Case Management in Oncology Rehabilitation
| ISRCTN | ISRCTN41474586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41474586 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Institut für Hausarztmedizin
Universitätsspital
Sonneggstrasse 6
Zurich
8091
Switzerland
| irene.bachmann@usz.ch |
Study information
| Study design | Multicentre parallel-group randomised two-arm intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/06/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
8091
Switzerland
Sponsor information
Swiss Cancer League (Krebsliga Schweiz) (Switzerland)
Charity
Charity
Effingerstrasse 40
Bern
3001
Switzerland
| irene.bachmann@usz.ch | |
| Website | http://www.krebsliga.ch/de/index.cfm |
"ROR" |
https://ror.org/01pd7my79 |
Funders
Funder type
Charity
Krebsliga Schweiz
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Lega Svizzera Contro il Cancro, Swiss Cancer League, Ligue Suisse Contre le Cancer
- Location
- Switzerland
Universität Zürich
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Zurich, Switzerland, University of Zurich, UZH
- Location
- Switzerland
University Hospital Zurich (Universitätsspital Zürich) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/04/2011 | Yes | No | |
| Results article | results | 28/03/2017 | Yes | No |
Editorial Notes
30/03/2017: Publication reference added.
