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Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer (PROMISE)

Primary Purpose

Lung Cancer, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients undergoing elective, minimal invasive surgery with intention to cure.
  2. Age between 18 and 80 years.
  3. ECOG 0 - 2 post-surgery.

Exclusion Criteria:

  1. Patients with chronic pain
  2. Previous pulmonary surgery

  3. Comorbidity limiting rehabilitation

    1. Rheumatoid arthritis
    2. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
    3. Muscle disease
    4. Fibromyalgia
    5. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
    6. Psychiatric disorders

Sites / Locations

  • IsalaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

An integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer

Standard of care

Outcomes

Primary Outcome Measures

Quality of life (SF-36)
effects of an integrated multidisciplinary rehabilitation program on general quality of life

Secondary Outcome Measures

SGRQ
health-related quality of life
VAS
post-operative pain
WHO-PS
performance score
6 minute walking distance
exercise tolerance
international physical activity questionnaire, iPAQ
physical activity

Full Information

First Posted
November 17, 2021
Last Updated
August 2, 2022
Sponsor
Isala
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1. Study Identification

Unique Protocol Identification Number
NCT05136300
Brief Title
Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
Acronym
PROMISE
Official Title
Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
An integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation
Other Intervention Name(s)
Pain clinic
Intervention Description
Patients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker. The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months.
Primary Outcome Measure Information:
Title
Quality of life (SF-36)
Description
effects of an integrated multidisciplinary rehabilitation program on general quality of life
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SGRQ
Description
health-related quality of life
Time Frame
12 months
Title
VAS
Description
post-operative pain
Time Frame
12 months
Title
WHO-PS
Description
performance score
Time Frame
12 months
Title
6 minute walking distance
Description
exercise tolerance
Time Frame
12 months
Title
international physical activity questionnaire, iPAQ
Description
physical activity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective, minimal invasive surgery with intention to cure. Age between 18 and 80 years. ECOG 0 - 2 post-surgery. Exclusion Criteria: Patients with chronic pain Previous pulmonary surgery Comorbidity limiting rehabilitation Rheumatoid arthritis Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %. Muscle disease Fibromyalgia Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord) Psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Dinjens
Phone
0384244597
Email
ldinjens@isala.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Stigt
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Dinjens, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

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