ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614001268639

Ethics application status

Approved

Date submitted

23/11/2014

Date registered

4/12/2014

Date last updated

10/09/2020

Date data sharing statement initially provided

20/02/2019

Date results information initially provided

20/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Benefits of home-based multidisciplinary
rehabilitation in non small cell lung cancer

Scientific title

In people with inoperable non small cell lung cancer, what is the effect of home-based multi-disciplinary rehabilitation compared to usual care, on physical function, symptoms and health related quality of life?

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

rehabiliTation In lunG cancER - The TIGER trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non small cell lung cancer

Condition category

Condition code

Cancer

Lung - Non small cell

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In addition to usual care, participants will receive a structured multidisciplinary intervention including a personalised aerobic and resistance exercise program, goal setting and follow up in one to one phone and home visit consultations and symptom self-care education as outlined below. The aim is to increase general physical function levels, adherence with exercises through behaviour change and symptom management support. The initial physiotherapy session will be performed in the participant’s home, followed by weekly, scripted telephone contact to monitor exercise adherence and progress exercises and up to 2 additional home visits as required. Participants will also receive weekly nursing telephone intervention to monitor symptoms and provide self-care education. At the completion of the eight week home based program, a maintenance exercise program will be prescribed for each participant individually, with monthly physiotherapy telephone contact to monitor adherence and progress to the final 6 month time point.
Physical intervention: Will include both aerobic and resistance exercise training. Exercise intensity for each participant will be guided using a modified Borg Scale for perceived exertion/breathlessness (scale 0-10) aiming for exercise to be performed in the range of 4-5 (somewhat strong exertion). This will permit prescription of the same relative intensity across participants and allow participants to guide and monitor their own exercise effort to minimise likelihood of the exercises being too strenuous. Partners/carers will be encouraged to motivate participants as well as participate in the exercises, diary entry and measurement sessions. Participants will be taught all exercises by trained physiotherapists at an initial one hour face-to-face session.
The resistance exercise package will incorporate upper and lower limb exercises performed in the participant’s home using hand weights. Functional exercises, easy to perform at home, will also be included to assist in strength training (eg; step ups, sit to stand). Exercise dosage will be prescribed following an initial 10RM. With participants completing up to 80% of their 10RM and 2-3 sets of each exercise. Resistance exercises will be performed at least three days per week for 20 minutes and logged into activity diaries. Participants will be provided with a smartphone during the 8-week program and will receive one SMS reminder per day to act as a prompt to complete their exercise regime. They will also be able to use the smartphone to monitor their daily physical activity (steps taken and distance walked). Participants will be provided with a resistance exercise DVD and encourage to view this weekly to remind them of the accurate performance of each exercise.
The aerobic component will consist of prescribed walking exercise. The aim of the walking program will be to progress to walking for a minimum of 150 minutes in total per week at a moderate intensity, as recommended by the guidelines for lung cancer. Walking may be undertaken in bouts of 10 minutes or in one block of 30mins or more. Defined, individualized outdoor physical activity will be prescribed to each subject by the physiotherapist and monitored using a combination of mapping and GPS software. Safety: Participants will be advised not to start exercising if they have a fever (>38 degrees Celsius), or have any new onset chest pain and will be provided with a contact number to ring if they or their partner/carer are concerned. They will be advised to stop exercising if they experience any new chest pains or are too breathless to be able to speak. Participants will be encourage to record details of daily aerobic and resistance exercises into an exercise diary.

Symptom management and behaviour change support sessions: The model used for behaviour change support is the Health Change Australia Model of Behaviour Change. The aim is to build motivation and self-efficacy by identifying and addressing individual barriers to the recommended resistance training and cardiovascular exercise goals and thus initiate and sustain new physical activity behaviours. The physiotherapist will use the behaviour change model to establish the motivation level to participate and set individualised participant goals.
Self-care requirements will be assessed at each 15 minute, scripted nursing telephone session where the nurse will use the validated Edmonton symptom assessment system to identify areas of individual unmet physical and emotional need. The aim of the initial nursing intervention session is to ensure symptoms that might interfere with exercise are addressed. Evidence based self-management information for specific symptoms will be provided to patients during these sessions. In addition, patients will be referred for further assessment and treatment by the medical team if more severe uncontrolled symptoms or side-effects are identified.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

Non-standardised information about the disease, its treatment and side- effects will be provided by the treatment team as per usual practice. All patients, including those allocated to usual care will receive 2 booklets: on lung cancer diagnosis and treatment and exercise for people living with cancer produced by Cancer Council Victoria. Participants will also report (via telephone calls from our research assistant every 4 weeks) their levels of exercise during the intervention.

Control group

Active

Outcomes

Primary outcome [1]

Functional exercise capacity (Six minute walk test)

Timepoint [1]

9 weeks post baseline assessment

Secondary outcome [1]

Physical activity (Sensewear accelerometer worn for 7 days)

Timepoint [1]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [2]

Activity motivation (The Behavioural Regulation in Exercise Questionnaire (BREQ-2))

Timepoint [2]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [3]

Activity Self–Efficacy (Physical Activity Assessment Inventory)

Timepoint [3]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [4]

Muscle strength (quadriceps and hand-grip assessed using hand held dynamometry).

