Clinical trial NCT04777786: Early Rehabilitation for Breast Cancer - A Randomized Control Trial
Official title: Implementation of a Prospective Surveillance Rehabilitation Model for Women With Breast Cancer - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neoplasms, Breast
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Prisma Health-Midlands
First posted: 2021-03-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial design
Primary purpose: TREATMENT

Brief summary: Upper extremity strength, range of motion, activity limitations, fatigue and pain are well-documented concerns for women receiving treatment for breast cancer. Research has shown that cancer-related treatment side effects are amenable to rehabilitation interventions when identified early during treatment for breast cancer. Despite this, early rehabilitation has been reported in only 1-2% of individuals diagnosed with cancer. The Prospective Surveillance Model (PSM), a comprehensive model of survivorship care supported by the American Cancer Society and the National Cancer Institute, recommends a baseline assessment (near the time of diagnosis) and ongoing surveillance and intervention of impairments that minimize the impact of cancer treatments. A significant gap in knowledge currently exists with regards to the effectiveness of employing the PSM.

The purpose of this study is to examine the impact of implementing the PSM on impairments and functional limitations in women diagnosed with breast cancer during the first six months of treatment. A randomized controlled trial will be applied to examine a total of 28 women diagnosed with stage I-III breast cancer who will receive a mastectomy at Prisma Health in Columbia, S.C. Women will be randomized to one of two groups: PSM or usual care.

Detailed description: The overall objective of this study is to examine the impact of employing early rehabilitation by implementing a randomized controlled trial at Prisma Health Midlands on women diagnosed with stage I-III breast cancer who will receive a mastectomy.

The following outcomes will be collected at 3-time points (baseline, 3 months and 6 months post-surgery)

* Objective measures: Upper extremity active range of motion, upper extremity, strength, physical function, and arm volume
* Patient reported (questionnaire) measures: Upper extremity function, functional mobility, balance, health-related quality f life, pain, fatigue, falls and distress.

The patient reported measures will also be collected electronically 24 hours after each of the 3 assessments (baseline, 3 months and 6 months post-surgery)

Each of the 3 study visits will last \~60 minutes.

If you are randomized into the intervention group, you will receive \~10 treatment visits with a licensed physical therapist. Scheduling will be at your convenience and based on what the physical therapist recommends. Those in the intervention group will receive individualized physical therapy treatments based on impairments identified. Treatment may include but is not limited to the following: passive, assisted and active ROM, manual therapy, soft tissue massage, myofascial release, therapeutic activities and exercise and patient education. Treatment duration and frequency will be specific to each patient, providing personalized care. Physical therapy intervention will occur 1-2x/week for 3-6 weeks beginning \~4 weeks after surgery (x̄=10 visits). Each visit will last \~60 minutes in duration.

The usual care groups will be instructed to continue with their typical daily activities.

All study participants will receive a handout containing education and home exercise instruction which is considered routine care.

Participants will receive a $25 gift card gift card for each completed in person assessment (baseline, 3 and 6 months post surgery) for a total of $75.

Eligibility criteria: Inclusion Criteria:

* Eligible participants include adult female patients, ≥18 years of age, with a primary first-time diagnosis of breast cancer, and referred on or after January 1, 2021 for mastectomy surgery.

Exclusion Criteria:

* Women will be excluded if they will have bilateral surgery, breast-conserving surgery, recurrence of breast cancer, stage IV, or neoadjuvant treatment prior to surgery.

Primary outcomes:
measure: Change in Active range of motion
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
Secondary outcomes:
measure: Upper extremity strength
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Upper Extremity Function
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Upper Extremity Function
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Balance
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Health-Related Quality of Life
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: NCCN Distress Thermometer
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: NCCN Distress Problem list
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: Pain interference
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: Pain intensity
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: Fatigue
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery. 24 hours after baseline assessment, 24 hours after 3-and 6-month post-surgery assessments
measure: Falls
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Arm volume
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: 2-minute step test
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: 30 second sit to stand
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Timed arm curl
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
measure: Timed up and go
timeFrame: Pre-surgery (baseline), 3- and 6-months post-surgery.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References:
citation: Harrington S, Padua D, Battaglini C, Michener LA, Giuliani C, Myers J, Groff D. Comparison of shoulder flexibility, strength, and function between breast cancer survivors and healthy participants. J Cancer Surviv. 2011 Jun;5(2):167-74. doi: 10.1007/s11764-010-0168-0. Epub 2011 Jan 12.
citation: Becker, A.M., Vanlandingham, S., Grogan, M.M., McGowan, M.H., Harrington, S.E. (2019) Impact of Early Rehabilitation in Women Actively Receiving Treatment for Breast Cancer. Rehabilitation Oncology. 38(1): E20, January 2020.
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citation: Stout NL, Binkley JM, Schmitz KH, Andrews K, Hayes SC, Campbell KL, McNeely ML, Soballe PW, Berger AM, Cheville AL, Fabian C, Gerber LH, Harris SR, Johansson K, Pusic AL, Prosnitz RG, Smith RA. A prospective surveillance model for rehabilitation for women with breast cancer. Cancer. 2012 Apr 15;118(8 Suppl):2191-200. doi: 10.1002/cncr.27476.
citation: Stout NL, Silver JK, Raj VS, Rowland J, Gerber L, Cheville A, Ness KK, Radomski M, Nitkin R, Stubblefield MD, Morris GS, Acevedo A, Brandon Z, Braveman B, Cunningham S, Gilchrist L, Jones L, Padgett L, Wolf T, Winters-Stone K, Campbell G, Hendricks J, Perkin K, Chan L. Toward a National Initiative in Cancer Rehabilitation: Recommendations From a Subject Matter Expert Group. Arch Phys Med Rehabil. 2016 Nov;97(11):2006-2015. doi: 10.1016/j.apmr.2016.05.002. Epub 2016 May 27.
citation: Schmitz KH, Stout NL, Andrews K, Binkley JM, Smith RA. Prospective evaluation of physical rehabilitation needs in breast cancer survivors: a call to action. Cancer. 2012 Apr 15;118(8 Suppl):2187-90. doi: 10.1002/cncr.27471. No abstract available.
citation: Stout NL, Andrews K, Binkley JM, Schmitz KH, Smith RA. Stakeholder perspectives on dissemination and implementation of a prospective surveillance model of rehabilitation for breast cancer treatment. Cancer. 2012 Apr 15;118(8 Suppl):2331-4. doi: 10.1002/cncr.27470.