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NCT Number: NCT03962595

Patient Satisfaction Survey (PSS) In Breast Clinic

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of patients having mean overall satisfaction score <70

    Time frame: 1 Year

    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.

  2. 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

    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

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

Assessment Of Patient Satisfaction Of Outpatient Care In The Multi-Disciplinary Breast Clinic- Linguistic Validation Study

Acronym: PSS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 24, 2019
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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