NCT02332317

Brief Summary

The purpose of this study is to identify whether patients with newly diagnosed advanced cancer benefit from a 12-week palliative rehabilitation program integrated with standard oncology treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 1, 2021

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

December 30, 2014

Last Update Submit

May 28, 2021

Conditions

Advanced Cancer

Keywords

Advanced cancerEarly integrationPalliative rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Effect of the intervention on "The Primary Problem" chosen by the patient.

    Comparing change from baseline to the weighed average of the 6 and 12-week follow-up of the scale in EORTC-QLQ-C30 that correlates to "The Primary Problem" of the patient (measured as area under the curve (AUC) of the change). If the patient has not chosen a "Primary Problem" the same measurement is done with the general health related quality of life scale.

    6 and 12 weeks

Secondary Outcomes (4)

  • Effect of the intervention on all symptoms and problems present in the EORTC-QLQ-C30 Questionnaire

    6 and 12 weeks

  • Effect of the intervention on worries and symptoms of anxiety and depression

    6 and 12 weeks

  • All cause mortality

    3 months after last data collection

  • Economic consequences

    3 months after last data collection

Study Arms (2)

Control arm

NO INTERVENTION

150 patients will receive standard oncology treatment.

Intervention arm

ACTIVE COMPARATOR

150 patients will receive standard oncology treatment alongside a 12-week specialized palliative rehabilitation program

Behavioral: Palliative rehabilitation

Interventions

Palliative rehabilitationBEHAVIORAL

12-week individually customized, specialized palliative rehabilitation program

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • Participants must:
  • be fit to receive standard oncology treatment and accepting treatment
  • read and understand Danish
  • sign informed consent

You may not qualify if:

  • unability to cooperate in the study
  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (2)

  • Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial. Palliat Med. 2021 Jul;35(7):1344-1355. doi: 10.1177/02692163211015574. Epub 2021 May 17.

    PMID: 34000886DERIVED

  • Nottelmann L, Groenvold M, Vejlgaard TB, Petersen MA, Jensen LH. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol. BMC Cancer. 2017 Aug 23;17(1):560. doi: 10.1186/s12885-017-3558-0.

    PMID: 28835218DERIVED

Study Officials

  • Henrik Jensen, Assoc. prof.

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 6, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

June 1, 2021

Record last verified: 2018-09

Locations

DK(1)