Telephone Follow-up After Treatment for Endometrial Cancer

NCT01610375 | Completed

• 1 other identifier: TEACUP
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in lifestyle behaviours and quality of life overtime.

  12 months

Study Arms (1)

Telephone Follow-up

OTHER

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

Interventions

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.

Also known as: TEACUP

Telephone Follow-up

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead

Study Sites (1)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andreas Obermair, MD FRANZCOG CGO

  Queensland Center for Gynecological Cancer

  STUDY CHAIR

• Monika Janda, PhD

  Queensland University of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: June 4, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)