This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575832
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : November 8, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This pilot trial studies how well Watchful Living works in improving quality of life in participants with prostate cancer that has not spread to other parts of the body who are on active surveillance and their partners. A social support lifestyle intervention (called Watchful Living) may help African American prostate cancer participants and their partners improve their quality of life, physical activity, diet, and inflammation.

Condition or disease Intervention/treatment Phase
Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Other: Counseling Other: Informational Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.

SECONDARY OBJECTIVES:

I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).

II. To conduct a process evaluation of the lifestyle intervention. III. Explore participants' satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.

OUTLINE:

Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Supportive care (exercise, nutrition counseling)
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
 Other: Counseling
Complete nutrition counseling sessions
Other Name: Counseling Intervention

Other: Informational Intervention
Receive an exercise plan and printed materials

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive telephone coaching calls


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recruitment and retention [ Time Frame: Up to 8 months ]
    Rates of study eligibility, recruitment, and retention will be assessed. Will maintain detailed information during the recruitment process regarding numbers of patients and their partners interested, eligible, ineligible (and reasons for ineligibility), and enrolled (and reasons for choosing not to enroll if deemed eligible). Will calculate rates of study eligibility, recruitment, and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs), along with graphical display (e.g., box plots). Will also assess reasons for withdrawal from study among those that chose to withdraw. Will examine the differences between dropout and non-dropout group at each time point by demographic factors such as age, gender, marital status, education, and income.

  2. Intervention adherence [ Time Frame: Up to 8 months ]
    The intervention adherence rate for each dyad is defined as the proportion of intervention sessions completed by both the patient and partner. Will also look at percentage of both patient and partner completing a minimum of 7 out of 10 coaching calls and both nutrition counseling sessions.


Secondary Outcome Measures :
  1. Surveillance lifestyle [ Time Frame: Up to 8 months ]
    Will report means, standard deviations, and distributions of survey measures (including pre-post changes of these measures, as appropriate) for ceiling/floor effects and restrictions in range. Outcome measures will be treated as continuous variables. Linear mixed models will be used when combined data from both patients and partners are analyzed due to their correlation within couples. Two-sided statistical tests will be performed, and the significance level for each test will be set at 0.05 without adjustment for multiple testing. All results from the statistical tests will be interpreted as hypothesis generating rather than conclusive findings. Will also perform paired t-tests to compare efficacy outcomes of interest between baseline and post intervention separately for patients and partners.

  2. Elements of the intervention that were successful and/or need improvements [ Time Frame: Up to 8 months ]
    Will conduct focus groups with a subsample of patient-partner dyads. Questions will address participants' experiences; thoughts about strengths, weaknesses, and needed improvements; perceptions about outcomes and impact; and overall reactions to and satisfaction with the intervention.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identify as black or African American or Hispanic (patient)
  • Be greater than 18 years of age (patient and spouse or intimate partner)
  • Have 0-III stage prostate cancer (patient)
  • If treated, have completed therapy (e.g., surgery, chemo and/or radiation) (patient)
  • Enroll with a spouse or intimate partner (patient)
  • Do not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week) (patient and spouse or intimate partner)
  • Be ready and able to be physically active, as determined by a physician (letter from a physician or nurse practitioner) (patient and spouse or intimate partner)
  • Not participate in another physical activity, diet, or lifestyle program (patient)
  • Have a valid home address and telephone number (patient)
  • Internet access at home or other location (e.g., work, church, library, community center, etc.) (spouse or intimate partner)
  • Patients on active surveillance will be included

Exclusion Criteria:

  • They have an active noncutaneous malignancy at any site (patient)
  • Had prior radiation therapy for treatment of the primary tumor (patient)
  • Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period (patient)
  • Are enrolled in another active surveillance protocol (patient)
  • Participated in formative focus groups for this study (patient and spouse or intimate partner)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575832


Contacts
Layout table for location contacts
Contact: Lorna McNeill 713-563-1103 lmcneill@mdanderson.org

Locations
Layout table for location information
United States, Texas
Harris Health System (LBJ) Not yet recruiting
Houston, Texas, United States, 77026
Contact: Hilary Ma    713-792-4171      
Principal Investigator: Hilary Ma         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorna McNeill    713-563-1103    lmcneill@mdanderson.org   
Principal Investigator: Lorna McNeill         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Lorna McNeill M.D. Anderson Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03575832    
Other Study ID Numbers: 2017-0556
NCI-2018-01406 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0556 ( Other Identifier: M D Anderson Cancer Center )
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: November 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases