- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06272513
Influencing Factors for Physical Activity in People With Head and Neck Cancer (ProAct-HNC)
Exploring Influencing Factors for Physical Activity Participation in People With Advanced Head and Neck Cancer - a Qualitative Study
The goal of this qualitative study is to explore influencing factors for physical activity (PA) participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.
Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:
- What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
- What motivates people with advanced head and neck cancer to be physically active?
- What are recommendations and suggestions for a future physical activity promotion intervention?
- How do significant others view capabilities, opportunities, and motivation for physical activity participation and promotion in people with head and neck cancer?
The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Canton of Zurich
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Winterthur, Canton of Zurich, Switzerland
- Kantonsspital Winterthur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
individual interview participants: 12 individuals with a diagnosis of a stage III or IV head and neck squamous cell carcinoma, after surgery & (chemo)radiotherapy
focus group interview participants: 8 significant others (partner, spouse, close familiy member or friend) of individuals with a diagnosis of a stage III or IV head and neck squamous cell carcinoma
Description
Inclusion criteria for people with head and neck cancer:
- minimal age 18
- diagnosis of a primary head and neck squamous cell carcinoma within the last 24 months
- oral, pharyngeal, or laryngeal cancer stage III or IV
- completed surgery and/or radio(chemo)therapy in curative intent
Exclusion criteria for people with head and neck cancer:
- not having the physical, mental, and cognitive ability to understand, follow and hold a conversation in (Swiss-)German
- treatment in palliative intent
- recurrence of the head and neck tumour (local or distant)
Inclusion criteria for significant others of people with head and neck cancer:
- minimal age 18
- being a significant other (partner, spouse, close family member or friend) of an individual with a head and neck cancer with the above-mentioned criteria
- having the permission of the individual affected by head and neck cancer to talk about their experiences
Exclusion criteria for significant others of people with head and neck cancer:
- not having the physical, mental, and cognitive ability to understand, follow and take part in a group discussion in (Swiss-)German
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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interview transcripts
Time Frame: March 2024- May 2025
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individual interviews and focus group interviews will be transcribed verbatim to be analyzed
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March 2024- May 2025
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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personal information of participants
Time Frame: March 2024- May 2025
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characteristics of interview and focus group participants will be collected to be able to describe the study participants, including age, education level, cancer stage, treatment received, activity levels
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March 2024- May 2025
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martina Schmocker, MSc, Cantonal Hospital Winterthur, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ProAct-HNC-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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European Organisation for Research and Treatment...Merck KGaA, Darmstadt, GermanySuspendedLocally Advanced Head and Neck Squamous Cell CarcinomaNetherlands, Belgium, Ireland, United Kingdom, France, Germany, Norway, Slovenia, Italy, Spain