Breast Cancer Female
Conditions
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.
Interventions
BEHAVIORALMoving On After 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.
Sponsors
Lynn Sage Breast Cancer Research Foundation
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Biostatistician generated the randomization list. The research assistant called the PI for group assignment after baseline measures were taken.
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC Information-25 (EORTC-QLQ-INFO25) | Change from baseline to 1 month after baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale | Change from baseline to 1 month after baseline | 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. |
Outcome results
None listed