NCT01003574

Brief Summary

This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health outcomes among survivors designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for cardiovascular (CV) screening. This study will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

October 27, 2009

Last Update Submit

November 25, 2013

Conditions

Cardiovascular RiskCancer

Keywords

cardiovascular health outcomes in cancer survivors

Outcome Measures

Primary Outcomes (1)

  • This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the APN phone counseling group will have undergone cardiovascular screening, as compared to the standard care group

    2.5 years

Secondary Outcomes (10)

  • Change in knowledge

    Baseline and 2.5 years post intervention

  • Change in motivation

    Baseline and 2.5 years post intervention

  • Change in fear

    Baseline and 2.5 years post intervention

  • Change in beliefs

    Baseline and 2.5 years post intervention

  • Change in affect

    Baseline and 2.5 years post intervention

  • +5 more secondary outcomes

Study Arms (2)

Control Arm

OTHER

Control arm will receive standard care for risk of cardiac sequelae - a mailed, tailored (neither generic nor targeted) print summary of individualized information about the survivor's treatment, late effects risks, and recommended follow-up and lifestyle modifications.

Behavioral: lifestyle modification and telephone counseling

Test Arm

OTHER

Test arm will receive standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.

Behavioral: lifestyle modification and telephone counseling

Interventions

lifestyle modification and telephone counselingBEHAVIORAL

A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).

Also known as: Cardiovascular Health Outcomes
Control Arm

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Childhood Cancer Survivor Study (CCSS) cohort participants
  • Age 25 years or older
  • No CV screening in previous 5 years
  • Received anthracycline chemotherapy and/or irradiation of the chest
  • Previous history of successful independent (non-surrogate) response to CCSS surveys (reading level for non-medical items is 4th-6th grade Flesch-Kincaid level).

You may not qualify if:

  • Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
  • Inability or unwillingness of research participant to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

  • Hudson MM, Leisenring W, Stratton KK, Tinner N, Steen BD, Ogg S, Barnes L, Oeffinger KC, Robison LL, Cox CL. Increasing cardiomyopathy screening in at-risk adult survivors of pediatric malignancies: a randomized controlled trial. J Clin Oncol. 2014 Dec 10;32(35):3974-81. doi: 10.1200/JCO.2014.57.3493. Epub 2014 Nov 3.

    PMID: 25366684DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Melissa Hudson, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 29, 2009

Study Start

March 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

US(1)