Cancer SurvivorNCT04290962
Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors
A study testing Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer Survivor
- What is being tested?
- Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 14 Oct 2020
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has contacted study investigators using the contact information found on recruitment materials to convey their interest in participating
- Verbally confirmed that they now currently or in the past have functioned as a WRM for NWP
- Body mass index (BMI) >= 23
- Weight stable over the past year (=< 10% change)
- Current levels of physical activity were assessed and compared to United States (US) Centers for Disease Control and Prevention (CDC) Physical Activity (PA) guidelines (150 minutes of moderately intensive weekly physical activity)
- Cleared to participate in an exercise program via the American College of Sports Medicine Exercise Pre-participation Health Screening Guidelines
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- Has access to internet and a computer/tablet etc
- Has access to basic fitness equipment (dumbbells, resistance bands) and/or is willing to join a fitness facility
- Is currently under the care of and has been assessed by a primary care physician within the last 12 months
- Understands the investigational nature of this study and completes the process of informed consent per Institutional Review Board (IRB) approved protocol
Who cannot join
- Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Is pregnant or nursing
- Is unwilling or unable to participate
- Has any condition which in the investigators' opinion(s) deems the subject an unsuitable candidate to participate in this study
- Has metastatic cancer
- Has an orthopedic disorder, neuromuscular disorder or other condition (e.g., arthritis, morbid obesity) that may significantly preclude participation in exercise or related behaviors
- Is currently incarcerated (i.e., prisoner)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Participating in the web-based lifestyle intervention program reinforced with experienced lifestyle coaches and consisting of physical activity, nutritional/lifestyle habits, and educational lessons may help to improve overall health and well-being, fitness level, and quality of life in African American cancer survivors.
Read the detailed description
PRIMARY OBJECTIVE:
- To conduct a pilot implementation research study to determine the viability, safety, and effectiveness of the use of a 12-month, commercially available, web-based lifestyle behavioral medicine intervention program by individuals who are or have been a Witness Role Model (WRM) in the National Witness Project (NWP).
SECONDARY OBJECTIVE:
- To examine the feasibility of this research to subsequently investigate the effects of optimal health and/or lifestyle related behavioral medicine interventions used to promote optimal health on mitigating cancer-related and overall mortality disparities in African Americans (AA), and comorbidity/ chronic disease(s) management over time. (EXPLORATORY)
OUTLINE:
Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change.
- Conditions
- Cancer Survivor
- Being tested
- Lifestyle Therapy, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle TherapyBehavioural
Complete web-based lifestyle intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (web-based lifestyle intervention) | Experimental | Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change. Receives: Behavioral: Lifestyle Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrollment
Measured: Up to 12 months
Rate of refusal
Measured: Up to 12 months
Program adherence rate
Measured by participation and online tracking of activity completion (workout, habit, and lessons). An overall adherence score will be calculated by averaging the percentage of time each of the 3 activities were completed by each participant over the 12-month intervention.
Measured: Up to 12 months
Program retention
Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention.
Measured: Up to 12 months
Incidence of physical activity related injuries
Biweekly inquiries about possible injuries will be conducted.
Measured: Up to 12 months
Program effectiveness
The effects of the lifestyle intervention program will be ascertained via primarily subjective, self-reported assessments administered at pre-intervention, post-intervention, and a follow-up. Subjective data will be validated through the collection of objective data in a subset of local participants via in-person assessments. Generalized linear mixed model methods, specifically a repeated measures analysis of variance with a random participant effect, as well as fixed effects for time and interaction will be used.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start17 Jan 2019
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Why it stopped: no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Devonish, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290962
- Sponsor's protocol ID
- I 77418
- Other IDs
- NCI-2019-06115, I 77418
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
- ClinicalTrials.gov ID
- NCT04290962
- Acronym / sponsor ID
- I 77418
- Conditions
- Cancer Survivor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 2 Mar 2020 (actual)
- 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.
This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Participating in the web-based lifestyle intervention program reinforced with experienced lifestyle coaches and consisting of physical activity, nutritional/lifestyle habits, and educational lessons may help to improve overall health and well-being, fitness level, and quality of life in African American cancer survivors.
Detailed description
PRIMARY OBJECTIVE:
- To conduct a pilot implementation research study to determine the viability, safety, and effectiveness of the use of a 12-month, commercially available, web-based lifestyle behavioral medicine intervention program by individuals who are or have been a Witness Role Model (WRM) in the National Witness Project (NWP).
SECONDARY OBJECTIVE:
- To examine the feasibility of this research to subsequently investigate the effects of optimal health and/or lifestyle related behavioral medicine interventions used to promote optimal health on mitigating cancer-related and overall mortality disparities in African Americans (AA), and comorbidity/ chronic disease(s) management over time. (EXPLORATORY)
OUTLINE:
Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (web-based lifestyle intervention) | Experimental | Behavioral: Lifestyle Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has contacted study investigators using the contact information found on recruitment materials to convey their interest in participating
- Verbally confirmed that they now currently or in the past have functioned as a WRM for NWP
- Body mass index (BMI) >= 23
- Weight stable over the past year (=< 10% change)
- Current levels of physical activity were assessed and compared to United States (US) Centers for Disease Control and Prevention (CDC) Physical Activity (PA) guidelines (150 minutes of moderately intensive weekly physical activity)
Key exclusion criteria (7 listed)
- Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Is pregnant or nursing
- Is unwilling or unable to participate
- Has any condition which in the investigators' opinion(s) deems the subject an unsuitable candidate to participate in this study
- Has metastatic cancer
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 |
|---|---|---|
| Lifestyle TherapyComplete web-based lifestyle intervention | Behavioural | Supportive Care (web-based lifestyle intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (web-based lifestyle intervention) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (web-based lifestyle intervention) |
Primary outcome
Rate of enrollment
Time frame: Up to 12 months
Rate of refusal
Time frame: Up to 12 months
Program adherence rate
Time frame: Up to 12 months
Measured by participation and online tracking of activity completion (workout, habit, and lessons). An overall adherence score will be calculated by averaging the percentage of time each of the 3 activities were completed by each participant over the 12-month intervention.
Program retention
Time frame: Up to 12 months
Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention.
Incidence of physical activity related injuries
Time frame: Up to 12 months
Biweekly inquiries about possible injuries will be conducted.
Program effectiveness
Time frame: Up to 12 months
The effects of the lifestyle intervention program will be ascertained via primarily subjective, self-reported assessments administered at pre-intervention, post-intervention, and a follow-up. Subjective data will be validated through the collection of objective data in a subset of local participants via in-person assessments. Generalized linear mixed model methods, specifically a repeated measures analysis of variance with a random participant effect, as well as fixed effects for time and interaction will be used.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Julia Devonish principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Cancer Survivor, run by Roswell Park Cancer Institute at 1 site in United States.
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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Apr 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of enrollment (time frame: Up to 12 months). The study lists 6 primary outcomes in all. 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 27 Apr 2023.