NCT01589406

Brief Summary

Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment (surgery or radiotherapy) and after completion of treatment in order to estimate the influence of disease and treatment on quality of life indices.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

April 29, 2012

Last Update Submit

May 1, 2012

Conditions

Cancer

Keywords

Gynaecological CancerQuality of LifeSexuality

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    longitudinal describtion of quality of life during treatment

    2 years

Study Arms (1)

group A group B

A:Patients for surgical intervention B:Patients for radiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with Gynaecological cancer

You may qualify if:

  • women with Gynaecological cancer intended to undergo chemotherapy or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

NeoplasmsSexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Amnon Amit, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2012

First Posted

May 2, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 2, 2012

Record last verified: 2012-04

Locations

IL(1)