Patient Satisfaction Survey (PSS) In Breast Clinic

NCT03962595 | Completed DMC

• 1 other identifier: 1835
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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

1. 1.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.
2. 2.Awareness of patient dissatisfaction will help improve doctor patient relationship.
3. 3.Awareness of patient dissatisfaction will help to identify problem areas and improve the care delivery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Year

Secondary Outcomes (2)

• Proportion of patients having mean overall satisfaction score <70

  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

  1Year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients attending both Private and General out-patient clinic for consultation will constitute the target population of the study.

You may qualify if:

• 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. -

You may not qualify if:

• Eastern Cooperative Oncology Group 4
• Unable to read and fill the questionnaire -

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

Related Links

• Sitzia J, Wood N. Patient satisfaction: A review of issues and concepts. Social Science and Medicine. 1997;45(12):1829-43.
• 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.
• Sharma A, Kasar PK, Sharma R. Patient satisfaction about hospital services: a study from the outpatient department of tertiary care hospital, Jabalpur, Madhya Pradesh, India. National Journal of Community Medicine. 2014;5(2):199-203.
• 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-
• 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.
• 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.
• 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Tabassum Wadasadawala, MBBS,MD,DNB

  Associate Professor, Breast Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiation Oncology, Breast Services

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 24, 2019
• Study Start: January 23, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

IN (1)