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Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602041
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
J. Nuver, University Medical Center Groningen

Tracking Information
First Submitted Date November 3, 2015
First Posted Date November 11, 2015
Last Update Posted Date November 14, 2017
Actual Study Start Date November 2015
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2015)
Gain insight into barriers and facilitators for health behavior change [ Time Frame: 12 months ]
Qualitative description of barriers and facilitators for health behavior change
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Official Title Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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).
Condition
  • Breast Cancer
  • Testicular Cancer
Intervention Other: Literature search and semi-structured interview
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 Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: Literature search and semi-structured interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2017)
38
Original Estimated Enrollment
 (submitted: November 7, 2015)
40
Actual Study Completion Date July 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • signs or symptoms of recurrent disease
  • mental disability
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02602041
Other Study ID Numbers 201501074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party J. Nuver, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: J. Nuver, MD, PHD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date November 2017