Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000042842
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
18/01/2021
Date last updated
22/02/2023
Date data sharing statement initially provided
18/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise during CHemotherapy for Recurrent Ovarian cancer (ECHO-R)
Scientific title
A Phase II trial evaluating feasibility, safety and efficacy of an individually-tailored exercise intervention during chemotherapy for recurrent ovarian cancer
(ECHO-R)
Secondary ID [1] 302160 0
None
Universal Trial Number (UTN)
Trial acronym
ECHO-R
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Ovarian Cancer 318812 0
Condition category
Condition code
Cancer 316823 316823 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise intervention:
The intervention will span 6 months and involve the individual prescription of aerobic and resistance-based exercise, with a dosage target of at least 150 minutes per week at moderate-intensity (moderate intensity = RPE of 11-13 on Borg RPE 6-20 scale). Examples of exercises that are likely to be prescribed include: aerobic exercise - walking, cycling, cycle/rowing ergometers, aerobics; resistance exercise - sessions focussing on major muscle groups, utilising bodyweight, free weights, exercise bands and/or gym equipment (e.g., sit-to-stands, barbell chest press, exercise-band shoulder press, cable row). The location of prescribed exercise (e.g., home-based, local neighbourhood/ parks, gym) will depend on what is appropriate and preferred by each participant.
An Exercise Professional (ExP; undergraduate training in exercise science) with study-specific prescription training will prescribe and monitor exercise type, duration and frequency on a regular basis and modify prescription according to the presentation of symptoms and by adhering to the exercise principle of gradual progression.
Across the 6-month intervention, approximately 12 telephone/video-health exercise sessions between participants and their allocated ExP will be scheduled, with an average duration of each contact being approximately 60 minutes. The foundation intervention schedule is as follows:
weeks 1 to 4 - once per week (4 sessions) weeks 5 to 16 - once per fortnight (6 sessions) weeks 17 to 26 – one per month (2-3 sessions)
In the context of this pragmatic trial, women experiencing difficulty adhering to the prescribed exercise dose will be provided with more telehealth sessions (maximum number of sessions: 20 sessions). Less frequent contact may occur for those adhering to their exercise prescription and for whom weekly contact is therefore unnecessary or burdensome to the participant (minimum number of sessions: 8). When possible and when participants approve, the telehealth intervention will be supported by 5 face-to face visits with an exercise professional scheduled throughout the intervention (this intervention feature aligns with Australia’s Chronic Disease Management Plan, which allows for up to 5 reimbursable visits per year with an accredited Exercise Physiologist or Physiotherapist. Duration of these sessions will be approximately 60 minutes). These visits will occur at a location convenient to the participant (e.g., local park or exercise clinic; participant's home)

