Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001283369
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
6/09/2017
Date last updated
28/01/2024
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer And Physical ACtivITY (CAPACITY) trial: A randomised control trial of exercise and self-management for people with lung cancer
Scientific title
Cancer And Physical ACtivITY (CAPACITY) trial: A randomised control trial to evaluate the effect of exercise and self-management on physical function in people with lung cancer
Secondary ID [1] 292321 0
None
Universal Trial Number (UTN)
U1111-1199-3845
Trial acronym
Cancer And Physical ACtivITY (CAPACITY) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 303875 0
Condition category
Condition code
Cancer 303229 303229 0 0
Lung - Non small cell
Physical Medicine / Rehabilitation 303230 303230 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: In addition to usual care, participants randomised to the intervention arm will also receive an exercise and education self-management program after surgery. The intervention implements the American College of Sports Medicine Physical Activity Guidelines for people with cancer (Schmitz et al Med Sci Sports Exer 2005;14). The program consists of a face to face appointment with a physiotherapist occur post-operatively on the hospital ward before discharge. The session can be split over two times/days if needed, with a total duration of 15 to 45 minutes (depending on the needs of the participant). The session(s) include 1) assessing the patient’s readiness for physical activity behavioural change, goals and confidence; 2) verbal education with the patient +/- carers and family about physical activity; 3) provision of resources to support physical activity (including an activity monitor, exercise diary and booklet); 4) setting personalized physical activity goals with the patient and a home program; and 5) identifying barriers and enablers for the patient to achieve the physical activity goals. All participants will be prescribed a home walking program and this will be progressed towards performing 150 minutes per week at a moderate intensity based on the American College of Sports Medicine Physical Activity Guidelines for people with cancer (Schmitz et al Med Sci Sports Exer 2005;14). In addition participants will be prescribed a home resistance training program, using body weight, that are targeting major muscle groups and progressed towards performing this two to three times per week. The exercises including type of exercise, repetition number, frequency and duration are tailored to the individual patient's ability. The intervention is personalised to the individual participant’s needs because patients with lung cancer present with other comorbid disease, including depression and COPD, and therefore to improve efficacy a targeted approach to physical activity is required that addresses the participants individual goals and that can be prescribed from their current physical activity levels.
The patient will receive weekly phone calls to promote adherence to the set physical activity goals, discuss barriers/issues and progress exercise. The phone calls occur weekly after hospital discharge for 3 months. The duration of the phone calls will be 5 to 20 minutes each depending on the needs of the participant. Participants will be asked to keep an exercise diary during the intervention period to record their daily exercises and physical activity levels.
Intervention code [1] 298504 0
Rehabilitation
Comparator / control treatment
Usual medical, nursing and allied health care will be provided to both groups. Usual physiotherapy care does not routinely involve assessment or treatment pre-operatively or after hospital discharge following surgery. Inpatient ward based physiotherapy in the post-operative period (when patients are in hospital after surgery) will be provided to both groups as per usual care and this follows a clinical pathway (as per usual care). The physiotherapist providing the inpatient physiotherapy to both groups will be blinded to group allocation.
Control group
Active

