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Telephone Follow-up After Treatment for Endometrial Cancer.


N/A
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

Telephone Follow-up After Treatment for Endometrial Cancer.


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Andreas Obermair, MD FRANZCOG CGO

Investigator Role:

Study Chair

Investigator Affiliation:

Queensland Center for Gynecological Cancer

Authority:

Australia: Human Research Ethics Committee

Study ID:

TEACUP

NCT ID:

NCT01610375

Start Date:

June 2012

Completion Date:

November 2014

Related Keywords:

  • Endometrial Cancer
  • Endometrial cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

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