MDACC Study Summary ID01-665

Study Summary
No. ID01-665:.......Lung......Cindy Carmack Taylor......Behavioral Science

Study Summary Title



Study Summary Number:	ID01-665

Study Title:	Spousal Relationships and Adjustment in Lung Cancer

Physician

New Patient Referral



Name:	Cindy Carmack Taylor	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3582 Contact us about clinical trials

General Information



Disease Group:	Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	None, other than regularly scheduled clinic appointments.

Treatment Agents:	None	Home Care:	Participants may complete the questionnaire packets at home. No treatment will be provided during this study.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this psychosocial research study is to look at factors that may affect the quality of life of patients with lung cancer and their spouses.

Study Objectives / Outcomes

This study comprises two parts and includes qualititative interviews with lung cancer patients and spouses of lung cancer patients and a longitudinal assessment of the psychological and relationship functioning of lung cancer patients and spouses. The specific aims are to: (1) determine the prevalence of distressed patients, spouses and spousal relationships in lung cancer over time; (2) determine whether the prevalence of distressed spousal relationships is higher in relationships where the patient, spouse, or both smoke following diagnosis; (3) characterize the associations among patient psychological functioning, spouse psychological functioning, relationship functioning, and caregiver burden from diagnosis to 6 months following diagnosis; (4) determine baseline predictors of caregiver burden at 3 and 6 months following diagnosis; and (5) conduct qualitative interviews with lung cancer patients and spouses of lung cancer patients and to use this information to refine an existing measure of relationship communication related to lung cancer, its treatment, and health behaviors.

Study Status Information



Study Activation / Registration Date:	08/27/2002

IRB Review and Approval Date:	06/24/2002

Study Type:	Therapeutic

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) Part 1: Eligibility criteria for the patient includes: (1) being a patient diagnosed with lung cancer for whom treatment has been initiated greater than 3 months prior to enrollment in the study; (2) having an ECOG Performance Status Score of 2 or less; (3) having the ability to read and speak English well enough to understand the consent form; (4) being able to provide informed consent; (5) having the spouse or significant other with whom they have resided for at least 1 year; and (6) either the patient, spouse, or both have ever smoked.

2) Part 1: Eligibility criteria for the spouse includes (1) being the spouse or significant other of a patient diagnosed with lung cancer; (2) having the patient's consent to be contacted; (3) having the ability to read and speak English well enough to understand the consent form; and (4) being able to provide informed consent.

3) Part 2: Eligibility criteria for the patient includes (1) being a patient diagnosed with lung cancer; (2) not having initiated treatment or being within one month of treatment initation at the time of enrollment in the study; (3) having an ECOG Performance Status Score of 2 or less; (4) having the ability to read and speak English; (5) being able to provide informed consent; and (6) having a spouse or significant other with whom she/he has resided for at least 1 year.

4) Part 2: Eligibility criteria for the spouse includes (1) being the spouse or significant other of a patient diagnosed with lung cancer; (2) having the patient's consent to be contacted; (3) having the ability to read and speak English; and (4) being able to provide informed consent.

5) Optional Procedure for Part 2: Participants must meet eligibility for the main study part 2, and also currently reside in Texas.

Exclusion Criteria:

1) For both the patient and the spouse not being able to provide informed consent.

2) Less than 18 years of age.

Links

Registration Number: Not Applicable Clinical Trial