NCT01416779

Brief Summary

The overall purpose of this study is to develop and pilot-test a theory-based psychosocial supportive "finding balance" intervention for older, bereaved spousal caregivers of a palliative cancer patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1.3 years

First QC Date

February 7, 2011

Last Update Submit

July 15, 2012

Conditions

Grief

Keywords

Writing InterventionBereaved CaregiversOlder Adultshopeinventory of daily widowed life

Outcome Measures

Primary Outcomes (1)

  • Grief

    Herth Hope Index, Hogan Grief Scale, Inventory of Daily Widowed Life, Finding Balance Scale

    2 weeks

Study Arms (2)

Writing Group

EXPERIMENTAL

This group will receive the writing intervention.

Behavioral: Writing Intervention

No Intervention

NO INTERVENTION

Non Writing Group

Interventions

Writing InterventionBEHAVIORAL

Finding Balance Writing Intervention

Writing Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women and men, ages 60 and over, who previously resided with and provided care for a spouse with terminal cancer who died within the last year, English speaking, and freely consenting to be involved in the study.

You may not qualify if:

  • will be those cognitively impaired, non-autonomous, or not able to give a free and informed consent, as determined by the registered nurse research assistant on initial contact.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • Holtslander LF, Bally JM, Steeves ML. Walking a fine line: an exploration of the experience of finding balance for older persons bereaved after caregiving for a spouse with advanced cancer. Eur J Oncol Nurs. 2011 Jul;15(3):254-9. doi: 10.1016/j.ejon.2010.12.004. Epub 2011 Jan 17.

    PMID: 21247803BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2011

First Posted

August 15, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

CA(1)