Involvement of Patients and Relatives in the Course of Cancer Disease

NCT ID: NCT01060761

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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)

Detailed Description

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The study aim to evaluate the effect and the benefit of the program.

First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)

The effect is also assessed in qualitative interviews with patients and their relatives.

The rehabilitation course is investigated in qualitative observations and interviews.

Conditions

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Rehabilitation Cancer Relatives

Keywords

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cancer Rehabilitation program (patient and a relative together) counselling retreat weekend

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Rehabilitation program

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

Group Type ACTIVE_COMPARATOR

Rehabilitation program

Intervention Type BEHAVIORAL

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

Ususal treatment and support

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rehabilitation program

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

Intervention Type BEHAVIORAL

Other Intervention Names

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KRIPP project

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* The cancer diagnosis was not verified.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Helle Ploug Hansen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle P Hansen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HMS-SDU- 2009-1

Identifier Type: -

Identifier Source: org_study_id