Outcomes
Primary outcome [1] 302615 0
Physical function measured by physical function domain of the European Organization for the Research and Treatment of Cancer Questionnaire (EORTC QLQ C30)
Timepoint [1] 302615 0
The primary time point is 3 months post-operative.
This outcome is also measured at baseline (pre-operatively), and 6 and 12 months post-operative
Secondary outcome [1] 336508 0
Functional exercise capacity measured by the 6 minute walk test distance (6MWT)
Timepoint [1] 336508 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [2] 336509 0
Physical function measured by the Short Physical Performance Battery (SPPB)
Timepoint [2] 336509 0
Measured at baseline (pre-operatively), hospital discharge, 3 and 6 months post-operative
Secondary outcome [3] 336510 0
Walking self-efficacy measured by the Walking Self-efficacy Scale
Timepoint [3] 336510 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [4] 336511 0
Self reported physical activity levels measured by International Physical Activity Questionnaire (IPAQ)
Timepoint [4] 336511 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [5] 336512 0
Sleep measured by the the 8-item Sleep Disturbance Short Form 8b
Timepoint [5] 336512 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [6] 336513 0
Health related quality of life measured with the European Organization for the Research and Treatment of Cancer questionnaire with lung module (EORTC QLQ C30 LC13)
Timepoint [6] 336513 0
Measured at baseline (pre-operatively), and 3, 6 and 12 months post-operative
Secondary outcome [7] 336514 0
Health care usage after surgery measured using patient medical records
Timepoint [7] 336514 0
Measured over 12 months from surgery
Secondary outcome [8] 336515 0
Survival (using patient medical records)
Timepoint [8] 336515 0
Measured over 12 months post-operative and 5 years post-operative
Secondary outcome [9] 337006 0
Quadriceps muscle function measured using ultrasound.
Timepoint [9] 337006 0
Measured at within 48 hours following surgery, and 3 and 6 months post-operative
Secondary outcome [10] 338424 0
Barrier and task self-efficacy measured using the Barrier and Task Self Efficacy Scale
Timepoint [10] 338424 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [11] 338427 0
Self reported physical activity levels measured using the Physical Activity Scale for the Elderly (PASE)
Timepoint [11] 338427 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [12] 338429 0
Objectively measured physical activity levels measured using accelerometry worn on the wrist during waking hours for 7 consecutive days
Timepoint [12] 338429 0
Measured at hospital discharge, and 3 and 6 months post-operative. Also measured before surgery if the patient is at least 7 days out from their scheduled surgery date.
Secondary outcome [13] 338437 0
Economic analyses measured with the the European Quality of Life (EQ-5D-5L)
Timepoint [13] 338437 0
Measured at baseline (pre-operatively), and 3, 6 and 12 months post-operative
Secondary outcome [14] 338441 0
Cost of delivering the intervention measured using records of time and cost for intervention sessions (for intervention participants only)
Timepoint [14] 338441 0
Measured at 3 months post-operatively (on completion of the intervention)
Secondary outcome [15] 338442 0
Quadriceps muscle strength measured by hand held dynamometry
Timepoint [15] 338442 0
Measured at baseline (pre-operatively), hospital discharge, 3 and 6 months post-operative
Secondary outcome [16] 338443 0
Fatigue measured with the Brief Fatigue Inventory
Timepoint [16] 338443 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [17] 338444 0
Financial toxicity: measured with the COmprehensive Score for financial Toxicity (COST) questionnaire
Timepoint [17] 338444 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [18] 338445 0
Return to work: measured with the Employment questionnaire
Timepoint [18] 338445 0
Measured 3, 6 and 12 months post-operative
Secondary outcome [19] 338446 0
Qualitative participant feedback about the intervention program and barriers/enablers to continue exercising post-intervention measured in a random subset of participants in the intervention group using semi-structured qualitative interviews. Interviews will be conducted until data saturation is reached.
Timepoint [19] 338446 0
Measured at 3 months post-operatively after the end of the intervention period.
Secondary outcome [20] 338541 0
Distress measured by the distress thermometer
Timepoint [20] 338541 0
Measured at baseline (pre-operatively), 3 and 6 months post-operative
Secondary outcome [21] 339035 0
Hand grip strength measured by dynamometry
Timepoint [21] 339035 0
Measured at baseline (pre-operatively), hospital discharge, 3 and 6 months post-operative

Eligibility
Key inclusion criteria
- Adults, aged 18 years or over
- Able to provide consent
- Planned to receive surgical treatment for non-small cell lung cancer (NSCLC)
- Expected to be alive > 6 months
- Eastern Cooperate Oncology Group (ECOG) performance status of 0-2 at study entry
- Not currently meeting the physical activity guidelines (150 minutes of moderate intensity physical activity or 75 minutes of vigorous physical activity per week)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-English speaking (insufficient English language skills to complete the questionnaires)
- Metastatic disease (stage IV lung cancer)
- Acute uncontrolled cardiovascular or respiratory issues
- Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, or acute coronary syndrome
- Non-ambulant (for example: amputee, spinal cord injury, wheel-chair bound)
- ECOG performance status of 3 or 4 at study entry
- Cognitive impairment (determined as not being able to provide consent for surgery)

