Breast CancerNCT06406868
Outpatient Versus Tele Rehabilitation Among Post-surgical Breast Cancer Survivors
A study testing American Cancer Society in people with Breast Cancer, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is comparing two interventions to identify effective treatment for breast cancer patients. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- American Cancer Society
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Feb 2024to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Hospital
Multan Khurd, Punjab Province, 66000
Qurat-ul-ain Khan, MS, 0315 5246605, quratulain.ggc@riphah.edu.pk
Leena Shakeel, MS-WHPT
About this study
Official title: Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors
This study is comparing two interventions to identify effective treatment for breast cancer patients.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- American Cancer Society
- Keywords
- Shoulder Functional Independece
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Cancer SocietyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: American Cancer Society |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd day
Secondary outcomes (2)
Breast Cancer Therapy Functional Rating Scale (FACT-B)
Changes 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
Measured: 3rd day
Goniometer
Changes from baseline ROM of shoulder was taken with the help of goniometer
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start7 Feb 2024
- Primary completion7 Jun 2024 (estimated)
- Study completion14 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul ain Khan, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406868
- Sponsor's protocol ID
- REC/01729 Qurat ul ain Khan
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28969709Lee 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.
PubMed 31083196Akca 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.
PubMed 28331675van 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.
PubMed 30030037Torres-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.
PubMed 26001890Ng 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.
PubMed 21922244Rasmussen 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.
PubMed 32492064
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Outpatient Versus Tele Rehabilitation on Shoulder Functional Independence Among Post-surgical Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06406868
- Acronym / sponsor ID
- REC/01729 Qurat ul ain Khan
- Conditions
- Breast Cancer
- Keywords
- Shoulder Functional Independece
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Jun 2024 (estimated)
- Study completion
- 14 Jun 2024 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehablitation | Experimental | Other: American Cancer SocietyThe 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 |
| Outpatient Rehablitation | Active comparator | Other: American Cancer SocietyThe 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American Cancer SocietyAfter 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 | Other | Outpatient Rehablitation, Telerehablitation |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 3rd day
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.
2 secondary outcomes
Breast Cancer Therapy Functional Rating Scale (FACT-B)
Time frame: 3rd day
Goniometer
Time frame: 3rd day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 28969709Akram 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.
- Background: PubMed 31083196Lee 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.
- Background: PubMed 28331675Akca 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.
- Background: PubMed 30030037van 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.
- Background: PubMed 26001890Torres-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.
- Background: PubMed 21922244Ng 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.
- Background: PubMed 32492064Rasmussen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qurat ul ain Khan, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing American Cancer Society in people with Breast Cancer, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: 3rd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06406868, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.