- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02566408
Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity
Attitudes, Beliefs and Preferences of Older Breast Cancer Survivors Towards Physical Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess physical activity beliefs, attitudes and preferences (KAPs) of breast cancer (BCa) survivors to inform the development of a physical activity (PA) intervention that will foster initial enrollment and sustained participation, particularly for African American (AA) and socioeconomic status (SES)-disadvantaged BCa survivors.
OUTLINE:
INTERVIEWS AND GROUP DISCUSSION: Participants undergo a 2-hour one-on-one interview about their KAPs towards PA. Ten topics will be used to explore older women's attitudes toward PA: (a) terminology used to describe PA; (b) meaning of PA to older women; (c) usual PA during daily life; (d) perceived influences and benefits of PA on body and mind; (e) recent changes in PA and their influences on women's daily life; (f) facilitators and barriers to older women's participation in PA; (g) preferences for PA in general and specific types of PA; (h) age-related differences in attitudes toward PA; (i) ethnic differences in attitudes toward PA; (i) SES-related differences in attitudes toward PA; and (j) overall feeling about PA. Six topics will also be used to explore ethnic-specific and culture-specific contexts that surround older women's participation in PA: (a) older women's daily life schedules, and hardships and sufferings in daily lives; (b) culturally unique aspects of women's daily lives; (c) age-related difficulties and advantages in daily lives influencing older women's participation in PA; (d) ethnicity-related, cultural-related and SES-related difficulties and advantages in daily lives influencing women's participation in PA; (f) culturally available support for PA and women's preferences for support; and (g) older women's preferences for PA promotion programs.
REFINEMENT OF THE PA INTERVENTION: Approximately 1-2 months after the conclusion of interviews, participants are invited to a joint session and presented with results of analyzed data. Participants are asked to review results and themes identified from interviews, and to concur whether conclusions capture their KAPs. Through this process a set of preferences that is agreed upon by all as most critical for enhancing PA participation, adherence, and retention will be identified.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically confirmed breast cancer
- Stage I-III
- Patients who have completed treatment for breast cancer and are within two years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapies in the adjuvant setting are allowed
- African-Americans and non-Hispanic Whites
Exclusion Criteria:
- Stage IV breast cancer
- Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
- Inability to understand English
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Care (interview about KAPs towards PA)
Participants undergo a 2-hour one-on-one interview and answer survey questions about their beliefs, attitudes, and preferences (KAPs) towards physical activity (PA). Ten topics will be used to explore older women's attitudes toward PA. Six topics will also be used to explore ethnic-specific and culture-specific contexts that surround older women's participation in PA. REFINEMENT OF THE PA INTERVENTION: Approximately 1-2 months after the conclusion of interviews, participants are invited to a joint session and presented with results of analyzed data. Participants are asked to review results and themes identified from interviews, and to concur whether conclusions capture their KAPs. Through this process a set of preferences that is agreed upon by all as most critical for enhancing PA participation, adherence, and retention will be identified. |
Undergo one-on-one interview about KAPs towards PA
Complete survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative analysis of in-depth interviews to identify features which foster initial enrollment of African Americans and Socioeconomic Status disadvantaged breast cancer survivors in breast cancer studies
Time Frame: 6 months
|
Features of the physical activity program that are important to the initial enrollment of older breast cancer survivors, particularly African American and Socioeconomic Status disadvantaged breast cancer survivors.
These features will be analyzed using descriptive statistics.
Examining the data by groups will further refine understanding of the emergent themes.
Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
|
6 months
|
Qualitative analysis of in-depth interviews to identify attitudes towards physical activity.
Time Frame: 6 months
|
Identification of attitudes of survivors toward physical activity will be analyzed using descriptive statistics.
Examining the data by groups will further refine understanding of the emergent themes.
Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
|
6 months
|
Qualitative analysis of in-depth interviews to identify attitudes towards the physical activity program.
Time Frame: 6 months
|
Identification of attitudes of survivors toward the physical activity program will be analyzed using descriptive statistics.
Examining the data by groups will further refine understanding of the emergent themes.
Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cynthia Owusu, Case Comprehensive Cancer Center
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE5115
- NCI-2015-01052 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CASE 5115 (Other Identifier: Case Comprehensive Cancer Center)
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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