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临床试验/CTRI/2024/02/063368
CTRI/2024/02/063368尚未招募不适用

Concerns in Breast Cancer Survivors with respect to Sexual Function,Sexual Satisfaction and Distress: A Sequential Explanatory Study

Malabar Cancer Centred1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2024年3月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
115
试验地点
1
主要终点
Assessing the Sexual Function and Sexual Satisfaction and distress of Breast Cancer Survivors and understanding their sexual concerns from the

研究概览

简要总结

This study aims to identify the level of sexual function and sexual distress among Breast

cancer Survivors and to better understand their individualistic sexual concerns from the

perspective of the survivor, their partner. The study will also provide an insight into the

sexual concerns of Breast cancer Survivors from the perspective of oncologists.

The primary objectives of the study are to assess the Sexual Function, Sexual Satisfaction and

Distress among Breast Cancer Survivors and to better understand the sexual concerns of

Breast Cancer Survivors from the perspective of the survivors, their partners, and the

oncologists. The study is a mixed method study using Sequential Explanatory method - both

Quantitative and Qualitative research methods in a sequential manner. The sample size for the

descriptive study is 115 Breast Cancer Survivors belonging to the age group of 21-65 years

and have completed curative intent treatment for Breast Cancer in Malabar Cancer Centre.

The data for the qualitative part of the study will be conducted until data saturation. The tools

Female Sexual Function Index (FSFI) and Sexual Satisfaction Scale (SSS) will be used for

the quantitative part of the study. The qualitative data will be collected using a semi

structured interview.

The inclusion criteria for the quantitative study are Married/live-in women, living with

Partner for the last 2 months, Completed at least 6 months after curative intent treatmentfor

breast cancer (Stage I, II, III), Should have been sexually active before diagnosis, Can read,

speak, and understand either English or Malayalam. Those with known history of psychiatric

illness or neurological disorder, relapse, recurrence, or second primary, metachronous

Bilateral Breast Cancer will be excluded. The survivors who secured a score less than 55 in

FSFI is eligible for qualitative study. Partners of the participant included in the qualitative

study who can read, speak, and understand either English or Malayalam will be eligible.

Consultant Surgical Oncologists, Gynaec-Oncologists, Medical Oncologists,Radiation

Oncologists with an experience of treating breast cancer patients and a minimum 2 years of

experience at Cancer Centers will be eligible for qualitative study.

Descriptive Statistical techniques such as the Mean, Standard deviation, Correlation

coefficient and one way analysis of variance (ANOVA) will be used to analyse the

quantitative data. The descriptive data collected from the participants through in-depth

interview will be analysed using, thematic analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria for quantitative study: 1-Married/live-in women, living with Partner for the last 2 months 2-Completed at least 6 months after curative intent treatment for breast cancer (Stage I, II, III) 3-Should have been sexually active before diagnosis 4-Can read, speak, and understand either English or Malayalam Eligibility of survivor to include in Qualitative study: 1-FSFI score less than 55 2-Partner present during the study 3-Living with this Partner for the last two months Eligibility of partner to include in the qualitative study: 1-Partner of the participant included in the qualitative study 2-Partner Can read, speak, and understand either English or Malayalam Eligibility of Oncologist to include in the qualitative study: 1-Consultant Surgical Oncologists, Gynaec-Oncologists, Medical Oncologists, Radiation Oncologists.
  • 2-Experience of treating breast cancer patients.
  • 3-minimum 2 years of experience at Cancer Centre.

排除标准

  • Exclusion Criteria for quantitative study: ● Participants with history of psychiatric illness or neurological disorder.
  • ● Participants with a relapse, recurrence, or second primary, metachronous Bilateral Breast Cancer.

结局指标

主要结局

Assessing the Sexual Function and Sexual Satisfaction and distress of Breast Cancer Survivors and understanding their sexual concerns from the

时间窗: Minimum of 6 months after curative intent treatment

perspective of the survivors, their partners and the oncologists.

时间窗: Minimum of 6 months after curative intent treatment

次要结局

  • To find the relationship between Sexual Function and Sexual Satisfaction and Distress among Breast Cancer Survivors(Minimum of 6 months after curative intent treatment)

研究者

发起方
Malabar Cancer Centred
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jisha Abraham

Malabar Cancer Centre

研究点 (1)

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