Breast CancerPSSNCT03962595
Patient Satisfaction Survey (PSS) In Breast Clinic
An observational study of Breast Cancer, run by Tata Memorial Centre at 1 site in India.
Trial summary
Patient satisfaction is the primary means of assessing the effectiveness of primary health care delivery. It helps in improving the quality of care by identifying and help resolving the potential problem areas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- How many people
- 340 participants
- Where
- 1 siteIndia
- Study dates
- 23 Jan 2017to 31 Dec 2019
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients attending both Private and General out-patient clinic for consultation will constitute the target population of the study.
Who may be able to join
- Women with histological confirmation of breast cancer.
- Planned to receive multi-disciplinary curative active cancer directed treatment.
- Aware of their diagnosis and treatment plan.
- Willingness to participate in study.
- Patient able to read and comprehend Hindi and Marathi. -
Who cannot join
- Eastern Cooperative Oncology Group 4
- Unable to read and fill the questionnaire -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Patient Satisfaction Of Outpatient Care In The Multi-Disciplinary Breast Clinic- Linguistic Validation Study
Patient satisfaction is the primary means of assessing the effectiveness of primary health care delivery. It helps in improving the quality of care by identifying and help resolving the potential problem areas. It assesses the effectiveness of the care provided and document the quality to accrediting organisations.In our institute, we have developed a patient satisfaction survey (PSS) questionnaire and have conducted a pilot study (Institutional review board approved) with fifty English speaking breast cancer patients receiving active cancer directed treatment in outpatient clinic, to evaluate the level of patient satisfaction in them. Therefore, we are now conducting a linguistic validation study using Hindi and Marathi PSS questionnaire to assess the overall level of patient satisfaction in a larger cohort of patients with diverse linguistic and economic background attending both general and private Outpatient Clinic.
The aim of the study is to evaluate the overall level of patient satisfaction and their satisfaction at various encounters in the multi-disciplinary Breast Clinic which can be helpful to improve various aspects of patient care delivery.
Read more
Methods:
All patients who have already sort primary consultation in surgical, medical and radiation oncology outpatient clinics for their treatment plan and have had their last consultation within the last one month will be screened for the study. The Patient Satisfaction Survey (PSS) questionnaire (in preferred language) will be administered independently by a clinical research student who is not directly involved in patient care. The PSS will be anonymous. It will be administered to patients in the out-patient clinics waiting area. Patients will be asked to complete 3 surveys: one each for surgical, medical and radiation oncology professionals. It will take approximately 12 months to enroll the required number of patients.
Sample size: Previous studies conducted in India and the pilot study conducted at Tata Memorial Hospital (TMH) with the PSS questionnaire have shown that approximately 70% of the patients are satisfied with the health care services. Assuming that the proportion of patients satisfied with the health services, when assessed by Hindi and Marathi PSS questionnaire will be ± 5% of 70%, i.e. between 65% to 75%, a sample size of 340 will be needed to produces a two-sided 95% confidence interval, which is determined by using Confidence Intervals Formula- Clopper-Pearson method.
Potential Impact of the Study
- Knowledge of patient satisfaction in breast cancer patients belonging to diverse linguistic and socio-economic background will help in improving the quality of life of patients using appropriate resources and measures relevant to Indian context.
- Awareness of patient dissatisfaction will help improve doctor patient relationship.
- Awareness of patient dissatisfaction will help to identify problem areas and improve the care delivery.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi.
Scoring: For each of the rated 25 items, a score of 1-5 will be assigned. This gives a maximum score of 125 and a minimum score of 25. A score of 75 or above indicates that patient is satisfied with the care provided.
Construct validity for the instrument will be assessed using Pearson's correlation between the items and scales (It-Sc i.e. convergent validity) and between scales (Sc-Sc i.e. discriminant validity). The correlation coefficient should be >0.4 and <0.7 for these respectively.
Internal consistency (scale reliability) of the multi item questionnaires will be tested by Cronbach alpha coefficient. The internal consistency should be 0.70 or higher when scales are used for group comparisons.
Measured: 1 Year
Secondary outcomes (2)
Proportion of patients having mean overall satisfaction score <70
The distribution of patients having low satisfaction score < 70 across surgical, medical and radiation oncology will be studied and the comments provided by patients will help understand the reasons related to low satisfaction.
Measured: 1 Year
To compare the level of overall patient satisfaction between paid and service patients: percentage of patients having overall score below 75 of the maximum 125
The comments provided by patients will help understand the reasons related to low satisfaction and the difference between the two classes of patients will be known from the percentage of patients having overall score below 70 of the maximum 125
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start23 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tabassum Wadasadawala, Tata Memorial Centre
- Investigators
- Dr. Tabassum Wadasadawala, MBBS,MD,DNB, Principal investigator, Associate Professor, Breast Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962595
- Sponsor's protocol ID
- 1835
- Acronym
- PSS
- Status last verified
- Apr 2025
- First submitted
- 1 May 2019
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Patient Satisfaction Of Outpatient Care In The Multi-Disciplinary Breast Clinic- Linguistic Validation Study
- ClinicalTrials.gov ID
- NCT03962595
- Acronym / sponsor ID
- PSS / 1835
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 May 2019 (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.
