NCT02224482

Brief Summary

The purpose of this study is to test how well an online program designed to help prostate cancer survivors cope with changes caused by their cancer or treatment works compared to standard print educational materials from the National Cancer Institute (NCI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

5.3 years

First QC Date

August 21, 2014

Results QC Date

February 27, 2020

Last Update Submit

October 11, 2021

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Adaptive Coping

    Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).

    Change in coping from baseline to six months

Secondary Outcomes (6)

  • Physical Functioning - Urinary Incontinence

    Change from baseline to six months

  • Physical Functioning - Urinary Irritation

    Change from baseline to six months

  • Physical Functioning - Bowel

    Change from baseline to six months

  • Physical Functioning - Sexual Functioning

    Change from baseline to six months

  • Interpersonal Concerns - Medical Interactions

    Change from baseline to six months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Print materials

Intervention Group

ACTIVE COMPARATOR

PROGRESS

Behavioral: PROGRESS

Interventions

PROGRESSBEHAVIORAL

PROGRESS is a multimedia website designed to help prostate cancer survivors.

Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Received a diagnosis of localized disease confined to the prostate, with no regional lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; T2c \[3\]);
  • Within one year completion of either radical prostatectomy or radiation therapy(external beam radiation therapy or brachytherapy);
  • Have access to a personal computer with Internet access (either in home or at a community center);
  • years of age or older;
  • Able to communicate in English
  • Able to give consent

You may not qualify if:

  • Unable to use a computer
  • Unable to communicate in English
  • unable to use a computer
  • unable to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rutgers Cancer Insititute of New Jersey

Somerset, New Jersey, 08873, United States

Location

Icahn School of Medicine at Mt Sinai

New York, New York, 10029, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • Marziliano A, Diefenbach MA, Hudson SV, Tagai EK, Handorf EA, Bator A, Miller SM. Demographic and Psychosocial Characteristics Associated With Use of a Prostate Cancer Survivorship Website: Implications From a Multisite Randomized Controlled Trial. J Med Internet Res. 2022 Mar 21;24(3):e27890. doi: 10.2196/27890.

    PMID: 35311678DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Helio Progress

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Suzanne Miller
Organization
Fox Chase Cancer Center
Suzanne.Miller@fccc.edu
215-728-4069

Study Officials

  • Suzanne Miller, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 25, 2014

Study Start

February 1, 2012

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 12, 2021

Results First Posted

October 12, 2021

Record last verified: 2021-10

Locations

US(3)