Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain
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|ClinicalTrials.gov Identifier: NCT04080934|
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : May 31, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Seroma Pain, Postoperative Pain, Chest||Behavioral: Swimming||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain|
|Estimated Study Start Date :||September 1, 2022|
|Estimated Primary Completion Date :||August 21, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Experimental Group
In the experimental group, patients allocated to the swimming/experimental group will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum. They will be asked to undergo a range of motion (ROM) assessment by a registered kinesiologist, as well as a few short questionnaires administered over the phone by a research assistant, once at the onset of the intervention and once a month for 3 months during the intervention.
Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.
No Intervention: Control Group
The control group will include patients who receive standard of care. This includes the recommendation to undertake exercise and physiotherapy; however, no formal exercise program will be provided. In the control group, participants will be asked to answer a few short questionnaires administered over the phone by a research assistant once per month for 4 months.
- Post-operative pain following breast cancer [ Time Frame: The primary measure will be calculated after swimming is completed. This will last approximately 14 months. ]The primary outcome will be pain as assessed using a visual analog scale (VAS). The VAS scale is a 100mm-long horizontal line with the word "no pain" at one end and "pain as bad as it can be" at the other. This will be pain levels of patients after the swimming program in comparison with the control group who will receive no swimming program.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Eligible participants include adult female patients, 18 years of age or higher, from the Ottawa Hospital who are post-operative from a lumpectomy or a mastectomy with or without full axillary dissection and radiation. They will be less than 3 years from completion of their acute cancer treatment. Study subjects must have pain symptoms related to chest wall pain and/or arm morbidity, seroma or lymphedema. They must have approval from their medical and radiation oncologist to participate in the study upon enrollment.
- Patients with ongoing medical problems where swimming would be contraindicated will be excluded from this study. Those who swam on a regular basis prior to their breast cancer diagnosis will be excluded from the study, as well as those who cannot swim, due to safety concerns and limited resources/time required to complete more in-depth swimming instruction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080934
|Contact: Natalie Mills, MDfirstname.lastname@example.org|
|Principal Investigator:||Natalie Mills, MD||Univeristy of Ottawa|
|Responsible Party:||Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||September 6, 2019 Key Record Dates|
|Last Update Posted:||May 31, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|