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 (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01360814
First received: May 23, 2011
Last updated: September 3, 2014
Last verified: September 2014

May 23, 2011
September 3, 2014
January 2005
March 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01360814 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Structured Multidisciplinary Intervention or Standard Medical Care in Improving Quality of Life in Patients Receiving Active Cancer Treatment
A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Malignant Neoplasm
  • 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
  • Behavioral: telephone-based intervention
    Receive standard care
  • Procedure: standard follow-up care
    Receive standard care
  • 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.
    Interventions:
    • Procedure: quality-of-life assessment
    • Behavioral: telephone-based intervention
    • Other: questionnaire administration
    • Other: counseling intervention
    • Behavioral: exercise intervention
    • Other: educational intervention
  • 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.
    Interventions:
    • Procedure: quality-of-life assessment
    • Other: questionnaire administration
    • Behavioral: telephone-based intervention
    • Procedure: standard follow-up care
Chock MM, Lapid MI, Atherton PJ, Kung S, Sloan JA, Richardson JW, Clark MM, Rummans TA. Impact of a structured multidisciplinary intervention on quality of life of older adults with advanced cancer. Int Psychogeriatr. 2013 Dec;25(12):2077-86. doi: 10.1017/S1041610213001452. Epub 2013 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Not Provided
March 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01360814
MC0491, NCI-2011-00670, MC0491, 2314-04
Yes
Mayo Clinic
Mayo Clinic
Not Provided
Study Chair: Matthew Clark, Ph.D. Mayo Clinic
Mayo Clinic
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP