Skip to main content
OpenTrials
Completed

NCT Number: NCT01610375

Telephone Follow-up After Treatment for Endometrial Cancer

The aim of this study is to investigate the feasibility, safety and accuracy of a telephone follow-up for women previously treatment for endometrial cancer.

To achieve this aim, potentially eligible women attending the Queensland Centre for Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for endometrial cancer will be recruited by this study. The study aims to recruit all new patients as well as all patients who return to QCGC for their follow-up and who had treatment within the previous 2 years.

The proposed project will involve generation of an evidence-based checklist of signs and symptoms of disease recurrence from a thorough literature review. The generated symptom checklist will be pilot tested and the refined symptom checklist will be used to follow study participants over a period of 12 months.

During the follow-up period, the basic standard of follow-up after primary treatment for endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be altered; however, the study participants will be interview via telephone 2 to 5 days prior to their scheduled review dates.

The main outcome measure will be the estimated recurrence rate as derived from the telephone assessment and this will be compared to the clinically detected recurrences as recorded in patients' medical files.

It is hypothesized, that the telephone follow-up will identify 90% of all recurrences correctly that are later confirmed during the clinical follow-up.

In addition to the main outcome, we will also assess patients' satisfaction with each of the follow-up programs, whether or not lifestyle behaviours were queried and support offered to improve wellbeing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

About this study

The focus of the study is;

  • To generate an evidence-based checklist of signs and symptoms of recurrence of endometrial cancer.
  • To assess the sensitivity and specificity of a telephone follow-up compared to the current clinic-based follow-up in the detection of recurrence of endometrial cancer.
  • To determine patients' satisfaction with the clinic and telephone follow-up.
  • To assess patients' self reported well being (physical activity, smoking, diet, anxiety, depression and quality of life).

The proposed project will involve generation of an evidence-based checklist of signs and symptoms of recurrence. The generated symptom checklist will be used to follow study participants over a period of 12 months.

During the follow-up period, patients' routine clinic follow-up schedules will not be altered, however; the study participants will be interviewed via telephone 2 to 5 days prior to their scheduled clinic visits dates. The checklist of signs and symptoms generated by this study will form the basis for this interview.

In addition, we will also enquire about the participant's wellbeing and provide resources on physical activity, diet and other life style behaviours and supportive care when needed.

The data analysis will include determining:

i. Sensitivity- Proportion of those with the condition who have a positive test.

ii. Specificity-Proportion of those without the condition who have a negative test.

iii. Positive predictive value (PV+) - Proportion of those with a positive test who have the condition.

iv. Negative predictive value (PV-) - Proportion of those with a negative test who do not have the condition.

Overall accuracy of the symptom checklist compared to the clinic-based follow-up program will also be calculated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

To be eligible for this pilot study, the patient must;

  • Have completed primary treatment for endometrial cancer
  • Be recurrence-free
  • In the first to third year after treatment
  • Be able to read and understand English
  • Must have access to a telephone and adequate hearing
  • Participants must be willing to complete questionnaire on satisfaction with nurse and clinic follow-up

Exclusion criteria

  • Patients with disease recurrent or relapse
  • Patients with metastatic disease presentation

Treatment and study plan

Telephone Follow-up

Other

This is a non-randomised observational study to assess the value of a symptom checklist to detect recurrence in women with endometrial cancer. Women will be telephoned using an evidence-based symptom checklist in parallel to the standard clinic-based follow-up. The researcher will call the participants 2 to 5 days prior to their scheduled clinic review dates to enquire about the presence of symptoms which may be indicative of disease recurrence. In addition, the researcher will also enquire about the participants' wellbeing and provide standard lifestyle resource on physical activity, diet and other lifestyle behaviours and supportive care when needed.

Other names: TEACUP

Primary outcomes

  1. Sensitivity, specificity and overall accuracy of the telephone follow-up compared to clinic-based follow-up and patients' satisfaction.

    Time frame: 12 months

    The proposed project will involve generation of an evidence-based checklist of signs and symptoms of recurrence from a thorough literature review. The generated symptom checklist will be pilot tested and used in a one year prospective cohort study.

Secondary outcomes

  1. Changes in lifestyle behaviours and quality of life overtime.

    Time frame: 12 months

    The researcher will conduct a telephone interview and will enquire about the participant's wellbeing and provide resources on physical activity, quality of life, diet, anxiety and depression and supportive care when needed prior to each clinic visit.

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Registry information

Official study title

Telephone Follow-up After Treatment for Endometrial Cancer.

Acronym: TEACUP

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Jun 4, 2012
Registry last updated
Aug 29, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.