Patient satisfaction is the primary means of assessing the effectiveness of primary health care delivery. It helps in improving the quality of care by identifying and help resolving the potential problem areas. It assesses the effectiveness of the care provided and document the quality to accrediting organisations.In our institute, we have developed a patient satisfaction survey (PSS) questionnaire and have conducted a pilot study (Institutional review board approved) with fifty English speaking breast cancer patients receiving active cancer directed treatment in outpatient clinic, to evaluate the level of patient satisfaction in them. Therefore, we are now conducting a linguistic validation study using Hindi and Marathi PSS questionnaire to assess the overall level of patient satisfaction in a larger cohort of patients with diverse linguistic and economic background attending both general and private Outpatient Clinic.
The aim of the study is to evaluate the overall level of patient satisfaction and their satisfaction at various encounters in the multi-disciplinary Breast Clinic which can be helpful to improve various aspects of patient care delivery.
Methods:
All patients who have already sort primary consultation in surgical, medical and radiation oncology outpatient clinics for their treatment plan and have had their last consultation within the last one month will be screened for the study. The Patient Satisfaction Survey (PSS) questionnaire (in preferred language) will be administered independently by a clinical research student who is not directly involved in patient care. The PSS will be anonymous. It will be administered to patients in the out-patient clinics waiting area. Patients will be asked to complete 3 surveys: one each for surgical, medical and radiation oncology professionals. It will take approximately 12 months to enroll the required number of patients.
Sample size: Previous studies conducted in India and the pilot study conducted at Tata Memorial Hospital (TMH) with the PSS questionnaire have shown that approximately 70% of the patients are satisfied with the health care services. Assuming that the proportion of patients satisfied with the health services, when assessed by Hindi and Marathi PSS questionnaire will be ± 5% of 70%, i.e. between 65% to 75%, a sample size of 340 will be needed to produces a two-sided 95% confidence interval, which is determined by using Confidence Intervals Formula- Clopper-Pearson method.
Potential Impact of the Study
- Knowledge of patient satisfaction in breast cancer patients belonging to diverse linguistic and socio-economic background will help in improving the quality of life of patients using appropriate resources and measures relevant to Indian context.
- Awareness of patient dissatisfaction will help improve doctor patient relationship.
- Awareness of patient dissatisfaction will help to identify problem areas and improve the care delivery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients attending both Private and General out-patient clinic for consultation will constitute the target population of the study.
Key inclusion criteria (5 listed)
- Women with histological confirmation of breast cancer.
- Planned to receive multi-disciplinary curative active cancer directed treatment.
- Aware of their diagnosis and treatment plan.
- Willingness to participate in study.
- Patient able to read and comprehend Hindi and Marathi. -
Key exclusion criteria (2 listed)
- Eastern Cooperative Oncology Group 4
- Unable to read and fill the questionnaire -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi.
Time frame: 1 Year
Scoring: For each of the rated 25 items, a score of 1-5 will be assigned. This gives a maximum score of 125 and a minimum score of 25. A score of 75 or above indicates that patient is satisfied with the care provided. Construct validity for the instrument will be assessed using Pearson's correlation between the items and scales (It-Sc i.e. convergent validity) and between scales (Sc-Sc i.e. discriminant validity). The correlation coefficient should be >0.4 and <0.7 for these respectively. Internal consistency (scale reliability) of the multi item questionnaires will be tested by Cronbach alpha coefficient. The internal consistency should be 0.70 or higher when scales are used for group comparisons.
2 secondary outcomes
Proportion of patients having mean overall satisfaction score <70
Time frame: 1 Year
To compare the level of overall patient satisfaction between paid and service patients: percentage of patients having overall score below 75 of the maximum 125
Time frame: 1Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Sitzia J, Wood N. Patient satisfaction: A review of issues and concepts. Social Science and Medicine. 1997;45(12):1829-43.Link provided by the sponsor.
- Mendoza Aldana J, Piechulek H, al-Sabir A. Client satisfaction and quality of health care in rural Bangladesh. Bulletin of the World Health Organization. 2001; 79:512-7.Link provided by the sponsor.
- Lis CG, Rodeghier M, Gupta D. Distribution and determinants of patient satisfaction in oncology: A review of the literature. Patient Preference and Adherence. 2009;(3):287-Link provided by the sponsor.
- Landen CN, Younger NO, Collins Sharp B a., Underwood PB. Cancer patients' satisfaction with physicians: Princess Margaret hospital satisfaction with doctor questionnaire results. American Journal of Obstetrics and Gynecology. 2003 May;188(5):1177-9.Link provided by the sponsor.
- Bergenmar M, Nylén U, Lidbrink E, Bergh J, Brandberg Y. Improvements in patient satisfaction at an outpatient clinic for patients with breast cancer. Acta oncologica (Stockholm, Sweden). 2006 Jan;45(5):550-8.Link provided by the sponsor.
- Brown RF, Hill C, Burant CJ, Siminoff L A. Satisfaction of early breast cancer patients with discussions during initial oncology consultations with a medical oncologist. Psycho-oncology. 2009 Jan;18(1):42-9.Link provided by the sponsor.
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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.
Dr. Tabassum Wadasadawala, MBBS,MD,DNB principal investigator
Associate Professor, Breast Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Tata Memorial Centre at 1 site in India.
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 2 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: finished, as of the sponsor's last update on 10 Apr 2025. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linguistic validation of patient satisfaction survey (PSS) questionnaires in Hindi and Marathi. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.