A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial
18 Years
N/A
Both
Malignant Neoplasm
Trial Information
A Structured Multidisciplinary Intervention to Improve Quality of Life of Patients Receiving Active Oncological Treatment: A Randomized Trial
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Cancer patient's quality of life (QOL) as measured by the FACT-G global summary score
Outcome Description:
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.
Outcome Time Frame:
At baseline and 4, 27, and 52 weeks
Safety Issue:
No
Principal Investigator
Matthew Clark, Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
MC0491
NCT ID:
NCT01360814
Start Date:
January 2005
Completion Date:
Related Keywords:
- Malignant Neoplasm
- Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
