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

NCT02869412 | Completed DMC

• 5 other identifiers: IRB00011113NCI-2016-01217CPC-14128-L11113P30CA069533
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline up to 2 months

• 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.

  Up to 2 months

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

  Up to 9 months

Secondary Outcomes (7)

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

  Baseline up to 2 months

• Body weight

  Baseline up to 2 months

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

  Baseline up to 2 months

• Measurement of fatigue using the Piper Fatigue Scale

  Baseline up to 2 months

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

  Baseline up to 2 months

Study Arms (2)

Group I (BCG website)

EXPERIMENTAL

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.

Other: Computer-Assisted Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (passive website)

ACTIVE COMPARATOR

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

Other: Computer-Assisted Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Computer-Assisted Intervention OTHER

Use BCG website

Group I (BCG website)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (BCG website); Group II (passive website)

Questionnaire Administration OTHER

Ancillary studies

Group I (BCG website); Group II (passive website)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Esther Moe

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 17, 2016
• Study Start: January 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)