跳至主要内容
临床试验/CTRI/2023/03/051169
CTRI/2023/03/051169招募中不适用

To assess sexual relationships of female cancer survivors aged 20 to 60 yrs with their spouse post cancer treatment : A prospective observational study

HCG CANCER CENTRE NAGPUR1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年1月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
1
主要终点
sexual assessments

研究概览

简要总结

Introduction:

Now Cancer is considered as a chronic disease. [1]Undergoing cancer treatment is likely to cause some level of sexual dysfunction at some point during diagnosis, treatment, and/or long-term survival. Dysfunction may be due to the disease process, short- and long-term treatment-related side effects, problems with co-morbidities/their treatments, psychosocial issues including problems with relationships, psychological conditions, or concerns, or a combination of any of these factors. These problems can lead tovarious sexual issues , non intimate relationships and other discomfortness, loss of interest towards sexual pleasure etc. [2]

Talking with patients about their sexual health is laden with many fears and concerns.

The need for a comprehensive and problem specific asessment of patients for sexual issues associated with post treatment is felt by many reserachers.[2] In Indian scenario with cultural and ethical boundaries, talking about sex or sex related problems is still a taboo and so are not freely discussed.[3]

 Very few studies have been conducted so far hence the idea to conduct a study was conceptualised.

 Objectives

To assess sexual relationships of female cancer survivors aged 20 to 60 yrs with their spouse post cancer treatment.

 Ethics Committee Approval and CTRI registration:

The institutional ethics committee approval will be obtained before starting the study. CTRI registration will be done.

 Materials and Methods:

Study design: Single-center, prospective observational study

 Setting and participants:

Female cancer survivors with any type of cancer.

 **Subjects: Sample size:**82

Sampling method: A convenience sample

 Inclusion and Exclusion criteria:

 

Inclusion criteria

Exclusion Criteria

|Female Cancer survivors

Suffering from any severe psychiatric illness

|Age group 20years – 60 years

Those who are not sexually active

|

 Informed written concent will be obtained from the eligible Cancer Survivors who are willing to participate in the study. The concept of the study will be explained to the cancer survivors by audio visual method. The patients’ responses will be recorded by the interview technique by a Counsellor.

Measures:

The following questionnaires will be used for collecting the data.

· Demographic details of the Cancer Survivors: Psycho Assessment Form

· A questionnaire for structured interview: A questionnaire of 18 questions was prepared. Each question has responses ranging from 1 to 5, where 1=Not at all , 2=little bit, 3=Some what, 4=Very Much, and 5=Dont Know. The questionnaire was validated for its content by a panel of experts including a sexologist, a psychiatrist, a gynaecologist, a medical oncologist and an oncosurgeon.

  Duration of the study: Approximately 6 months

 Data Analysis:

Data will be analyzed using appropriate software and tests.

 Results: The results will be evaluated and interpreted and conclusions will be drawn.

 References:

  1. Phillips JL, Currow DC. Cancer as a chronic disease. Collegian. 2010 Jul 1;17(2):47-50.

2. Krebs LU. Sexual assessment in cancer care: concepts, methods, and strategies for success. InSeminars in oncology nursing 2008 May 1 (Vol. 24, No. 2, pp. 80-90). WB Saunders.

 3. Shankar A, Prasad N, Roy S, Chakraborty A, Biswas AS, Patil J, Rath GK. Sexual dysfunction in females after cancer treatment: an unresolved issue. Asian Pacific journal of cancer prevention: APJCP. 2017;18(5):1177.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • female cancer survivors age group 20 years to 60 years.

排除标准

  • suffering from any severe psychiatric illness those who are not sexually active.

结局指标

主要结局

sexual assessments

时间窗: 1 year after completion of cancer treatment

次要结局

  • Not applicable(Not applicable)

研究者

发起方
HCG CANCER CENTRE NAGPUR
申办方类型
Other [Corporate ]

研究点 (1)

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