Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

NCT ID: NCT06406868

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-06-14

Brief Summary

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This study is comparing two interventions to identify effective treatment for breast cancer patients.

Detailed Description

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Tele rehabilitation has gained popularity during Covid 19 pandemic. All the studies carried out at that time was found effective in many countries. Still a literature gap is present in tele rehabilitation in breast cancer patients in Pakistan. Prevalence of breast cancer is high in Pakistan. Now it is the best time to implement tele rehabilitation for breast cancer patients as it will reduce treatment costs and travel expenses. Therefore, the goal of this RCT is to consider tele rehabilitation as part of our treatment plan because if it is found effective for patients than it will be helpful in the field of health and technology.

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

DOUBLE

Participants Investigators

Study Groups

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Telerehablitation

The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients.

Frequency :10 repetitions Intensity: Moderate Time: Once a day

Group Type EXPERIMENTAL

American Cancer Society

Intervention Type OTHER

After taking base line readings the patients will be divided into two groups' experimental group and control group by randomization. The experimental group will receive tele rehabilitation and the control group will receive outpatient rehabilitation. Readings will be taken at the end of every week. The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. The exercise plan will start on third day of surgery. A pictorial reference will be given to every patient to perform exercise.

The exercise session will be thrice a week, for 60 min, and for four consecutive weeks, for 12 sessions. Exercise plan consists of three phases:

warm up, balance exercise ,cool down

Outpatient Rehablitation

The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients.

Frequency :10 repetitions Intensity: Moderate Time: Once a day

Group Type ACTIVE_COMPARATOR

American Cancer Society

Intervention Type OTHER

After taking base line readings the patients will be divided into two groups' experimental group and control group by randomization. The experimental group will receive tele rehabilitation and the control group will receive outpatient rehabilitation. Readings will be taken at the end of every week. The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. The exercise plan will start on third day of surgery. A pictorial reference will be given to every patient to perform exercise.

The exercise session will be thrice a week, for 60 min, and for four consecutive weeks, for 12 sessions. Exercise plan consists of three phases:

warm up, balance exercise ,cool down

Interventions

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American Cancer Society

After taking base line readings the patients will be divided into two groups' experimental group and control group by randomization. The experimental group will receive tele rehabilitation and the control group will receive outpatient rehabilitation. Readings will be taken at the end of every week. The treatment plan of both groups will be the same according to the exercise plan given by American Cancer Society guidelines for breast cancer patients. The exercise plan will start on third day of surgery. A pictorial reference will be given to every patient to perform exercise.

The exercise session will be thrice a week, for 60 min, and for four consecutive weeks, for 12 sessions. Exercise plan consists of three phases:

warm up, balance exercise ,cool down

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 30 to 60 years.
* Breast Cancer Females who underwent mastectomy (Simple total mastectomy).
* Breast Cancer Females without chemotherapy or radiotherapy treatment.
* Accessibility to smart phone.
* Internet access.

Exclusion Criteria

* Previous history of breast or any other cancer.
* Females with metastatic breast cancer.
* Any Chronic pathology that will result in an increase in symptoms due to physical exercise.
* Any contraindications limiting physical activity.
* Shoulder radiculopathy, or fracture.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qurat ul ain Khan, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Nishtar Hospital

Multan Khurd, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Amjad, PHD

Role: CONTACT

03324390125

Facility Contacts

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Qurat-ul-ain Khan, MS

Role: primary

0315 5246605

References

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Akram M, Iqbal M, Daniyal M, Khan AU. Awareness and current knowledge of breast cancer. Biol Res. 2017 Oct 2;50(1):33. doi: 10.1186/s40659-017-0140-9.

Reference Type BACKGROUND
PMID: 28969709 (View on PubMed)

Lee CH, Chung SY, Kim WY, Yang SN. Effect of breast cancer surgery on chest tightness and upper limb dysfunction. Medicine (Baltimore). 2019 May;98(19):e15524. doi: 10.1097/MD.0000000000015524.

Reference Type BACKGROUND
PMID: 31083196 (View on PubMed)

Akca M, Ata A, Nayir E, Erdogdu S, Arican A. Impact of Surgery Type on Quality of Life in Breast Cancer Patients. J Breast Health. 2014 Oct 1;10(4):222-228. doi: 10.5152/tjbh.2014.1919. eCollection 2014 Oct.

Reference Type BACKGROUND
PMID: 28331675 (View on PubMed)

van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.

Reference Type BACKGROUND
PMID: 30030037 (View on PubMed)

Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y.

Reference Type BACKGROUND
PMID: 26001890 (View on PubMed)

Ng R, Lee CF, Wong NS, Luo N, Yap YS, Lo SK, Chia WK, Yee A, Krishna L, Goh C, Cheung YB. Measurement properties of the English and Chinese versions of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in Asian breast cancer patients. Breast Cancer Res Treat. 2012 Jan;131(2):619-25. doi: 10.1007/s10549-011-1764-z. Epub 2011 Sep 16.

Reference Type BACKGROUND
PMID: 21922244 (View on PubMed)

Rasmussen GHF, Kristiansen M, Arroyo-Morales M, Voigt M, Madeleine P. Absolute and relative reliability of pain sensitivity and functional outcomes of the affected shoulder among women with pain after breast cancer treatment. PLoS One. 2020 Jun 3;15(6):e0234118. doi: 10.1371/journal.pone.0234118. eCollection 2020.

Reference Type BACKGROUND
PMID: 32492064 (View on PubMed)

Other Identifiers

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REC/01729 Qurat ul ain Khan

Identifier Type: -

Identifier Source: org_study_id

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