Case Management in Oncology Rehabilitation

ISRCTN	ISRCTN41474586
DOI	https://doi.org/10.1186/ISRCTN41474586
Protocol serial number	N/A
Sponsor	Swiss Cancer League (Krebsliga Schweiz) (Switzerland)
Funders	Krebsliga Schweiz, Universität Zürich, University Hospital Zurich (Universitätsspital Zürich) (Switzerland)

Submission date: 11/10/2010
Registration date: 24/11/2010
Last edited: 30/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Irene Bachmann
Scientific

Institut für Hausarztmedizin
Universitätsspital
Sonneggstrasse 6
Zurich
8091
Switzerland

Email	irene.bachmann@usz.ch

Study information

Primary study design	Interventional
Study design	Multicentre parallel-group randomised two-arm intervention trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	CAMON
Study objectives	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(s)	Ethics Board of the Kanton Zurich (Switzerland), 20/05/2010, ref: KEK-ZH-NR-2009 - 0145/1
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Quality of life: Fact G, (FACIT), measured at month 0, 3, 6 and 12
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	132
Key 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
Key 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
Date of first enrolment	01/06/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

Institut für Hausarztmedizin

Zurich
8091
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/03/2017		Yes	No
Protocol article	protocol	28/04/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/03/2017: Publication reference added.