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Enhancing treatment outcomes after gynaecological cancer (ACUMEN For ALL): Using telehealth exercise delivery to promote health after cancer therapy

Enhancing treatment outcomes after gynaecological cancer (ACUMEN For ALL): Investigating the effect of telehealth exercise on health-related quality of life after cancer therapy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000898752
Acronym
ACUMEN For ALL
Enrollment
50
Registered
2022-06-23
Start date
2022-06-30
Completion date
2023-06-30
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ACUMEN For ALL trial will examine the feasibility and safety of telehealth delivery of supervised exercise and outcome assessment in a subset of women treated for gynaecological cancer living in demographically-challenged circumstances that preclude face-to-face delivery and outcome assessment. Assess the preliminary effectiveness of telehealth-delivered intervention to improve quality of life in women and preliminary utility of telehealth-mediated outcome assessment. Understand the factors that indicate implementation potential. Who is it for? If you are an adult woman who has been diagnosed with gynaecological cancer in the last 60 months, and it has been over a month since you finished an intensive cancer treatment (including surgery, radiotherapy, chemotherapy), within more remote areas of Queensland or those who have access to the internet but are limited by transportation and/or location and would otherwise be ineligible for the main ACUMEN trial. Women will be identified for inclusion in this sub-study if they are unable or unwilling to attend face-to-face exercise training and objective outcome assessment. Study details Participants in this study will be randomly allocated to receive a video-delivered exercise intervention or delayed intervention control after 12 weeks. This comprises a video-delivered baseline assessment (including subjective and objective outcomes) with a trained accredited exercise physiologist or physiotherapist to determine their current fitness levels, after this time, all outcomes will be reassessed via video-delivery in the same manner as at 12 weeks, and repeated 12 weeks later (at Week 24). Participants in this first group will then be prescribed a personalised exercise program that they will follow for the next 12 weeks. The exercise program will include both aerobic and resistance training and participants will be asked to complete 3x 60 minute sessions each week for the 12 week period which will include supervised and unsupervised sessions. The second group will receive a delayed commencement of the personalised exercise program 12 weeks later. Participants in both groups will complete a series of questionnaires, and fitness assessments before and after the intervention. After the intervention, questionnaires, and fitness assessments will occur at two time-points (week 12 and week 24). It is hoped this research will determine whether a personalised exercise program can lead to improved long-term health outcomes for women who have been treated for gynaecological cancer.

Interventions

The total study period is 24 weeks. It comprises of a 12-week exercise training intervention and a 12-week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or waitlist-control group. Participants in the delayed intervention control group will complete a 12-week control period, they will then be eligible for the intervention and the same outcome assessments will be repeated. The telehealth intervention has two

