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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Other: Telephone Follow-up

Detailed Description

The focus of the study is;

1. To generate an evidence-based checklist of signs and symptoms of recurrence of endometrial cancer.
2. 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.
3. To determine patients' satisfaction with the clinic and telephone follow-up.
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Telephone Follow-up; 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.

Other: Telephone Follow-up; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Queensland Centre for Gynaecological Cancer
• Investigators: Study Chair: Andreas Obermair, MD FRANZCOG CGO, Queensland Center for Gynecological Cancer; Study Director: Monika Janda, PhD, Queensland University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Endometrial cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: TEACUP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO