search
Back to results

Telephone Follow-up After Treatment for Endometrial Cancer (TEACUP)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Telephone Follow-up
Sponsored by
Queensland Centre for Gynaecological Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Endometrial Cancer focused on measuring Endometrial cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brisbane and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Telephone Follow-up

Arm Description

Women previously treated for endometrial cancer will be recruited into one study group and continue to be followed per the current routine clinic follow-up. However, an additional program (telephone follow-up) will be offered in parallel to the current clinic follow-up. Outcomes obtained from the telephone follow-up will be compared with the current clinical assessment.

Outcomes

Primary Outcome Measures

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

Changes in lifestyle behaviours and quality of life overtime.
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.

Full Information

First Posted
March 22, 2012
Last Updated
August 26, 2019
Sponsor
Queensland Centre for Gynaecological Cancer
search

1. Study Identification

Unique Protocol Identification Number
NCT01610375
Brief Title
Telephone Follow-up After Treatment for Endometrial Cancer
Acronym
TEACUP
Official Title
Telephone Follow-up After Treatment for Endometrial Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queensland Centre for Gynaecological Cancer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Follow-up
Arm Type
Other
Arm Description
Women previously treated for endometrial cancer will be recruited into one study group and continue to be followed per the current routine clinic follow-up. However, an additional program (telephone follow-up) will be offered in parallel to the current clinic follow-up. Outcomes obtained from the telephone follow-up will be compared with the current clinical assessment.
Intervention Type
Other
Intervention Name(s)
Telephone Follow-up
Other Intervention Name(s)
TEACUP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity, specificity and overall accuracy of the telephone follow-up compared to clinic-based follow-up and patients' satisfaction.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in lifestyle behaviours and quality of life overtime.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Obermair, MD FRANZCOG CGO
Organizational Affiliation
Queensland Center for Gynecological Cancer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Monika Janda, PhD
Organizational Affiliation
Queensland University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telephone Follow-up After Treatment for Endometrial Cancer

We'll reach out to this number within 24 hrs