NCT00182234

Brief Summary

This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2005

Typical duration for phase_3

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

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2009

Conditions

Continuity of CareQuality of Life

Keywords

unmet supportive care needs

Outcome Measures

Primary Outcomes (3)

  • Difference in unmet supportive care needs between intervention and control group

    2 to 3 weeks after baseline; 8 to 10 weeks after baseline

  • Difference in continuity of care between intervention and control group

    2 to 3 weeks after baseline; 8 to 10 weeks after baseline

  • Difference in quality of life between intervention and control group

    2 to 3 weeks after baseline; 8 to 10 weeks after baseline

Secondary Outcomes (3)

  • Difference in uncertainty in illness between intervention and control group

    2 to 3 weeks after baseline; 8 to 10 weeks after baseline

  • Difference in use of resources between intervention and control group

    2 to 3 weeks after baseline; 8 to 10 weeks after baseline

  • Acute stress following surgery

    8 to 10 weeks after baseline

Interventions

Community Interlink ProgramBEHAVIORAL

The study intervention is a referral to a specialized oncology nursing program. The standardized care provided by this program includes comprehensive assessment and care planning specific to breast and colorectal cancers during the initial phases of treatment, with a minimum of two home visits. Through consultation with the patient, nurses either provide direct (non-medical) care to address needs identified and/or coordinate linkage to services in the community.

Also known as: Interlink Community Cancer Nurses

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed breast or colorectal cancer.
  • In the initial stages of surgical consultation within the randomized surgical practices.
  • Not had previous or concomitant malignancies (except for: non-melanoma skin cancer, or carcinoma in situ of the cervix).
  • Have been informed of cancer diagnosis by the surgical office.
  • Reside in the Interlink adult program service area.
  • Legally able to provide informed consent (18 years of age or older).
  • Able to speak and read English.
  • Patients from an intervention designated practice, must agree to referral to Interlink and to receiving an in-home needs assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sussman J, Bainbridge D, Whelan TJ, Brazil K, Parpia S, Wiernikowski J, Schiff S, Rodin G, Sergeant M, Howell D. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial. Support Care Cancer. 2018 May;26(5):1533-1541. doi: 10.1007/s00520-017-3981-4. Epub 2017 Nov 30.

    PMID: 29189967DERIVED

Study Officials

  • Jonathan Sussman, MD, CCFP, FRCP (c), MSc

    Supportive Cancer Care Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

December 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-06