Intervention adherence (i.e., participant attendance at scheduled sessions), fidelity (i.e., quality of delivery: exercise prescribed by ExPs; delivered dose: exercise completed by participants) will be assessed by the senior exercise physiologist (>10 years clinical experience) via monthly review of ExP session notes and patient-reported exercise doses. Participants struggling to adhere to the intervention schedule or exercise dosage will be offered modified contact with the ExP.
Intervention code [1] 318458 0
Treatment: Other
Intervention code [2] 318459 0
Rehabilitation
Intervention code [3] 318460 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325595 0
Feasibility of 6-month exercise intervention: Weekly exercise dose completed (MET-minutes = minutes of exercise completed x intensity of exercise completed [Borg RPE; 6-20]), as assessed by participant exercise log and reported at each contact with exercise professional (contact = every 1-4 weeks across 6 month intervention)
Timepoint [1] 325595 0
6 months post-baseline (end of intervention), data collected throughout intervention.
Primary outcome [2] 325673 0
Safety of exercise intervention: number of exercise-related adverse events (e.g., muscle pain) as self-reported by participants or observed by exercise professional.
Timepoint [2] 325673 0
During 6 month intervention: participants are asked by their exercise professional about the occurrence of any adverse events at each exercise session (every 1-4 weeks), as well as asked to contact their ExP to report any serious adverse events that occur between contacts.
Primary outcome [3] 325674 0
Health-related quality of life (FACT-O, Functional Assessment of Cancer Therapy-Ovarian): change in score between pre- and post-intervention
Timepoint [3] 325674 0
Baseline, 6 months post-baseline (end of 6 month intervention - primary endpoint), 9 months post-baseline (follow-up)
Secondary outcome [1] 388737 0
Physical function: change in 6 minute walk test distance between pre- and post-intervention
Timepoint [1] 388737 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [2] 407002 0
Change in 30-second sit to stand between pre- and post-intervention
Timepoint [2] 407002 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [3] 407003 0
Change in handgrip strength (portable dynamometer) between pre- and post-intervention
Timepoint [3] 407003 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [4] 407004 0
Change in chest strength (portable dynamometer) between pre- and post-intervention
Timepoint [4] 407004 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [5] 407005 0
Change in leg strength (Knee flexion; portable dynamometer) between pre- and post-intervention
Timepoint [5] 407005 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [6] 407006 0
Change in balance (single leg stance test) between pre- and post-intervention
Timepoint [6] 407006 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [7] 407007 0
Change in self-reported physical activity level (Active Australia Survey) between pre- and post-intervention
Timepoint [7] 407007 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [8] 407008 0
Change in body composition (bioimpedance spectroscopy) between pre- and post-intervention
Timepoint [8] 407008 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [9] 407009 0
Change in lymphoedema (bioimpedance spectroscopy) between pre- and post-intervention
Timepoint [9] 407009 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [10] 407010 0
Change in self-reported fatigue (FACIT-Fatigue scale) between pre- and post-intervention
Timepoint [10] 407010 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [11] 407011 0
Change in self-reported peripheral neuropathy (FACT-GOG_NTX) between pre- and post-intervention
Timepoint [11] 407011 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [12] 407012 0
Change in self-reported sleep quality (Pittsburg Sleep Quality Index) between pre- and post-intervention
Timepoint [12] 407012 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [13] 407013 0
Change in pain (0-10 pain scale item from MOST: Measure of Ovarian Symptoms and Treatment Concerns) between pre- and post-intervention
Timepoint [13] 407013 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [14] 407014 0
Change in self-reported lymphoedema and lower-limb swelling (self-reported via questionnaire) between pre- and post-intervention.

The self-report LE outcome is assessed via participant-completed questionnaire. The outcome is not validated but is the same as that successfully used in the LEGS study - gynaecological cancer cohort study involving >400 women with malignant disease (reference below). Questions include the date of lymphoedema diagnosis, the type of health professional who made the diagnosis, the location, severity and duration of the lymphoedema, and, types of lymphoedema treatments participants have had.

LEGS study: Hayes SC, Janda M, Ward LC, Reul-Hirche H, Steele ML, Carter J, Quinn M, Cornish B, Obermair A. Lymphedema following gynecological cancer: Results from a prospective, longitudinal cohort study on prevalence, incidence and risk factors. Gynecol Oncol. 2017 Sep;146(3):623-629.
Timepoint [14] 407014 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [15] 407015 0
Change in self-reported anxiety and depression (Hospital anxiety and depression scale) between pre- and post-intervention
Timepoint [15] 407015 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [16] 407016 0
Change in self-reported hope (Herth Hope Index [modified 7-item scale) between pre- and post-intervention
Timepoint [16] 407016 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [17] 407017 0
Intervention cost-consequences (EQ-5D-5L and intervention cost records)
Timepoint [17] 407017 0
Baseline, throughout intervention and 6 months post-baseline (end of intervention)
Secondary outcome [18] 407018 0
Survival (patient status, timing, and cause of death, via chart review, access of death registry, or contact with treating doctor)
Timepoint [18] 407018 0
End of study (approximately 2 years post-baseline of first participant)
Secondary outcome [19] 407019 0
Change in symptoms and treatment concerns (MOST: Measure of Ovarian Symptoms and Treatment concerns) between pre- and post-intervention
Timepoint [19] 407019 0
Baseline, 6 months post-baseline (end of intervention), 9 months post-baseline (follow up)
Secondary outcome [20] 407020 0
Perceived benefits from the intervention (semi-structured interviews with a subgroup of participants)

Participants will be invited to take part in the interviews in the order they complete the intervention and we will continue inviting participants to take part in interviews until data saturation has been reached.
Timepoint [20] 407020 0
6 months post-baseline (end of intervention)

