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Prostate CarcinomaNCT02869412

Computer-Based Behavior Change Guide in Increasing Physical Activity in Patients With Prostate Cancer Who Have Received Androgen Deprivation Therapy

A study testing Computer-Assisted Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site 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 randomized pilot clinical trial studies how well a computer-based behavior change guide works in increasing physical activity in patients with prostate cancer who have received androgen deprivation therapy. Read more about this study

Who is it for?
Ages 21 years and older, men only
Conditions the study is for
Prostate Carcinoma
What is being tested?
Computer-Assisted Intervention, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Jan 2015to 31 Jul 2017
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prostate cancer (PCa) diagnosis
  • Able to read English on a computer screen
  • Signed an Institutional Review Board (IRB)-approved informed consent
  • EVALUATION PHASE
  • Underactive (defined as physically active for less than 30 minutes per day fewer than 2 days per week)
  • Access to a computer at home or public location

Who cannot join

  • Non-English speaking subjects are excluded from this study; the website being developed will only be available in English

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Physical Activity Behavior Change Guide for Prostate Cancer Patients (iTRAIN Study)

This randomized pilot clinical trial studies how well a computer-based behavior change guide works in increasing physical activity in patients with prostate cancer who have received androgen deprivation therapy. A computer-based behavior change guide website may increase physical activity level for prostate cancer survivors and help doctors understand what outcomes related to becoming physically active are most important to patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Engage with prostate cancer patients (PCPs) who have received or are currently on androgen deprivation therapy (ADT) to develop a computer-based behavior change guide (BCG) for PCPs to provide fundamental information about benefits of exercise for their individual capabilities and goals and provide a personalized physical activity plan. (Development Phase) II. Engage with PCPs to understand what outcomes are most important to them related to becoming active (e.g., helped me manage side-effects of treatment, reduced fatigue) and develop measures to evaluate these patient-centered outcomes. (Development Phase) III. Evaluate the BCG in a study comparing the personalized computer-based BCG with physical activity recommendations provided via a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors) among PCPs who have received ADT. (Evaluation Phase)

OUTLINE:

DEVELOPMENT PHASE: Patients view mock-ups of the BCG web design on a computer, iPad, or printed color paper and provide feedback with a one-on-one interview or separately using the think/talk aloud method followed by a one-on-one interview. After completion of these design rounds, patients use the BCG website and provide individual feedback.

EVALUATION PHASE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients use the BCG website which will collect personal information including individual health priorities/goals, demographics (i.e. age, ethnicity), health information (i.e. weight, height, cancer history, other health conditions), individual capabilities, physical activity level, and exercise preferences. Patients then receive a report with a personalized physical activity plan.

GROUP II: Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).

After completion of study, patients are followed up at 2 months.

Being tested
Computer-Assisted Intervention, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Computer-Assisted InterventionOther

    Use BCG website

  • Computer-Assisted InterventionOther

    Use passive website

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02869412
Study groupRoleWhat they receive
Group I (BCG website)ExperimentalPatients use the BCG website which will collect personal information including individual health priorities/goals, demographics (i.e. age, ethnicity), health information (i.e. weight, height, cancer history, other health conditions), individual capabilities, physical activity level, and exercise preferences. Patients then receive a report with a personalized physical activity plan.
Receives: Other: Computer-Assisted Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (passive website)Active comparatorPatients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).
Receives: Other: Computer-Assisted Intervention; 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.

  1. Change in self efficacy for exercise, assessed by the Self Efficacy for Exercise questionnaire (Evaluation Phase)

    For the qualitative characteristics collected, univariate summaries (e.g., frequency counts and proportions) will be calculated. For quantitative characteristics, means, standard deviations, medians, and ranges will be computed. The analysis will be conducted as an intent-to-treat efficacy assessment comparing the two interventions. Analyses will examine changes between baseline and follow-up scores on outcome measures by group. Comparisons will be conducted using Generalized Estimating Equations (GEE) with robust (sandwich) variance estimates.

