NCT01432197

Brief Summary

The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P75+ for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
Last Updated

September 12, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

September 8, 2011

Last Update Submit

September 9, 2011

Conditions

HRQOL (Health Related Quality of Life)

Keywords

HRQOLOccupational therapyADL interventionCancer patients

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    15 months

Secondary Outcomes (1)

  • Ability to perform activities of daily living

    15 months

Study Arms (2)

Occupational therapy intervention

EXPERIMENTAL

Intervention group: Standard treatment and care added with an ADL intervention program: 1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs. Control group: Standard treatment and care. No occupational therapy intervention.

Other: ADL intervention

Standard treatment and care

NO INTERVENTION

Control group: Standard treatment and care. No occupational therapy intervention.

Interventions

ADL interventionOTHER

1\) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.

Occupational therapy intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients
  • Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
  • Able to read and understand Danish

You may not qualify if:

  • Referred to occupational therapy before study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of General Practice, IST, University of Southern Denmark

Odense, 5000, Denmark

Location

Study Officials

  • Dorte Gilsaa Hansen, Ph.D, M.D.

    Research Unit of General Practice, IST, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Karen la Cour, Ph.D, OT, MSc

    Health, Man and Society, IST, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D student, OT, MPH

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Last Updated

September 12, 2011

Record last verified: 2011-09

Locations

DK(1)