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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01416779
Other study ID # 08-154
Secondary ID
Status Completed
Phase N/A
First received February 7, 2011
Last updated July 15, 2012
Start date February 2011
Est. completion date June 2012

Study information

Verified date July 2012
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Description:

Research devoted to determining the efficacy of bereavement interventions remains a top priority. The development of theory-based, acceptable and feasible psychosocial interventions would begin to address the needs of family caregivers. A prominent theory of coping with bereavement, Stroebe and Schut's Dual Process Model, describes oscillation between loss-oriented and restoration-oriented coping; having a balance between these processes predicted more positive outcomes for older bereaved spouses. Similarly, the process of "finding balance" emerged as a first step in the search for new hope in the PI's grounded theory research with older bereaved family caregivers. They described the importance and difficulty of "finding balance" as they recovered from caregiving and struggled to find a new meaning and purpose for their lives after the loss of a spouse to cancer. An intervention focused on "finding balance" provides an innovative and promising approach to guiding the development of a theory-based psychosocial intervention for family caregivers who become bereaved. In clinical work a highly focused writing intervention has shown important benefits (personal communication, Dr. Robert Neimeyer, March 4, 2009). A validated tool to measure the effectiveness of an intervention to find balance does not exist, however valid existing measures of hope, grief, and an inventory of balance based on the Dual Process Model will be used as proxies. Therefore, 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Writing Intervention
Finding Balance Writing Intervention

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Grief Herth Hope Index, Hogan Grief Scale, Inventory of Daily Widowed Life, Finding Balance Scale 2 weeks No
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