A Finding Balance Writing Intervention for Older Bereaved Caregivers

NCT ID: NCT01416779

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Grief

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Writing Intervention Bereaved Caregivers Older Adults hope inventory of daily widowed life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Writing Group

This group will receive the writing intervention.

Group Type EXPERIMENTAL

Writing Intervention

Intervention Type BEHAVIORAL

Finding Balance Writing Intervention

No Intervention

Non Writing Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Writing Intervention

Finding Balance Writing Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saskatchewan Health Research Foundation

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lorraine Holtslander

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21247803 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-154

Identifier Type: -

Identifier Source: org_study_id