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Cancer SurvivorNCT03406013

Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

A study testing Written Information, Prescription and Technology in people with Cancer Survivor and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer Survivor, Prostate Carcinoma
What is being tested?
Written Information, Prescription and Technology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
2 sitesUnited States
Study dates
1 Aug 2017to 31 Mar 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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-reported prostate cancer diagnosis
  • Able to read English on a computer screen
  • Able to access a computer, tablet or smartphone at home or public location
  • Access to a device capable of receiving plain text messages
  • A personal email address

Who cannot join

  • Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria and who do not receive a physician clearance to participate in the moderate intensity physical activity with one or more of the following self-reported conditions:
  • heart attack
  • heart surgery, cardiac catheterization, or coronary angioplasty
  • pacemaker/implantable cardiac defibrillator/rhythm disturbance
  • heart valve disease
  • heart failure
Show all 16Show fewer
  • heart transplantation
  • congenital heart disease
  • diabetes
  • kidney (renal) disease
  • chest discomfort with exertion
  • unreasonable breathlessness
  • dizziness, fainting or blackouts
  • ankle swelling
  • unpleasant awareness of forceful, rapid or irregular heart rate
  • burning or cramping sensations in your lower legs when walking short distance

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors

This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.

SECONDARY OBJECTIVES:

  1. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.

OUTLINE: Patients are assigned to 1 of 4 groups.

GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.

GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.

GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.

GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.

After completion of intervention, patients are followed up at 3 months.

Being tested
Written Information, Prescription, Technology, Coaching
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written InformationBehavioural

    Receive written information on diet and exercise relevant to older men with prostate cancer

  • PrescriptionBehavioural

    Participants receive tailored exercise prescription and tailored diet recommendations

  • TechnologyBehavioural

    Participants receive motivational text messages and can electronically log and track their exercise and diet habits

  • CoachingBehavioural

    Participants receive access to an exercise and diet coach to provide advice by phone and/or email

Study groups in NCT03406013
Study groupRoleWhat they receive
Group IActive comparatorWritten Information
Receives: Behavioral: Written Information
Group IIExperimentalWritten Information Prescription
Receives: Behavioral: Written Information; Behavioral: Prescription
Group IIIExperimentalWritten Information Prescription Technology
Receives: Behavioral: Written Information; Behavioral: Prescription; Behavioral: Technology
Group IVExperimentalWritten Information Prescription Technology Coaching
Receives: Behavioral: Written Information; Behavioral: Prescription; Behavioral: Technology; Behavioral: Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual success

    Measured as ability to recruit target sample size within one year

    Measured: Up to 3 months

  2. Retention

    Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled

    Measured: Up to 6 months

  3. Adherence to the study

    Measured as the # of times that a man visits the portal over three months

    Measured: Up to 3 months

Secondary outcomes (11)

  1. Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey

    CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.

    Measured: Baseline, 3 months, and 6 months

  2. Harvard T.H. Chan School of Public Health Food Frequency Questionnaire for adults from 2007

    This 132-item survey assesses dietary intake over the past month in categories from "never or less than once per month" to "6 or more times per day" and supports examining major food and nutrient categories of the U.S. diet.

    Measured: Baseline, 3 months, and 6 months

  3. Self-Efficacy for Exercise

    A 6-item measure of Self-efficacy for Exercise will be used. Summed scores range from 6-30, and higher scores indicate higher self-efficacy.

    Measured: Baseline, 3 months, and 6 months

  4. Physical Activity Stage Assessment

    This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.

    Measured: Baseline, 3 months, and 6 months

  5. Charlson Comorbidity Index

    The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.

    Measured: Baseline, 3 months, and 6 months

  6. Self-Efficacy for Diet

    Diet self-efficacy will be measured by having participants rate their confidence in performing each recommended task (e.g., two more servings of cooked tomatoes per week) using a Likert scale.

    Measured: Baseline, 3 months, and 6 months

  7. Pittsburgh Sleep Quality Index

    This self-report questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.

    Measured: Baseline, 3 months, and 6 months

  8. Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

    MAX-PC is an 18 item scale to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence.

    Measured: Baseline, 3 months, and 6 months

  9. PROMIS 7-item Short Form - Fatigue

    PROMIS - Fatigue evaluates self-reported symptoms of fatigue, from mild subjective feelings of tiredness to an overwhelming sense of exhaustion over the past seven days.

    Measured: Baseline, 3 months, and 6 months

  10. Behavioral Regulation in Exercise Questionnaire (BREQ2)

    BREQ2 measures the continuum of behavioral regulation in exercise psychology research. This questionnaire concerns the reasons why a person exercises regularly, works out, or engages in other such physical activities. It is structured so that it asks one question and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation.

    Measured: Baseline, 3 months, and 6 months

  11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients and has five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores range from 0-100, with higher functional scale scores indicating a higher level of healthy functioning while a higher score for a symptom scale represents a higher level of symptomatology or problems.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Aug 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Mar 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406013
Sponsor's protocol ID
STUDY00016703
Other IDs
NCI-2017-01048, STUDY00016703
Status last verified
Jul 2020
First submitted
22 Jul 2017
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chan JM, Van Blarigan EL, Langlais CS, Zhao S, Ramsdill JW, Daniel K, Macaire G, Wang E, Paich K, Kessler ER, Beer TM, Lyons KS, Broering JM, Carroll PR, Kenfield SA, Winters-Stone KM. Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. J Med Internet Res. 2020 Dec 31;22(12):e19238. doi: 10.2196/19238.

    PubMed 33382378

  • Winters-Stone KM, Kenfield SA, Van Blarigan EL, Moe EL, Ramsdill JW, Daniel K, Macaire G, Paich K, Kessler ER, Kucuk O, Gillespie TW, Lyons KS, Beer TM, Broering JM, Carroll PR, Chan JM. Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 15;7(11):e11257. doi: 10.2196/11257.

    PubMed 30442638

Questions about this trial

What is this clinical trial studying?

A study testing Written Information, Prescription and Technology in people with Cancer Survivor and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 2 sites 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Accrual success (time frame: Up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406013, which also lists 2 linked publications.

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 29 Jul 2020.

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