GriefNCT01416779
A Finding Balance Writing Intervention for Older Bereaved Caregivers
A study testing Writing Intervention in people with Grief, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief
- What is being tested?
- Writing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finding Balance: The Experience of Hope for Bereaved Caregivers of Palliative Cancer Patients
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.
Read the detailed 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.
- Conditions
- Grief
- Being tested
- Writing Intervention
- Keywords
- Writing Intervention, Bereaved Caregivers, Older Adults, hope, inventory of daily widowed life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing InterventionBehavioural
Finding Balance Writing Intervention
| Study group | Role | What they receive |
|---|---|---|
| Writing Group | Experimental | This group will receive the writing intervention. Receives: Behavioral: Writing Intervention |
| No Intervention | No intervention | Non Writing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grief
Herth Hope Index, Hogan Grief Scale, Inventory of Daily Widowed Life, Finding Balance Scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Principal investigator, Lorraine Holtslander, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416779
- Sponsor's protocol ID
- 08-154
- Status last verified
- Jul 2012
- First submitted
- 7 Feb 2011
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21247803
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Balance: The Experience of Hope for Bereaved Caregivers of Palliative Cancer Patients
- ClinicalTrials.gov ID
- NCT01416779
- Acronym / sponsor ID
- 08-154
- Conditions
- Grief
- Keywords
- Writing Intervention, Bereaved Caregivers, Older Adults, hope, inventory of daily widowed life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Writing Group | Experimental | Behavioral: Writing InterventionThis group will receive the writing intervention. |
| No Intervention | No intervention | –Non Writing Group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing InterventionFinding Balance Writing Intervention | Behavioural | Writing Group |
Primary outcome
Grief
Time frame: 2 weeks
Herth Hope Index, Hogan Grief Scale, Inventory of Daily Widowed Life, Finding Balance Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Background: PubMed 21247803Holtslander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing Intervention in people with Grief, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grief (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.