Colorectal CancerNCT02678832
Momentum Project Heidelberg - Dealing Actively With a Cancerous Disease
An observational study of Colorectal Cancer and Breast Cancer, run by Heidelberg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Prostate Cancer
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Social Cognitions and Norms Towards Physical Exercise Among Cancer Patients and Health Care Professionals
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.
Read the 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.
- Conditions
- Colorectal Cancer, Breast Cancer, Prostate Cancer, Physicians, Nurses
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Social norms and cognitions toward self-management strategies of cancer patients as assessed by the variables of the theory of planned behavior (TPB)
Questionnaire items were developed in a pilot study according to the guidelines for a TPB questionnaire described by Ajzen (2006)
Measured: one-time self-report of current cognitions
Secondary outcomes (1)
Physical activity as assessed with SQUASH
self-reported physical activity
Measured: one-time retrospective self-report about the past month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center, University of Heidelberg Medical Center, National Center for Tumor Diseases, Heidelberg, German Cancer Aid
- Responsible party
- Principal investigator, Nadine Ungar, Heidelberg University
- Investigators
- Monika Sieverding, Prof. Dr., Principal investigator, Heidelberg UniversityKaren Steindorf, Prof. Dr., Principal investigator, German Cancer Research Center (DKFZ) & National Center for Tumor Diseases (NCT), HeidelbergJoachim Wiskemann, Dr., Principal investigator, University of Heidelberg Medical Center & National Center for Tumor Diseases (NCT), Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678832
- Sponsor's protocol ID
- 110512/111223
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35599349Depenbusch 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.
PubMed 34550527
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognitions and Norms Towards Physical Exercise Among Cancer Patients and Health Care Professionals
- ClinicalTrials.gov ID
- NCT02678832
- Acronym / sponsor ID
- 110512/111223
- Conditions
- Colorectal Cancer, Breast Cancer, Prostate Cancer, Physicians, Nurses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Cancer Research Center, University of Heidelberg Medical Center, National Center for Tumor Diseases, Heidelberg, German Cancer Aid
- Study start
- Dec 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | –breast cancer prostate cancer colorectal cancer |
| Physicians | – | –working in in- and outpatient care |
| Oncology nurses | – | –working in in- and outpatient care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Physical activity as assessed with SQUASH
Time frame: one-time retrospective self-report about the past month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 35599349Haussmann 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.
- Derived from this study: PubMed 34550527Depenbusch 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.
- Homepage of the StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Sieverding, Prof. Dr. principal investigator
Heidelberg University
Karen Steindorf, Prof. Dr. principal investigator
German Cancer Research Center (DKFZ) & National Center for Tumor Diseases (NCT), Heidelberg
Joachim Wiskemann, Dr. principal investigator
University of Heidelberg Medical Center & National Center for Tumor Diseases (NCT), Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Breast Cancer, run by Heidelberg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.