NCT01519895

Brief Summary

The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

June 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

January 11, 2012

Last Update Submit

April 14, 2015

Conditions

Psychological Stress

Keywords

quality of lifeanxietystresscarerscolorectal or colon cancer

Outcome Measures

Primary Outcomes (1)

  • Distress level

    Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .

    Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention

Secondary Outcomes (2)

  • Burden of care

    Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention

  • Quality of life

    Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention

Study Arms (2)

Existing care

NO INTERVENTION

routine existing care

Telephone intervention

EXPERIMENTAL

in addition to provide telephone intervention support

Behavioral: Telephone intervention

Interventions

Telephone interventionBEHAVIORAL

counseling and education support

Telephone intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
  • Self identified as formal or informal family caregivers
  • Over 18 years old
  • Chinese
  • Cantonese speaking

You may not qualify if:

  • Cognitive disability
  • Domestic helpers or maids
  • Non Chinese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 852, China

Location

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersColonic Neoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • N F Shum

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Surgery, Colorectal Specialist Nurse, Principal Investigator

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 27, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

CN(1)