    Measured: Baseline up to 2 months

  2. Stage of change for exercise, assessed by the Stage of Change for Exercise questionnaire (Evaluation Phase)

    For the qualitative characteristics collected, univariate summaries (e.g., frequency counts and proportions) will be calculated. For quantitative characteristics, means, standard deviations, medians, and ranges will be computed. The analysis will be conducted as an intent-to-treat efficacy assessment comparing the two interventions. Analyses will examine changes between baseline and follow-up scores on outcome measures by group. Comparisons will be conducted using GEE with robust (sandwich) variance estimates.

    Measured: Up to 2 months

  3. Website usability, assessed by qualitative evaluation of interviews and feedback (Development Phase)

    Measured: Up to 9 months

Secondary outcomes (7)

  1. Average activity level for seniors per Community Healthy Activity Model Program for Seniors (CHAMPS) questionnaire

    CHAMPS is a 41-item questionnaire developed by UCSF that asks about recent participation in specific physical activities and structured exercise to measure changes in physical activity level in older adults (age 65 and up). This questionnaire estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults. This physical activity survey has been used and validated with cancer survivors. The 41-item questionnaire asks about engagement in vigorous, moderate, and light activities per week, including frequency and duration, du

    Measured: Baseline up to 2 months

  2. Body weight

    Participants will be asked to self-report their current weight in pounds.

    Measured: Baseline up to 2 months

  3. Measurement of exercise motivation using the Behavioral Regulation In Exercise Questionnaire (BREQ)

    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 questions and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation. The basic issue concerns the degree to which one feels autonomous with respect to exercising or engaging in physical activity. The BREQ measures the continuum of behavioral regulation in exercise psychology research. The original BREQ (Mullan, Markland \& Ingledew, 1997) was developed to me

    Measured: Baseline up to 2 months

  4. Measurement of fatigue using the Piper Fatigue Scale

    The Piper Fatigue Scale measures fatigue in cancer research, and includes subdomains of behavioral, affective, sensory, and cognitive/mood attributes of fatigue. The Piper Fatigue Scale-12 is an instrument to measure the subjective dimension of fatigue, developed by BF Piper, AM Lindsey, MJ Dodd, S Ferketich, SM Paul and S Weller. The Piper Fatigue Scale is one of the commonly used multidimensional fatigue measures in the cancer research field and includes subdomains of behavioral, affective, sensory, and cognitive/mood attributes of fatigue.

    Measured: Baseline up to 2 months

  5. Measurement of quality of life per European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire-core 30 (QLQ-C30) questionnaire

    EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The QLQ-C30 incorporates 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 fu

    Measured: Baseline up to 2 months

  6. Self-reported physical activity assessed by the Rapid Assessment of Physical Activity (RAPA)

    The RAPA questionnaire was designed to provide clinicians with a tool for quickly assessing the level of physical activity of their older adult patients. It was developed after a review and evaluation of existing written questionnaires. The RAPA questionnaire was developed by University of Washington Health Promotion Research Center to provide clinicians with a tool for quickly assessing the level of physical activity of their older adult patients.

    Measured: Baseline up to 2 months

  7. Website use and acceptability assessed by questionnaire

    Questions about participant use and their perception of the website's features and usability will provide insights into the acceptability to revise it for further development. This is a study specific questionnaire developed to measure the frequency of use of the websites and participant preferences about exercise. Higher scores indicate better use and acceptance of the exercise information and website. In addition, the questionnaire includes an open ended question for participants to provide the study team with any additional thoughts or comments about the website.

    Measured: Responses collected at 2 months

Timeline

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

  1. First posted17 Aug 2016 (estimated)
  2. Study startJan 2015
  3. Primary completion31 Jul 2017
  4. Study completion31 Jul 2017

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02869412
Sponsor's protocol ID
IRB00011113
Other IDs
NCI-2016-01217, CPC-14128-L, 11113, IRB00011113, P30CA069533
Status last verified
Oct 2017
First submitted
9 Aug 2016
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Computer-Assisted Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Prostate Carcinoma, run by OHSU Knight 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 6 inclusion and 1 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 19 Oct 2017. 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 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?

Change in self efficacy for exercise, assessed by the Self Efficacy for Exercise questionnaire (Evaluation Phase) (time frame: Baseline up to 2 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 NCT02869412.

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 19 Oct 2017.

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