also receive usual care.

Participants are randomized to the usual care arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Usual care consists of pre-operative testing, pre-operative nursing education on care of the surgical incision and pain management followed by breast cancer surgery.

Patient education intervention that is evidence-based, physical therapy, patient \& family centered through the use of face to face instruction, a booklet, and therapeutic exercise DVD. The education materials are designed to deliver information on short term, long term, and late physical and functional effects of breast cancer treatment and given to breast cancer survivors before beginning cancer treatment. The education materials are designed to be used before, during, and after breast cancer treatment.

Ann M Flores, PhD

The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.

This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.

Randomized controlled trial, longitudinal and prospective

Moving On - An RCT to Test Physical Therapy Education

"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates

Active shoulder range of motion is measured with a standard goniometer in degrees. Change from baseline to 3 months for shoulder flexion, extension, abduction, and internal and external ranges are measured.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Moving On Study - Pilot Test	NCT04681989	Breast Cancer F...	Moving On After...	21 Years -	Northwestern University
Moving On Study - Pilot Test	NCT04681989	Breast Cancer F...	Moving On After...	21 Years -	Northwestern University
Moving On - An RCT to Test Physical Therapy Education	NCT04731805	Breast Cancer	Moving On After...	21 Years -	Northeastern University

Spots Global Cancer Trial Database for moving on after breast cancer