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)
The randomisation list will be devised by the independent statistician and carried out via the randomisation module within the REDCap database. Following consent and assessment, participants are randomised 1:1 (intervention or usual care) stratified by hospital site. Randomisation will occur following surgery (following completion of all study measures). The intervention will not occur until after randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation will be performed by 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
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analyses will be performed including all randomised participants in their allocated group arm. A constrained longitudinal data analysis model will be used to analyse the primary outcome (EORTC QLQ c30) across all time points (baseline, 3, 6 and 12 months after surgery), with study group, time point and a study group by time point interaction, and recruitment site included in the model. The model will be restricted to have a common baseline mean score across the study groups based on the assumption that there are no differences in the mean outcome between groups at baseline due to randomisation. The absolute difference in mean change in EORTC QLQ c30 physical function domain from baseline between groups will be estimated (including two-sided 95% confidence interval) at 3-months after surgery (primary time point). The constrained longitudinal data analysis model provides valid inference if the missing data mechanism is at most missing at random. Similar analyses will be conducted for the secondary outcomes. The complier average causal effect will be estimated in primary outcome analyses, in addition to the intention-to-treat effect, using collected adherence data. Heterogeneity of the intervention effect according to post-operative cancer treatment (no post-operative treatment/post-operative chemotherapy, radiotherapy or chemoradiotherapy) will be assessed in exploratory analyses by including interactions between post-operative treatment and study group. The number and percentage of participants with adverse events will be summarised by study group. A health economic analysis run alongside the clinical trial.

Qualitative data will be analysed using directed content analysis. Braun and Clarke’s six steps of reflexive thematic analysis will be used to find and organise data into codes informed by the Theoretical Domains Framework (TDF) and Theoretical Framework of Acceptability (TFA) by two independent researchers.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/11/2017
Actual
23/11/2017
Date of last participant enrolment
Anticipated
30/06/2022
Actual
11/07/2022
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
112
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8461 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 20655 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 16545 0
3050 - Parkville
Recruitment postcode(s) [2] 35445 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 296867 0
Government body
Name [1] 296867 0
Victorian Cancer Agency - Clinical Research Fellowship
Country [1] 296867 0
Australia
Funding source category [2] 301581 0
University
Name [2] 301581 0
The University of Melbourne - 2019 Melbourne Research Grant Support Scheme
Country [2] 301581 0
Australia
Funding source category [3] 309816 0
Charities/Societies/Foundations
Name [3] 309816 0
Cancer Council Victoria - Grant in Aid Funding
Country [3] 309816 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
161 Barry Street, Parkville 3010 Victoria
Country
Australia
Secondary sponsor category [1] 296026 0
Hospital
Name [1] 296026 0
Royal Melbourne Hospital
Address [1] 296026 0
Grattan Street, Parkville, VIC 3010
Country [1] 296026 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298093 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 298093 0
Ethics committee country [1] 298093 0
Australia
Date submitted for ethics approval [1] 298093 0
30/05/2017
Approval date [1] 298093 0
24/08/2017
Ethics approval number [1] 298093 0
HREC2017.152 (ethics number HREC/17/MH/182)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75966 0
Prof Catherine Granger
Address 75966 0
The University of Melbourne
Level 7, Alan Gilbert Building, 161 Barry Street, Parkville 3010, VIC
Country 75966 0
Australia
Phone 75966 0
+613 8344 8126
Fax 75966 0
Email 75966 0
[email protected]
Contact person for public queries
Name 75967 0
Catherine Granger
Address 75967 0
The University of Melbourne
Level 7, Alan Gilbert Building, 161 Barry Street, Parkville 3010, VIC
Country 75967 0
Australia
Phone 75967 0
+613 8344 8126
Fax 75967 0
Email 75967 0
[email protected]
Contact person for scientific queries
Name 75968 0
Catherine Granger
Address 75968 0
The University of Melbourne
Level 7, Alan Gilbert Building, 161 Barry Street, Parkville 3010, VIC
Country 75968 0
Australia
Phone 75968 0
+613 8344 8126
Fax 75968 0
Email 75968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Details unclear at this stage


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6728Study protocolGranger CL, Edbrooke L, Antippa P, Wright G, McDonald CF, Lamb KE, Irving L, Krishnasamy M, Abo S, Whish-Wilson GA, Truong D, Denehy L, Parry SM. Effect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): protocol for a randomised controlled trial. BMJ Open Respir Res. 2022 Jan;9(1):e001189. doi: 10.1136/bmjresp-2021-001189. PMID: 35039313; PMCID: PMC8765028.https://bmjopenrespres.bmj.com/content/9/1/e001189[email protected]
6729Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a postoperative home-based exercise and self-management programme on physical function in people with lung cancer (CAPACITY): Protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjresp-2021-001189
N.B. These documents automatically identified may not have been verified by the study sponsor.