- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678832
Momentum Project Heidelberg - Dealing Actively With a Cancerous Disease
Social Cognitions and Norms Towards Physical Exercise Among Cancer Patients and Health Care Professionals
Study Overview
Status
Detailed Description
For this purpose, four large surveys with health care professionals (specialized practitioners, N=300; general practitioners, N=300; oncology nurses, N=300) and cancer patients (N=1200, 400 patients each with breast, prostate or colorectal cancer) with a cross-sectional research design are conducted.
Additionally, a follow-up-study with a sub-sample of cancer patients (N=180) will be conducted.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Cross-sectional surveys:
- 300 specialized practitioners who treat patients with breast, prostate or colorectal cancer (gynecologists, radiologists, urologists, gastroenterologists, oncologists, surgeons)
- 300 general practitioners
- 50 rehabilitation physicians
- 300 oncology nurses
- 1200 cancer patients with breast, prostate or colorectal cancer before or during cancer therapy (pre-treatment and primary cancer treatment time period according to PA and Cancer Control (PACC) framework)
- Longitudinal follow-up study: 180 patients [sub-sample of (5)] who are recruited before the initiation or at the beginning of their primary cancer treatment
Description
Inclusion Criteria:
- HCP are eligible if they meet the following inclusion criteria: Working as an oncological nurse, general practitioner or physician specialized in oncology, radiology, surgery, gynecology, urology, gastroenterology or rehabilitation Signed informed consent
- Patients are eligible if they meet the following inclusion criteria: Patients with a diagnosis of primary tumor or recurrence no longer than 2 years ago who are undergoing chemo- or radiotherapy currently or in the last 2 years Patients undergoing chemo- or radiotherapy currently or no longer than 2 years ago At least 18 years of age Sufficient German language skills Signed informed consent
Exclusion Criteria:
- HCP will be excluded from the trial if they meet the following exclusion criteria: No regular contact with cancer patients
- Patients will be excluded from the trial if they meet the following exclusion criteria: Presence of comorbidities that preclude involvement in exercise programs (e.g. severe pain, advanced heart failure [≥ NYHA III]) Mentally retarded Reduced standing ability and no ability to walk
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cancer patients
breast cancer prostate cancer colorectal cancer
|
|
Physicians
working in in- and outpatient care
|
|
Oncology nurses
working in in- and outpatient care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social norms and cognitions toward self-management strategies of cancer patients as assessed by the variables of the theory of planned behavior (TPB)
Time Frame: one-time self-report of current cognitions
|
Questionnaire items were developed in a pilot study according to the guidelines for a TPB questionnaire described by Ajzen (2006)
|
one-time self-report of current cognitions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity as assessed with SQUASH
Time Frame: one-time retrospective self-report about the past month
|
self-reported physical activity
|
one-time retrospective self-report about the past month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Monika Sieverding, Prof. Dr., Heidelberg University
- Principal Investigator: Karen Steindorf, Prof. Dr., German Cancer Research Center (DKFZ) & National Center for Tumor Diseases (NCT), Heidelberg
- Principal Investigator: Joachim Wiskemann, Dr., University of Heidelberg Medical Center & National Center for Tumor Diseases (NCT), Heidelberg
Publications and helpful links
General Publications
- Haussmann A, Ungar N, Tsiouris A, Schmidt L, Wiskemann J, Steindorf K, Sieverding M. Better not resting: Carving out attitudes and their associations with physical activity in people with cancer. Eur J Cancer Care (Engl). 2022 Sep;31(5):e13622. doi: 10.1111/ecc.13622. Epub 2022 May 22.
- Depenbusch J, Wiskemann J, Haussmann A, Tsiouris A, Schmidt L, Ungar N, Sieverding M, Steindorf K. Impact and Determinants of Structural Barriers on Physical Activity in People with Cancer. Int J Behav Med. 2022 Jun;29(3):308-320. doi: 10.1007/s12529-021-10014-0. Epub 2021 Sep 22.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110512/111223
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