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Completed

NCT Number: NCT04681989

Moving On Study - Pilot Test

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moving On After Breast Cancer

Behavioral

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:

  • Instructions on how to use the physical therapy-based education materials by a research staff member
  • a range of motion wand
  • a small ball
  • 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.

Other names: MOVE-ABC

Primary outcomes

  1. EORTC Information-25 (EORTC-QLQ-INFO25)

    Time frame: 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 outcomes

  1. Self-efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Lynn Sage Breast Cancer Research Foundation

Registry information

Acronym: MOST-PT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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