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Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors

Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06406868
Enrollment
44
Registered
2024-05-09
Start date
2024-02-07
Completion date
2024-06-14
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Shoulder Functional Independece

Brief summary

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

Detailed description

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.

Interventions

OTHERAmerican 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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain and Disability Index (SPADI)3rd dayChanges 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.

Secondary

MeasureTime frameDescription
Breast Cancer Therapy Functional Rating Scale (FACT-B)3rd dayChanges from baseline are taken FACT-B assesses the various domains such as, Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being, and Additional concerns specific to breast cancer patients.Score ranges from 0 to 148, with 148 a good score
Goniometer3rd dayChanges from baseline ROM of shoulder was taken with the help of goniometer

Countries

Pakistan

Contacts

Primary ContactImran Amjad, PHD
imran.amjad@riphah.edu.pk03324390125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026