Breast CancerNCT02602041
Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
An observational study of Breast Cancer and Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Testicular Cancer
- What is being tested?
- Literature search and semi-structured interview
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to 1 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will invite 10 women with early stage breast cancer (BC) and 10 men with disseminated testicular cancer (TC) and their partners (20 couples in total).
Who may be able to join
- between 18 and 65 years of age
- have completed adjuvant or curative chemotherapy (in BC and TC patients, respectively) or started adjuvant hormonal therapy alone (in BC patients) between 6 and 24 months previously
- have no signs or symptoms of recurrent disease
- be in follow-up at the Department of Medical Oncology of the UMCG.
Who cannot join
- signs or symptoms of recurrent disease
- mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners
The investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their partners. It will also direct future interventions to adequately target patients and, potentially, their partners to improve their lifestyle following a cancer diagnosis.
Read the detailed description
The investigators will perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.
- Conditions
- Breast Cancer, Testicular Cancer
- Being tested
- Literature search and semi-structured interview
- Medical subject headings
- Breast Neoplasms, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Literature search and semi-structured interviewOther
We will do a literature search and perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer and partners | We will invite 10 women with early stage breast cancer (BC) and their partners for a semi-structured interview. Receives: Other: Literature search and semi-structured interview | |
| Patients with testicular cancer and partners | We will invite 10 men with disseminated testicular cancer (TC) and their partners for a semi-structured interview. Receives: Other: Literature search and semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain insight into barriers and facilitators for health behavior change
Qualitative description of barriers and facilitators for health behavior change
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Nuver, MD, PHD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602041
- Sponsor's protocol ID
- 201501074
- Status last verified
- May 2024
- First submitted
- 3 Nov 2015
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners
- ClinicalTrials.gov ID
- NCT02602041
- Acronym / sponsor ID
- 201501074
- Conditions
- Breast Cancer, Testicular Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 11 Nov 2015 (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 investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their partners. It will also direct future interventions to adequately target patients and, potentially, their partners to improve their lifestyle following a cancer diagnosis.
Detailed description
The investigators will perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer and partners | – | Other: Literature search and semi-structured interviewWe will invite 10 women with early stage breast cancer (BC) and their partners for a semi-structured interview. |
| Patients with testicular cancer and partners | – | Other: Literature search and semi-structured interviewWe will invite 10 men with disseminated testicular cancer (TC) and their partners for a semi-structured interview. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will invite 10 women with early stage breast cancer (BC) and 10 men with disseminated testicular cancer (TC) and their partners (20 couples in total).
Key inclusion criteria (4 listed)
- between 18 and 65 years of age
- have completed adjuvant or curative chemotherapy (in BC and TC patients, respectively) or started adjuvant hormonal therapy alone (in BC patients) between 6 and 24 months previously
- have no signs or symptoms of recurrent disease
- be in follow-up at the Department of Medical Oncology of the UMCG.
Key exclusion criteria (2 listed)
- signs or symptoms of recurrent disease
- mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Literature search and semi-structured interviewWe will do a literature search and perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment. | Other | Patients with breast cancer and partners, Patients with testicular cancer and partners |
Primary outcome
Gain insight into barriers and facilitators for health behavior change
Time frame: 12 months
Qualitative description of barriers and facilitators for health behavior change
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 6 May 2024.
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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.
J. Nuver, MD, PHD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Gain insight into barriers and facilitators for health behavior change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.