Condition category
Cancer
Date applied
11/10/2010
Date assigned
24/11/2010
Last edited
21/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hausarztmedizin.uzh.ch

Contact information

Type

Scientific

Primary contact

Mrs Irene Bachmann

ORCID ID

Contact details

Institut für Hausarztmedizin
Universitätsspital
Sonneggstrasse 6
Zurich
8091
Switzerland
irene.bachmann@usz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation - a randomised, controlled, parallel-group clinical trial

Acronym

CAMON

Study hypothesis

The implementation of several elements of the Chronic Care Model (CCM) via a case manager in the rehabilitation (trained registered oncology nurse) has a positive effect of the quality of life of cancer patients one year after an adjuvant therapy.

Ethics approval

Ethics Board of the Kanton Zurich (Switzerland) approved on the 20th May 2010 (ref: KEK-ZH-NR-2009 - 0145/1)

Study design

Multicentre parallel-group randomised two-arm intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer - neoplasm

Intervention

Apart from the usual medical provision, i.e., consultations with the general practitioner and oncologist, and the therapies and measures prescribed as part of rehabilitation - randomised patients in the intervention group will be allocated an additional contact person (case manager) for the duration of one year after completion of adjuvant therapy. The contact person will be concerned with non-medical issues, information brokerage, encouragement of self-management and self-efficacy, as well as individually planning the rehabilitation program, and giving support with coordination management. The task is carried out by an experienced oncology nurse with additional training.

Patients who have been randomised in the control group will receive the usual medical provision.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quality of life: Fact G, (FACIT), measured at month 0, 3, 6 and 12

Secondary outcome measures

1. Ability to work: recorded by means of sick leave questionnaire
2. Self-efficacy: Questionnaire self-efficacy expectation
3. Health care utilisation (general practitioner/oncologist, specialists and hospitalisation), illustrated as number of contacts: Questionnaire
4. Unplanned consultations (general practitioner/oncologist, specialists and hospitalisation), illustrated as number of contacts that were unplanned: Questionnaire
5. Satisfaction with medical care: PACIC Questionnaire

Overall trial start date

01/06/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or greater, either sex
2. Completion of a therapy with chemo- and/or radiotherapy/surgery (longer term hormone and antibody therapy are excluded)
3. Therapy with curative intention or longer term estimated survival time
4. Increased distress score (score 2 - 7)
5. Intention to undertake ambulant rehabilitation
6. Rehabilitation need/prevailing strain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

132

Participant exclusion criteria

1. Patients with metastasis and/or cancer at an advanced stage with palliative therapy
2. Patients with an estimated survival time of less than one year
3. Patients with insufficient knowledge of the German language to take part in counselling and evaluations
4. Patients with severe psychiatric diagnoses or apparent great distress requiring medical psychiatric treatment
5. Completion of therapy longer than one month ago

Recruitment start date

01/06/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institut für Hausarztmedizin
Zurich
8091
Switzerland

Sponsor information

Organisation

Swiss Cancer League (Krebsliga Schweiz) (Switzerland)

Sponsor details

Effingerstrasse 40
Bern
3001
Switzerland
irene.bachmann@usz.ch

Sponsor type

Charity

Website

http://www.krebsliga.ch/de/index.cfm

Funders

Funder type

Charity

Funder name

Swiss Cancer League (Krebsliga Schweiz) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Zurich (Universität Zürich) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital Zurich (Universitätsspital Zürich) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21526985

Publication citations

  1. Protocol

    Bachmann-Mettler I, Steurer-Stey C, Senn O, Wang M, Bardheci K, Rosemann T, Case management in oncology rehabilitation (CAMON): the effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. a study protocol for a randomized controlled clinical trial in oncology rehabilitation., Trials, 2011, 12, 103, doi: 10.1186/1745-6215-12-103.

Additional files

Editorial Notes