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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01691144
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Heidi Lidal Fidjeland, University of Oslo

Brief Summary:
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 or disease
Endometrial Cancer Ovarian Cancer Cervical Cancer

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.

Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Gynecological Cancer Survivors` Views on Follow-up After Cancer Treatment
Study Start Date : September 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

recently treated patients
2-3 years after treatment

Primary Outcome Measures :
  1. Patient expectation questionnaire [ Time Frame: within the first 30 days after primary treatment ]
    The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care

Secondary Outcome Measures :
  1. Patient satisfaction questionnaire [ Time Frame: 3 years after treatment ]
    The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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

Inclusion Criteria:

  • > 18 years
  • histologically or cytologically proven cancer

Exclusion Criteria:

  • Unability to fill out questionnaires (due to language or cognitive barriers)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01691144

Sorlandet Hospital Kristiansand
Kristiansand, Norway, 4621
St. Olavs Hospital
Trondheim, Norway, 7030
Sponsors and Collaborators
University of Oslo
Study Chair: Mette Brekke, PhD University of Oslo

Responsible Party: Heidi Lidal Fidjeland, MD, University of Oslo Identifier: NCT01691144     History of Changes
Other Study ID Numbers: 2012/355B
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Heidi Lidal Fidjeland, University of Oslo:

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female