Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

NCT06406868 | Recruiting

• 1 other identifier: REC/01729 Qurat ul ain Khan
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Shoulder Functional Independece

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  Changes from baseline are taken shoulder pain disability index is developed to measure shoulder functional independence.It contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Score ranges from 0 to 100, with higher scores indicating greater shoulder pain and disability.

  3rd day

Secondary Outcomes (2)

• Breast Cancer Therapy Functional Rating Scale (FACT-B)

  3rd day

• Goniometer

  3rd day

Study Arms (2)

Telerehablitation

EXPERIMENTAL

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

Other: American Cancer Society

Outpatient Rehablitation

ACTIVE COMPARATOR

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

Other: American Cancer Society

Interventions

American Cancer Society 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; Telerehablitation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Breast cancer mostly affects females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Nishtar Hospital

Multan Khurd, Punjab Province, 66000, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 28969709 BACKGROUND

• 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.

  PMID: 31083196 BACKGROUND

• 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.

  PMID: 28331675 BACKGROUND

• 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.

  PMID: 30030037 BACKGROUND

• 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.

  PMID: 26001890 BACKGROUND

• 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.

  PMID: 21922244 BACKGROUND

• 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.

  PMID: 32492064 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

American Cancer Society

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Voluntary Health Agencies; Organizations, Nonprofit; Organizations; Health Care Economics and Organizations

Study Officials

• Qurat ul ain Khan, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: February 7, 2024
• Primary Completion: June 7, 2024
• Study Completion: June 14, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)