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Malignant NeoplasmNCT01360814

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

An observational study of Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasm
What is being tested?
quality-of-life assessment, telephone-based intervention and questionnaire administration
How many people
138 participants
Where
1 siteUnited States
Study dates
Jan 2005to 2 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
quality-of-life assessment, telephone-based intervention, questionnaire administration, counseling intervention, exercise intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • telephone-based interventionBehavioural

    Receive multidisciplinary structured intervention

  • questionnaire administrationOther

    Ancillary studies

  • counseling interventionOther

    Also called counseling and communications studies

    Receive multidisciplinary structured intervention

  • exercise interventionBehavioural

    Receive multidisciplinary structured intervention

  • educational interventionOther

    Also called intervention, educational

    Receive multidisciplinary structured intervention

  • telephone-based interventionBehavioural

    Receive standard care

  • standard follow-up careProcedure or surgery

    Receive standard care

Study groups in NCT01360814
Study groupRoleWhat they receive
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.
Receives: Procedure: quality-of-life assessment; Behavioral: telephone-based intervention; Other: questionnaire administration; Other: counseling intervention; Behavioral: exercise intervention; Other: educational intervention
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.
Receives: Procedure: quality-of-life assessment; Other: questionnaire administration; Behavioral: telephone-based intervention; Procedure: standard follow-up care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and 4, 27, and 52 weeks

Secondary outcomes (2)

  1. 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.

    Measured: At baseline and 4, 27, and 52 weeks

  2. 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

    Measured: At baseline and 4, 27 and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2011 (estimated)
  2. Study startJan 2005
  3. Primary completion13 Mar 2009
  4. Study completion2 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360814
Sponsor's protocol ID
MC0491
Other IDs
NCI-2011-00670, MC0491, 2314-04
Status last verified
May 2019
First submitted
23 May 2011
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24001635

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

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