MDACC Study Summary 2007-0503

Study Summary
No. 2007-0503:.......Other Studies......Eduardo Bruera......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2007-0503

Study Title:	Emotional Disclosure Through Expressive Writing in Caregivers of Patients Receiving Palliative Care and in the Bereavement Phase: a Pilot Study

Physician

New Patient Referral



Name:	Eduardo Bruera	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Other Studies	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Not Applicable

Treatment Agents:	Psychosocial	Home Care:	Not Applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not Applicable


Description/ Intervention:	The goal of this research study is to measure any health-related effects of expressive writing for caregivers of cancer patients who either are receiving palliative care or passed away 1 to 2 months ago from cancer.

Study Objectives / Outcomes

Primary objective:

Our primary objective is to determine if expressive writing is a feasible psychosocial intervention for caregivers of patients with advanced cancer referred to a palliative care program or during their bereavement phase.

Secondary objectives:
1. To determine whether expressive writing is capable of decreasing the anxiety level of caregivers of advanced cancer patients receiving palliative care (PC Group) as determined by differences between the State Trait Anxiety Inventory scores in an Expressive Writing (EW) and a Neutral Writing (NW) group.
2. To determine whether expressive writing is capable of decreasing caregivers' grief as determined by the differences between the Texas Revised Grief Inventory scores in an Expressive Writing (EW) and a Neutral Writing (NW) group.
3. To determine whether expressive writing can be a useful psychosocial intervention for caregivers of patients receiving palliative care or in the bereavement phase as determined by the differences between the following assessments in an Expressive Writing (EW) and a Neutral Writing (NW) group: the Impact of Event Scale; the Pittsburgh Sleep Quality Index; the Perceived Stress Scale; the Medical Outcomes Study 20-item Short Form Health Survey; and for the PC Group only, the Caregiver Quality of Life Scale – Cancer.

Study Status Information



Study Activation / Registration Date:	11/06/2007

IRB Review and Approval Date:	11/06/2007

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) (For the PALLIATIVE CARE GROUP) Caregivers of patients with advanced cancer referred to palliative care clinic.

2) (For the PALLIATIVE CARE GROUP) Participants must have a State-Trait Anxiety Inventory (state subscale, STAI-S) score of at least 40.

3) (For the BEREAVEMENT GROUP) Caregivers of recently (4 to 8 weeks) deceased advanced cancer patients who died at M. D. Anderson Cancer Center.

4) (For the BEREAVEMENT GROUP) Participants must have a Texas Revised Grief Inventory score of at least 34 in the "present feelings" subscale.

5) (For both groups) Caregivers must be 18 years of age or older as the assessment tools used in this study have not been validated in the pediatric population.

6) (For both groups) Caregiver is defined as a person indicated by the patient who is responsible for providing the majority of the unpaid, informal activities involved in her/his care in the home setting.

7) (For both groups) Caregivers must be able to read, write, and speak English so that they can understand the questionnaires and participate in the interventions (the qualitative analysis will be conducted only in English).

8) (For both groups) Caregivers will have normal cognitive status as determined by the interviewer and by their ability to understand the nature of the study and consent process.

9) Caregivers in the Palliative Care group must sign informed consent. Caregivers in the bereavement group will give telephone verbal consent.

Exclusion Criteria:

1) Caregivers who report preexisting psychiatric diseases or under psychiatric care. Participants will be excluded if answered "Yes" to any of the following questions: "Have you ever received the diagnostic of any psychiatric disease?" and "Have you ever received treatment for any psychiatric disease?".

2) Caregivers who are found to screen positive for severe mood disorders according to the HADS questionnaire for anxiety and/or depression (greater or equal to 20). They will be immediately referred to their primary care physician for initial assessment and management.

3) Caregivers who are being actively treated for advanced cancer.

Links

Registration Number: Not Applicable Clinical Trial