Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment

Malignant Neoplasm Clinical Trial

Official title:

A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360814
• Other study ID #: MC0491
• Secondary ID: NCI-2011-00670MC
• Status: Completed
• Start date: January 2005
• Est. completion date: July 2, 2018

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This randomized clinical trial studies structured multidisciplinary intervention or standard medical care in improving quality of life (QOL) in patients receiving active cancer treatment. A structured multidisciplinary intervention may improve the QOL in patients receiving treatment for cancer. It is not yet known whether structured multidisciplinary intervention is more effective than standard medical care in improving QOL

Description:

PRIMARY OBJECTIVES:

I. To examine the efficacy of a structured multidisciplinary intervention compared to standard medical care on improving the subject's QOL as measured by the Functional Assessment of Cancer Therapy-General global summary score (FACT-G) at 4 weeks (or at end of the intervention), at 27 weeks and at 52 weeks.

SECONDARY OBJECTIVES:

I. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the subject's psychosocial functioning as measured by the 11 Linear Analogue Self Assessment (LASA) QOL scales, Profile of Mood States (POMS), the Functional Assessment of Chronic Illness Therapy-Spiritual well-being scale (FACIT-SP), Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors at 4 weeks (or at end of intervention), at 27 weeks and at 52 weeks.

II. To examine the effect of a structured multidisciplinary intervention compared to standard medical care on improving the caregiver's QOL as measured by the Caregiver QOL-Cancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS at 4, 27 and 52 weeks.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: Patients receive six 90-minute sessions of multidisciplinary structured intervention comprising physical therapy, education, a cognitive-behavioral intervention, discussion and support, spiritual reflection, and a relaxation exercise over 2-4 weeks. Caregivers are invited to sessions 1, 3, 4, and 6. Patients may also receive brief telephone contact during the 6 month follow-up period.

GROUP B: Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.

After completion of study treatment, patients are followed up at 4 weeks (or at the end of intervention), at 27 weeks, and at 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2, 2018
• Est. primary completion date: March 13, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to attend all treatment sessions and follow-up

• Ability to provide written informed consent

• Ability to participate in all aspects of the study

• Initial diagnosis of cancer must have been =< 12 months prior to study entry

• Intermediate to poor prognosis, defined as an expected 5-year survival of 0-50% in the judgment of the physicians entering the patient on the study

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2

• >= 1 week of planned cancer treatment at Mayo Clinic

• Has a caregiver also willing to participate

Exclusion Criteria:

• Mini-mental state examination (MMSE) scores of < 20

• Expected survival of < 6 months

• Active substance abuse (alcohol or drug)

• Participation in other psycho-social research trials

• Active thought disorder (bipolar illness, schizophrenia, etc.)

• Suicidal intent or plan

• In need of psychiatric hospitalization

• Recurrent disease after disease-free interval of > 6 months

• Previous cancer =< 5 years (except non-melanoma skin cancer and/or second cancer diagnosed at approximately the same time as this cancer)

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• quality-of-life assessment
Ancillary studies

Behavioral:
• telephone-based intervention
Receive multidisciplinary structured intervention

Other:
• questionnaire administration
Ancillary studies
• counseling intervention
Receive multidisciplinary structured intervention

Behavioral:
• exercise intervention
Receive multidisciplinary structured intervention

Other:
• educational intervention
Receive multidisciplinary structured intervention

Behavioral:
• telephone-based intervention
Receive standard care

Procedure:
• standard follow-up care
Receive standard care

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score	The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze QOL.	At baseline and 4, 27, and 52 weeks
Secondary	On improving the subject's psychosocial functioning as measured by the 11 LASA QOL scales, Profile of Mood States (POMS), the FACIT-SP, Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Control Preferences Scale, and Exercise Behaviors	The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze.	At baseline and 4, 27, and 52 weeks
Secondary	On improving the caregiver's QOL as measured by the Caregiver QOLCancer scale, and on their psychosocial functioning as measured by the 11 LASA QOL scales and POMS	The t-test and Wilcoxon test supplemented by repeated measures analytical procedures (analysis of variance [ANOVA], Generalized Estimating Equations [GEE]) will be used to measure and analyze	At baseline and 4, 27 and 52 weeks