NCT01060761

Brief Summary

The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together). The study evaluate the effect of the program compared to no intervention (usual care)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 6, 2017

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

February 1, 2010

Last Update Submit

November 2, 2017

Conditions

RehabilitationCancerRelatives

Keywords

cancerRehabilitation program (patient and a relative together)counsellingretreat weekend

Outcome Measures

Primary Outcomes (1)

  • Quality of life,

    two months and one year

Study Arms (2)

Rehabilitation program

ACTIVE COMPARATOR

Counselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together)

Behavioral: Rehabilitation program

Ususal treatment and support

NO INTERVENTION

Usual support and treatment at the hospital, no retreat Weekend.

Interventions

Rehabilitation programBEHAVIORAL

Patient and their relative receive three supportive, structured conversation with a trained nurse. Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities

Also known as: KRIPP project
Rehabilitation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both the patient and their relative must agree to participate together
  • Patient admitted to the Hospital
  • Patient admitted with a lung cancer diagnosis or
  • Patient admitted with a gynecological cancer diagnosis

You may not qualify if:

  • The cancer diagnosis was not verified.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Helle P Hansen, Professor

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

November 6, 2017

Record last verified: 2012-06

Locations

DK(1)