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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01360814
First received: May 23, 2011
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention
Malignant Neoplasm
Procedure: quality-of-life assessment
Behavioral: telephone-based intervention
Other: questionnaire administration
Other: counseling intervention
Behavioral: exercise intervention
Other: educational intervention
Procedure: standard follow-up care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score [ Time Frame: At baseline and 4, 27, and 52 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: At baseline and 4, 27, and 52 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: At baseline and 4, 27 and 52 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 160
Study Start Date: January 2005
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP A (multidisciplinary intervention)
Patients receive six 90-minute sessions of a 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.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Behavioral: telephone-based intervention
Receive multidisciplinary structured intervention
Other: questionnaire administration
Ancillary studies
Other: counseling intervention
Receive multidisciplinary structured intervention
Other Name: counseling and communications studies
Behavioral: exercise intervention
Receive multidisciplinary structured intervention
Other: educational intervention
Receive multidisciplinary structured intervention
Other Name: intervention, educational
Active Comparator: GROUP B (standard medical care)
Patients receive standard medical care only. Patients may also receive brief telephone contact during the 6 month follow-up period.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Behavioral: telephone-based intervention
Receive standard care
Procedure: standard follow-up care
Receive standard care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360814

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Matthew Clark, Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Matthew M. Clark, Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01360814     History of Changes
Other Study ID Numbers: MC0491, NCI-2011-00670, MC0491, 2314-04
Study First Received: May 23, 2011
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 09, 2014