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

Primary Purpose

Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Informational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Telephone-Based Intervention
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stage I Prostate Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Harris Health System (LBJ)
  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (exercise, nutrition counseling)

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment and retention
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.
Intervention adherence
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

Surveillance lifestyle
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.
Elements of the intervention that were successful and/or need improvements
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.

Full Information

First Posted
June 20, 2018
Last Updated
April 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03575832
Brief Title
Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners
Official Title
Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (exercise, nutrition counseling)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Complete nutrition counseling sessions
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive an exercise plan and printed materials
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone coaching calls
Primary Outcome Measure Information:
Title
Recruitment and retention
Description
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.
Time Frame
Up to 8 months
Title
Intervention adherence
Description
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.
Time Frame
Up to 8 months
Secondary Outcome Measure Information:
Title
Surveillance lifestyle
Description
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.
Time Frame
Up to 8 months
Title
Elements of the intervention that were successful and/or need improvements
Description
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.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorna McNeill
Phone
713-563-1103
Email
lmcneill@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harris Health System (LBJ)
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilary Ma
Phone
713-792-4171
First Name & Middle Initial & Last Name & Degree
Hilary Ma
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorna McNeill
Phone
713-563-1103
Email
lmcneill@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lorna McNeill

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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

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