The total study period is 24 weeks. It comprises of a 12-week exercise training intervention and a 12-week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or waitlist-control group. Participants in the delayed intervention control group will complete a 12-week control period, they will then be eligible for the intervention and the same outcome assessments will be repeated. The telehealth intervention has two components, an exercise component underpinned by a behavioural component. Both will be delivered via video-link by an accredited exercise physiologist or physiotherapist (AEPP) trained in cancer care. The exercise component is structured over 12 weeks and adheres to Exercise and Sports Science Australia recommendations, including Adult Pre-Exercise Screening System (APPS form) for risk of adverse event due to exercise. Goals will be prioritised and set, and the prescription co-designed with the participant, including strategies for longer-term maintenance. The intervention will adhere to ESSA guidelines: 1. The goal is to enhance neuromuscular strength, endurance, balance, flexibility, and cardiorespiratory fitness. The AEPP will individually tailor exercise to the functional capacity of each participant towards these goals, cognisant of participant restrictions. 2. Up to 3 x 60-minute exercise sessions per week, individually prescribed by an AEPP. The session will aim for an aerobic component (up to 40 minutes moderate-to-vigorous intensity based on a percentage range of age-predicted heart rate maximum) such as jogging -on-the-spot or fast walking and resistance component (2 x 8-12+ repetitions of major muscle group exercises at >6-10 on the OMNI perceived exertion scale, where 0=extremely easy to 10=extremely hard) such as push-ups, lunges, squats, rowing. High-intensity aerobic exercise may be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and closely monitored by the AEPP. Exercise intensity during exercise sessions will be monitored by heart rate on the Fitbit watch, and by rating of perceived exertion using the 6-20 Borg Scale. 3. For the first six-weeks, the AEPP will directly supervise and prescribe two individual 60 minute sessions per week via Zoom (Zoom Video Communications, USA) and provide prescription for one self-managed home session. 4. In Weeks 7-12, participants will be asked to attend one supervised 60 minute Zoom session per week. Participants will also complete two self-managed, home based exercise sessions. 5. The AEPP will deliver all sessions from Wesley Choices, Wesley gym, UQ, or a private and undisturbed location using a laptop, while participants will be asked to participate from their home or another location of their choosing. The exercise intervention will be complemented by a behavioural component integrated within each exercise session. The behavioural component will enable the AEPP to help the participant define realistic achievable goals and facilitate exercise maintenance beyond the study period. The exercise intervention will therefore be complemented by a behavioural component. The aim of the behavioural component is to instil exercise self-efficacy, which refers to the person’s willingness to respond to challenges, how hard they will work at challenges, and the extent to which they will persist despite adversity or set-backs. The behavioural component will enable the AEPP to help the participant define realistic achievable goals, encourage them to achieve the desired exercises, give participants insights into the success of others in similar circumstances, and facilitate exercise maintenance beyond the study period. The AEPP will be trained in the following specific strategies demonstrated to promote self-efficacy: 1. Collaborating with the participant to define realistic goals that are specific, achievable and measurable. As the individual successfully reaches those goals (performance accomplishment), this in turn promotes optimism and willingness to persist despite set-backs. 2. Providing information about success of others (vicarious experience), which instils the notion of “If they can do it, so can I”. 3. Encouragement by the AEPP (verbal persuasion), which is demonstrated to increase motivation. 4. Attention to emotional arousal including cognitive distortions, and challenging preconceived ideas or misperceptions about exercise that can otherwise pose a barrier. Intervention training for AEPPs will be multimodal. First, a self-directed training manual will describe the common physical and psychological consequences of the diagnosis and treatment of reproductive cancer. This will be supplemented by a day-long skills development session that will focus on empathic engagement, the principles of chronic disease self-management, motivational interviewing, encouraging exercise self-efficacy and techniques to challenge cognitive distortions. Third, clinical supervision from experienced psycho-oncology clinicians and specialist oncology AEPPs will be available for AEPPs as our previous research has demonstrated that this is a central aspect of promoting the confidence of health professionals to deliver this type of intervention. Duration and intensity of daily physical activities will be tracked during the monitoring period. All participants will be required to wear a FitBit throughout their maintenance period to accurately track the intensity of daily physical activities, including the unsupervised exercise sessions.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Women aged 18 years or older diagnosed with cancer of the ovary, cervix, Fallopian tubes, placenta, endometrium, vagina or vulva in the previous 60 months, including early, recurrent, advanced or metastatic cancer. 2. > 1 month since end of intensive cancer treatment (including surgery, radiotherapy, chemotherapy). Supportive therapies such as bisphosphonate, pain medication and hormone replacement allowable. 3. Resident in Australia. 4. Have access to the internet. 5. Own, or have access to, a computer or mobile device. 6. Willing and able to comply with all study requirements, including intervention, timing and nature of required assessments. 7. Able to speak and read in English to ensure consent is informed and documentation of participant-reported outcome measures can be adhered to. 8. Can provide voluntary written informed consent. 9. Unable or unwilling to attend face-to-face exercise training and objective outcome assessment.

Exclusion criteria

1. Any clinical contraindication that precludes safe completion of the program in the judgement of the project team. 2. No intensive cancer treatments while enrolled. 3. In the care of an exercise professional at the time of enrolment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026