NCT01718574

Brief Summary

The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

October 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

October 24, 2012

Last Update Submit

September 5, 2014

Conditions

Cancer

Keywords

self-help booksupport service

Outcome Measures

Primary Outcomes (1)

  • change in Health Education Impact Questionnaire scores

    pre-intervention (week 0), post intervention (week 6), follow-up (week 10)

Secondary Outcomes (1)

  • change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores

    pre-intervention (week 0), post intervention (week 6), follow-up (week 10)

Study Arms (2)

Self-help book

EXPERIMENTAL
Other: Self-help book

Usual Care Control

NO INTERVENTION

Interventions

Self-help bookOTHER

Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses

Self-help book

Eligibility Criteria

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

You may qualify if:

  • + years of age
  • been diagnosed with cancer
  • can read English

You may not qualify if:

  • participating in the "Think Smart, Live Well" group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MUHC Cedars CanSupport

Montreal, Quebec, H3A 1A1, Canada

Location

Hope & Cope, JGH

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Neoplasms

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

October 24, 2012

First Posted

October 31, 2012

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CA(2)