Timepoint [4]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [5]

Quadriceps cross-sectional area measured using ultrasound

Timepoint [5]

Baseline and 9 weeks post baseline assessment

Secondary outcome [6]

Health related quality of life: Functional Assessment of Cancer Therapy- Lung (FACT-L)

Timepoint [6]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [7]

Health related quality of life: Assessment of Quality of Life (AQoL)

Timepoint [7]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [8]

Psychological distress: Hospital Anxiety and Depression Scale total scale (HADS-T)

Timepoint [8]

Baseline, 9 weeks and 6 months post baseline assessment

Secondary outcome [9]

Symptom interference: The MD Anderson Symptom Inventory (MDASI-LC)

Timepoint [9]

Baseline, 9 weeks and 6 months post baseline assessment.

Secondary outcome [10]

Resilience: Connor Davidson Resilience Scale

Timepoint [10]

Baseline, 9 weeks and 6 months post baseline assessment.

Secondary outcome [11]

Frailty: The Clinical Frailty Scale

Timepoint [11]

Baseline

Secondary outcome [12]

Cost-effectiveness: health economic questionnaire, MBS/PBS data.

Timepoint [12]

9 weeks, 4 and 6 months post baseline assessment

Secondary outcome [13]

Physical activity: International Physical Activity Questionnaire (IPAQ-SF).

Timepoint [13]

Following completion of the 7 day activity monitoring periods at baseline, 9 weeks and 6 months post baseline assessment.

Secondary outcome [14]

Qualitative participant feedback: Semi-structured qualitative interviews including standardised questions will be conducted in a subset of 10 participants from each study arm.

Timepoint [14]

baseline and 9 weeks.

Secondary outcome [15]

Survival - in addition to collecting this information from hospital medical records a change to the study protocol has been approved by multi-site HREC review to allow us to obtain date and cause of death information from the Registry of Births, Deaths and Marriages for the participants in our study.

Timepoint [15]

censored at 3 years post baseline assessment

Secondary outcome [16]

Venous blood samples (inflammatory markers)

Timepoint [16]

Baseline and 9 week post baseline assessment.

Eligibility

Key inclusion criteria

Inclusion criteria: Eligible patients will have a histologically confirmed diagnosis of inoperable, NSCLC; be scheduled to receive treatment other than surgery (radiotherapy, chemotherapy, targeted therapy); be aged 18 years or older; be able to read and write English; have an Eastern Co-operative Oncology Group performance status of 0-2 and Clinical Frailty Scale score of less than 7 at study entry; have a physician rated estimated life expectancy of greater than or equal to 6 months; have primary attending oncologist approval; have been sedentary in the past month (i.e., patients not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if they have: pelvic or lower limb bony metastases, an unstable psychiatric or cognitive disorder; presence of a concurrent, actively treated other malignancy or history of other malignancy treated within the past one year (or three if treatment within the vicinity of the lung fields eg. radiotherapy for breast or oesophageal cancer), other than non-melanoma skin cancer or in-situ melanoma, or have any other comorbidities preventing participation in a land based exercise program.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Potentially eligible participants will be identified through screening clinic lists with eligibility and suitability confirmed by the primary treating oncologist. Participants will be recruited at diagnosis; provide written informed consent; complete baseline assessment and then be randomly allocated. Following informed consent participants will be randomized 1:1 to either the intervention or usual care arms. Randomisation will be remotely and independently performed using random number generation and stratified group allocation will be concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

To ensure randomized groups are similar at baseline, we will stratify based upon cancer treatment type (radical versus palliative). Random order generation will be performed by permuted block randomisation created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

For the primary outcome (6MWT) our pilot (n=50) variability around the 6MWT change in lung cancer was a standard deviation change of 68m with a deterioration in 6MWT distance of -48m (at 2 months). To maintain (or improve) the 6MWT distance following rehabilitation we will need to recruit 32 participants per group for 80% power at alpha = 0.05 (two tailed). Thus including 30% attrition (pilot data 25%) we need to recruit a total sample of 92 participants.
The analysis will be by intention-to-treat principles: all randomised patients will have data collection until the end of study or they withdraw, and all patients will be included in the analyses. Baseline characteristics will be summarized by group and reported as mean (SD) for normally distributed data, median (IQR) for non-normally distributed data or as proportions. Possible consent bias will be assessed using logistic regression analyses including demographic and clinical variables. Possible differential attrition will be assessed by comparison of two proportions, using chi squared analyses, for those who die or withdraw and those who remain in the study. Analysis of our primary outcome, 6MWT, at two months will be undertaken by two group comparison using either parametric or non-parametric (or bootstrapping) methods depending on assumptions of data. Multiple imputation will be performed to deal with data missing due to loss to follow up and ‘0’ will be assigned for the 6MWT distance where participants are deceased.
For analyses of the 6MWT involving the three time points (baseline, two months and six months) and secondary outcomes, we will use a linear mixed model in which the subject is a random effect, and treatment group and time are fixed effects. Alpha will be set at 0.05 for all analyses and all tests will be two-sided. Data from the questionnaires and semi structured interviews will be collated and summarized. Qualitative data will be transcribed verbatim, entered into a qualitative data management software program and thematic analyses undertaken to identify key barriers and facilitators of physical activity and factors impacting adherence over time. Survival curves will be described using Kaplan-Meier method and compared using stratified logrank tests

