Clinical trial NCT02678832: Momentum Project Heidelberg - Dealing Actively With a Cancerous Disease
Official title: Social Cognitions and Norms Towards Physical Exercise Among Cancer Patients and Health Care Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Breast Cancer
Prostate Cancer
Physicians
Nurses
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: University of Heidelberg Medical Center
name: National Center for Tumor Diseases, Heidelberg
name: German Cancer Aid
First posted: 2016-02-10
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-sectional surveys:

1. 300 specialized practitioners who treat patients with breast, prostate or colorectal cancer (gynecologists, radiologists, urologists, gastroenterologists, oncologists, surgeons)
2. 300 general practitioners
3. 50 rehabilitation physicians
4. 300 oncology nurses
5. 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)
6. 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

Brief summary: The study, investigates the current physical activity promotion practices among physicians and nurses, as well as social norms toward physical activity during treatment among cancer patients and among physicians and nurses who treat or counsel cancer patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social norms and cognitions toward self-management strategies of cancer patients as assessed by the variables of the theory of planned behavior (TPB)
timeFrame: one-time self-report of current cognitions
Secondary outcomes:
measure: Physical activity as assessed with SQUASH
timeFrame: one-time retrospective self-report about the past month
Other outcomes:
Locations:
Study officials:
affiliation: Heidelberg University
name: Monika Sieverding, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Center (DKFZ) & National Center for Tumor Diseases (NCT), Heidelberg
name: Karen Steindorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Heidelberg Medical Center & National Center for Tumor Diseases (NCT), Heidelberg
name: Joachim Wiskemann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.