An interventional study of Moving On After Breast Cancer in Breast Cancer Female, sponsored by Northwestern University. Completed. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
Also known as: MOVE-ABC
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).
Time frame: Change from baseline to 1 month after baseline
Self-efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale
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.
Time frame: Change from baseline to 1 month after baseline
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Northwestern University