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2014

Actual

5/12/2014

Date of last participant enrolment

Anticipated

5/12/2016

Actual

14/12/2016

Date of last data collection

Anticipated

14/12/2019

Actual

14/12/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [3]

Peter MacCallum Cancer Institute - East Melbourne

Recruitment postcode(s) [1]

3002 - East Melbourne

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment postcode(s) [3]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Linda Denehy

Address

University of Melbourne
Level 7, 161 Barry St
Parkville
Victoria
3010

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Sanchia Aranda

Address [1]

University of Melbourne
Level 6, 161 Barry St
Parkville
Victoria
3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre

Ethics committee address [1]

St Andrews Place
East Melbourne
Victoria
3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/06/2014

Ethics approval number [1]

HREC/14/PMCC/27

Summary

Brief summary

The goal of this innovative trial is to test a multidisciplinary home based package of exercise, patient self-management and motivational strategies aimed at improving functional exercise capacity in people with inoperable non-small cell lung cancer (NSCLC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a confirmed diagnosis of inoperable NSCLC, are scheduled to receive treatment other than surgery (radiotherapy, chemotherapy, targeted therapy), and do not regularly partake in exercise. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the intervention package, which comprises 1) a home-based, eight week exercise program including resistance exercises and a walking program and 2) disease self-management education including symptom management and promotion of exercise adherence using behaviour modification strategies with phone follow up. Participants in this group will receive a 1 hour initial home visit from a physiotherapist together with weekly telephone follow-up calls from both the physiotherapist and nurse and up to 2 further physiotherapy home visits if needed. Participants in the second group will receive usual care, which includes 2 booklets: on lung cancer diagnosis and treatment and exercise for people living with cancer produced by Cancer Council Victoria. All participants will undergo assessments of functional exercise capacity, and complete a number of questionnaires at baseline, 9 weeks and 6 months in order to assess quality of life, survival and resource use. This research is clinically based, relevant and aimed at improving the quality of survival of people with NSCLC. The research is designed to be clinically feasible and cost-effective and has the capacity to be widely disseminated and adopted into practice guidelines in this large and vulnerable group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Linda Denehy

Address

University of Melbourne
Level 7, 161 Barry St
Parkville
Victoria
3010

Country

Australia

Phone

61 3 8344 4171

Fax

l.denehy@unimelb.edu.au

Contact person for public queries

Name

Ms Lara Edbrooke

Address

University of Melbourne
Level 7, 161 Barry St
Parkville
Victoria
3010

Country

Australia

Phone

61 3 8344 5377

Fax

larae@unimelb.edu.au

Contact person for scientific queries

Name

Prof Linda Denehy

Address

University of Melbourne
Level 7, 161 Barry St
Parkville
Victoria
3010

Country

Australia

Phone

61 3 8344 4171

Fax

l.denehy@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data that underlie the results reported in published articles, after
deidentification (text, tables, figures, and appendices).

When will data be available (start and end dates)?

Beginning 9 months and ending 36 months following article publication

Available to whom?

Researchers who provide a methodologically sound proposal.

Available for what types of analyses?

To achieve the aims of the proposal.

How or where can data be obtained?

Proposals should be directed to l.denehy@unimelb.edu.au To gain access data
requestors will need to sign a data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9118	Study protocol	Edbrooke, L, Aranda S, Granger CL, McDonald C, Krishnasamy M, Mileshkin, L, Irving L, Braat S, Clark R, Gordon I, Denehy L. Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a Phase II randomised controlled trial. BMC Cancer, 2017; 17(1): 663.
9119	Statistical analysis plan	Edbrooke, L,… Denehy, L. Multidisciplinary home-based rehabilitation in inoperable lung cancer: a randomised controlled trial. Thorax 2019, doi:10.1136/thoraxjnl-2018-212996 The statistical analysis plan is available as a supplementary file to this publication.

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Edbrooke, L,… Denehy, L. Multidisciplinary home-ba... [More Details]
Study results article	Yes	Edbrooke, L, Denehy, L, Granger, CL, Kapp, SK and ... [More Details]
Study results article	Yes	Edbrooke, L,… Denehy, L. Physical Activity Levels ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Exercise training for advanced lung cancer.	2019	https://dx.doi.org/10.1002/14651858.CD012685.pub2
Embase	Physical activity levels are low in inoperable lung cancer: Exploratory analyses from a randomised controlled trial.	2019	https://dx.doi.org/10.3390/jcm8091288
Embase	Evaluating a web- and telephone-based personalised exercise intervention for individuals living with metastatic prostate cancer (ExerciseGuide): protocol for a pilot randomised controlled trial.	2021	https://dx.doi.org/10.1186/s40814-020-00763-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically