Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by University of Oslo
Sponsor:
Information provided by (Responsible Party):
Heidi Lidal Fidjeland, University of Oslo
ClinicalTrials.gov Identifier:
NCT01691144
First received: August 15, 2012
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

Follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. In some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. In this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. Further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. In addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. The investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.


Condition
Endometrial Cancer
Ovarian Cancer
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Follow-up of Gynecological Cancer Patients. Their Needs and Expectations. A Cooperation Project.

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Patient expectation questionnaire [ Time Frame: within the first 30 days after primary treatment ] [ Designated as safety issue: No ]
    The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care


Secondary Outcome Measures:
  • Patient satisfaction questionnaire [ Time Frame: 3 years after treatment ] [ Designated as safety issue: No ]
    The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
recently treated patients
2-3 years after treatment

Detailed Description:

After gynaecological cancer patients have completed their treatment, they are followed up at a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to detect recurrence, improve survival and reduce adverse effects of the treatment. The national guide for oncological gynaecology recommends follow-up by a specialist for five years at intervals depending on cancer type. Several review studies on follow-up of endometrial, cervical and ovarian cancer patients show large international variations in follow-up routines. There are only retrospective studies available, and they indicate that most recurrences are discovered within the first three years after completed treatment, and, in most cases, by the women themselves. More intensive surveillance does not appear to affect the time for discovery of recurrence.

A few randomised controlled studies and retrospective cohort studies have been published that focus on follow-up of colon cancer and breast cancer patients by general practitioners versus by hospital specialists. These studies have not shown any significant differences between the groups in terms of detection of recurrence, incidence of serious clinical events connected with recurrence or health-related quality of life.

The investigators therefore plan to perform a study in which both gynaecological cancer patients and their regular general practitioners are asked about their views on patient follow-up after completed treatment. The investigators especially wish to focus on the collaboration aspect.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Newly treated gynecological cancer patients and patients treated 2-3 years ago

Criteria

Inclusion Criteria:

  • > 18 years
  • histologically or cytologically proven cancer

Exclusion Criteria:

  • Unability to fill out questionnaires (due to language or cognitive barriers)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691144

Contacts
Contact: Ingvild Vistad, PhD 4738074050 ingvild.vistad@sshf.no
Contact: Mette Brekke, PhD

Locations
Norway
Sorlandet Hospital Kristiansand Not yet recruiting
Kristiansand, Norway, 4621
Contact: Ingvild Vistad, PhD         
Contact: Mette Brekke, PhD         
Sub-Investigator: Ingvild Vistad, PhD         
Sponsors and Collaborators
University of Oslo
Investigators
Study Chair: Mette Brekke, PhD University of Oslo
  More Information

Publications:
Responsible Party: Heidi Lidal Fidjeland, MD, University of Oslo
ClinicalTrials.gov Identifier: NCT01691144     History of Changes
Other Study ID Numbers: 2012/355B
Study First Received: August 15, 2012
Last Updated: September 21, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
cancer
gynecological
expectations
satisfaction
cooperation

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 29, 2014