Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer

NCT ID: NCT02754427

Last Updated: 2019-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-08-31

Brief Summary

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Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prospective Surveillance Group

Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.

Group Type EXPERIMENTAL

Prospective Surveillance Group

Intervention Type BEHAVIORAL

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.

Education Group

Participants in the education group received the usual post-operative follow-up.

Group Type ACTIVE_COMPARATOR

Education Group

Intervention Type BEHAVIORAL

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.

Interventions

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Prospective Surveillance Group

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.

Intervention Type BEHAVIORAL

Education Group

Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prospective surveillance for arm morbidity and physiotherapy treatment Attention Control Group

Eligibility Criteria

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Inclusion Criteria

* age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.

Exclusion Criteria

* prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion \<75% of non-affected side; or a diagnosis of primary lymphedema
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Kristin Campbell

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Other Identifiers

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H12-01773

Identifier Type: -

Identifier Source: org_study_id

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