Eligibility
Key inclusion criteria
Women with recurrent ovarian, peritoneal or fallopian tube cancer of all types (including epithelial, germ cell, stromal, granulosa cell) and a platinum-free interval of at least 6 months (platinum-sensitive disease)
2. Scheduled to receive, or currently receiving, chemotherapy (of any type).
3. Age 18 years or over
4. Willing and able to comply with all study requirements, including the exercise intervention, timing and nature of required assessments (note: face to face assessment is dependant on factors including timing and location, and does not constitute an exclusion criteria).
5. Sufficiently fluent in English to fully participate in data collection requirements and comprehend intervention requirements
6. Signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
NOTE: Since exercise safety has been demonstrated in a range of chronic disease settings such as cardiovascular disease, osteoarthritis and stroke, and the intervention is tailored to each woman’s capacity, the presence of other co-morbidities will NOT preclude participation if all other eligibility criteria are met.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Summary baseline statistics for study sample will be presented using counts and percentages for categorical variables or means [SD] and medians (minimum, maximums) for parametric and non- parametric continuously-scaled variables, respectively. Primary outcomes of feasibility and safety will be reported descriptively, as number (%) and group medians (minimum, maximum) when relevant. Health-related quality of life will be assessed using generalised estimating equations (GEE) to determine time (baseline, post-intervention, 9-month follow-up) effects and to explore the relationship between patient, treatment and behavioural characteristics and time effects. Estimated means, 95% confidence intervals (CI) and p-values will be reported. GEEs are a robust way of analysing longitudinal outcomes, coping well with missing data, having appealing properties such as the “sandwich” estimator, and present population mean outcomes (rather than individual patient). As such, the use of GEEs is preferred over mixed models

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
26/02/2021
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
80
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17951 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 17952 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [3] 17953 0
The Wesley Hospital - Auchenflower
Recruitment hospital [4] 17954 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [5] 17955 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 17956 0
Mater Private Hospital - South Brisbane
Recruitment hospital [7] 24100 0
Griffith University – Nathan Campus - Nathan
Recruitment postcode(s) [1] 31816 0
4029 - Herston
Recruitment postcode(s) [2] 31817 0
4000 - Brisbane
Recruitment postcode(s) [3] 31818 0
4066 - Auchenflower
Recruitment postcode(s) [4] 31819 0
4101 - South Brisbane
Recruitment postcode(s) [5] 31820 0
4215 - Southport
Recruitment postcode(s) [6] 39608 0
4111 - Nathan

Funding & Sponsors
Funding source category [1] 306588 0
Government body
Name [1] 306588 0
National Health and Medical Research Council (NHMRC)
Country [1] 306588 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Menzies Health Institute Queensland
G40 Griffith Health Centre, Level 8.86
Gold Coast campus
Griffith University QLD 4222
Country
Australia
Secondary sponsor category [1] 307713 0
None
Name [1] 307713 0
Address [1] 307713 0
Country [1] 307713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306770 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 306770 0
Ethics committee country [1] 306770 0
Australia
Date submitted for ethics approval [1] 306770 0
31/08/2020
Approval date [1] 306770 0
06/11/2020
Ethics approval number [1] 306770 0
HREC/2020/QRBW67223

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

Contacts
Principal investigator
Name 104966 0
Prof Sandi Hayes
Address 104966 0
Griffith University
Nathan Campus
170 Kessels Rd,
Nathan QLD 4111
Country 104966 0
Australia
Phone 104966 0
+61 7 3735 5194
Fax 104966 0
n/a
Email 104966 0
[email protected]
Contact person for public queries
Name 104967 0
Sheree Rye
Address 104967 0
Griffith University
Nathan Campus
170 Kessels Rd,
Nathan QLD 4111
Country 104967 0
Australia
Phone 104967 0
+61 7 3382 1237
Fax 104967 0
n/a
Email 104967 0
[email protected]
Contact person for scientific queries
Name 104968 0
Sandi Hayes
Address 104968 0
Griffith University
Nathan Campus
170 Kessels Rd,
Nathan QLD 4111
Country 104968 0
Australia
Phone 104968 0
+61 7 3382 1237
Fax 104968 0
n/a
Email 104968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data, deidentified – dependent variables and patient characteristics.
When will data be available (start and end dates)?
Following the publication of outcome data (safety, feasibility, and effect) through to December 2038 (end of study +15 years).
Available to whom?
Researchers conducting meta-analyses that are to be submitted to peer-review. Requestors must provide a methodologically sound proposal and agree to a data access agreement.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Proposals should be directed to Principal Investigator: Sandi Hayes, email [email protected].
Data will be made available as deidientified files to be transferred via secure file transfer protocol.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10035Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4153Plain language summaryNo NA

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